Trial Outcomes & Findings for Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions (NCT NCT01305356)
NCT ID: NCT01305356
Last Updated: 2018-12-26
Results Overview
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
299 participants
Primary outcome timeframe
Baseline, 9, 12, 16, 24, 36, and 52 weeks
Results posted on
2018-12-26
Participant Flow
A propensity score matching analysis was performed in order to identify a single set of investigational and control subjects derived from the datasets (BMTI-2006-01, BMTI-2009-01, BMTI-2010-01) that were comparable and could be evaluated for the purpose of assessing the safety and effectiveness of AUGMENT® Injectable.
Participant milestones
| Measure |
Augment® Injectable Bone Graft
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
167
|
|
Overall Study
COMPLETED
|
132
|
167
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Baseline characteristics by cohort
| Measure |
Augment® Injectable Bone Graft
n=132 Participants
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
Augment® Injectable Bone Graft: Implantation of up to 9cc of Augment® Injectable Bone Graft
|
Autologous Bone Graft
n=167 Participants
Standard Rigid Fixation + Autologous bone graft
Autologous bone graft: Implantation of up to 9cc of autologous bone graft
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Affected Foot/Ankle
Ankle fusion
|
31 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Affected Foot/Ankle
Subtalar fusion
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Affected Foot/Ankle
Calcaneocuboid fusion
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Affected Foot/Ankle
Talonavicular fusion
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Affected Foot/Ankle
Double fusion
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Affected Foot/Ankle
Triple arthordesis
|
19 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ever smoked
No
|
61 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ever smoked
Yes
|
71 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 9, 12, 16, 24, 36, and 52 weeksPopulation: Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Outcome measures
| Measure |
Augment® Injectable Bone Graft
n=132 Participants
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 Participants
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
Pain on Weight Bearing
Baseline
|
71.0 units on a scale
Standard Error 2.0
|
70.7 units on a scale
Standard Error 1.8
|
|
Pain on Weight Bearing
Week 9
|
29.5 units on a scale
Standard Error 2.9
|
28.2 units on a scale
Standard Error 2.5
|
|
Pain on Weight Bearing
Week 12
|
26.8 units on a scale
Standard Error 2.5
|
24.6 units on a scale
Standard Error 2.2
|
|
Pain on Weight Bearing
Week 16
|
26.4 units on a scale
Standard Error 2.4
|
24.4 units on a scale
Standard Error 2.1
|
|
Pain on Weight Bearing
Week 24
|
25.1 units on a scale
Standard Error 2.4
|
18.3 units on a scale
Standard Error 2.1
|
|
Pain on Weight Bearing
Week 36
|
18.7 units on a scale
Standard Error 2.3
|
15.8 units on a scale
Standard Error 2.0
|
|
Pain on Weight Bearing
Week 52
|
16.6 units on a scale
Standard Error 2.4
|
15.9 units on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline, 9, 12, 16, 24, 36, and 52 weeksPopulation: Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.
The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.
Outcome measures
| Measure |
Augment® Injectable Bone Graft
n=132 Participants
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 Participants
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
Foot Function Index (FFI)
52 Weeks
|
19.6 units on a scale
Standard Error 1.9
|
16.9 units on a scale
Standard Error 1.6
|
|
Foot Function Index (FFI)
Baseline
|
50.6 units on a scale
Standard Error 1.6
|
50.0 units on a scale
Standard Error 1.4
|
|
Foot Function Index (FFI)
9 Weeks
|
41.8 units on a scale
Standard Error 1.7
|
45.0 units on a scale
Standard Error 1.5
|
|
Foot Function Index (FFI)
12 Weeks
|
33.3 units on a scale
Standard Error 1.8
|
34.5 units on a scale
Standard Error 1.6
|
|
Foot Function Index (FFI)
16 Weeks
|
29.7 units on a scale
Standard Error 2.0
|
28.0 units on a scale
Standard Error 1.7
|
|
Foot Function Index (FFI)
24 Weeks
|
26.3 units on a scale
Standard Error 1.8
|
19.8 units on a scale
Standard Error 1.6
|
|
Foot Function Index (FFI)
36 Weeks
|
21.8 units on a scale
Standard Error 1.8
|
16.7 units on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline, 9, 12, 16, 24, 36, and 52 weeksPopulation: Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.
Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.
Outcome measures
| Measure |
Augment® Injectable Bone Graft
n=132 Participants
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 Participants
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
AOFAS Hindfoot and Ankle Score
Baseline
|
43.3 units on a scale
Standard Error 1.5
|
43.6 units on a scale
Standard Error 1.3
|
|
AOFAS Hindfoot and Ankle Score
9 Weeks
|
61.5 units on a scale
Standard Error 1.1
|
61.5 units on a scale
Standard Error 1.0
|
|
AOFAS Hindfoot and Ankle Score
12 Weeks
|
66.9 units on a scale
Standard Error 1.3
|
66.6 units on a scale
Standard Error 1.1
|
|
AOFAS Hindfoot and Ankle Score
16 Weeks
|
69.9 units on a scale
Standard Error 1.3
|
71.2 units on a scale
Standard Error 1.1
|
|
AOFAS Hindfoot and Ankle Score
24 Weeks
|
73.4 units on a scale
Standard Error 1.5
|
75.5 units on a scale
Standard Error 1.3
|
|
AOFAS Hindfoot and Ankle Score
36 Weeks
|
77.5 units on a scale
Standard Error 1.5
|
78.9 units on a scale
Standard Error 1.3
|
|
AOFAS Hindfoot and Ankle Score
52 Weeks
|
79.5 units on a scale
Standard Error 1.6
|
79.3 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline, 9, 12, 16, 24, 36, and 52 weeksPopulation: Analysis conducted on patients at Baseline, 9, 12, 16, 24, 36, and 52 weeks time points.
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Outcome measures
| Measure |
Augment® Injectable Bone Graft
n=132 Participants
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 Participants
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
Fusion Site Pain
Week 24
|
20.9 units on a scale
Standard Error 2.2
|
15.3 units on a scale
Standard Error 1.9
|
|
Fusion Site Pain
Week 36
|
17.4 units on a scale
Standard Error 2.1
|
12.4 units on a scale
Standard Error 1.8
|
|
Fusion Site Pain
Baseline
|
51.4 units on a scale
Standard Error 2.4
|
50.4 units on a scale
Standard Error 2.1
|
|
Fusion Site Pain
Week 9
|
20.5 units on a scale
Standard Error 2.1
|
15.4 units on a scale
Standard Error 1.8
|
|
Fusion Site Pain
Week 12
|
18.9 units on a scale
Standard Error 2.1
|
17.8 units on a scale
Standard Error 1.8
|
|
Fusion Site Pain
Week 16
|
21.7 units on a scale
Standard Error 2.2
|
18.9 units on a scale
Standard Error 2.0
|
|
Fusion Site Pain
Week 52
|
15.8 units on a scale
Standard Error 2.2
|
12.6 units on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Baseline, 9, 12, 16, 24, 36, and 52 weeksPopulation: Analysis conducted on patients at Baseline, 12, 16, 24, 36, and 52 weeks time points.
The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.
Outcome measures
| Measure |
Augment® Injectable Bone Graft
n=132 Participants
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 Participants
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
SF-12 Physical Component Score
Baseline
|
30.8 units on a scale
Standard Error 0.8
|
30.8 units on a scale
Standard Error 0.7
|
|
SF-12 Physical Component Score
Week 12
|
36.9 units on a scale
Standard Error 0.8
|
36.3 units on a scale
Standard Error 0.7
|
|
SF-12 Physical Component Score
Week 16
|
37.9 units on a scale
Standard Error 0.8
|
39.0 units on a scale
Standard Error 0.7
|
|
SF-12 Physical Component Score
Week 24
|
40.3 units on a scale
Standard Error 0.9
|
42.2 units on a scale
Standard Error 0.7
|
|
SF-12 Physical Component Score
Week 36
|
42.1 units on a scale
Standard Error 0.9
|
44.5 units on a scale
Standard Error 0.8
|
|
SF-12 Physical Component Score
Week 52
|
42.9 units on a scale
Standard Error 0.9
|
45.5 units on a scale
Standard Error 0.8
|
Adverse Events
Augment® Injectable Bone Graft
Serious events: 20 serious events
Other events: 116 other events
Deaths: 0 deaths
Autologous Bone Graft
Serious events: 35 serious events
Other events: 135 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Augment® Injectable Bone Graft
n=132 participants at risk
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 participants at risk
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Blood and lymphatic system disorders
Anemia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Arrhythmia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Congenital, familial and genetic disorders
Congenital foot malformation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
gastrointestinal hemorrhage
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Impaired healing
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Immune system disorders
Hypersensitivity
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Pneumonia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Wound infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Suicidal ideation
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Ureteric injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Aneurysm
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Hematoma
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Device related infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Wound infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
Other adverse events
| Measure |
Augment® Injectable Bone Graft
n=132 participants at risk
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
|
Autologous Bone Graft
n=167 participants at risk
Standard Rigid Fixation + Autologous bone graft
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.2%
20/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
7.2%
12/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Feeling Hot
|
12.1%
16/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.6%
6/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Local Swelling
|
20.5%
27/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
7.8%
13/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Medical Device Discomfort
|
5.3%
7/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Pyrexia
|
5.3%
7/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Tenderness
|
16.7%
22/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
4.8%
8/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.2%
28/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
11.4%
19/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.8%
9/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
4.2%
7/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.3%
7/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
44/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
21.0%
35/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Headache
|
5.3%
7/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Hypoaesthesia
|
7.6%
10/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
6.0%
10/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Blood and lymphatic system disorders
Anemia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Arrhythmia
|
3.0%
4/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Chest discomfort
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Syncope
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Congenital, familial and genetic disorders
Congenital foot malformation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Ear and labyrinth disorders
Labyrinthitis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Endocrine disorders
Diabetes mellitus
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Endocrine disorders
Diabetic neuropathy
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Eye disorders
Cataract
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Eye disorders
Chalazion
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Eye disorders
Eye pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Eye disorders
Optic disc disorder
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
2.4%
4/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Flatulence
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Procedural nausea
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Tooth infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Toothache
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
4/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
4.8%
8/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Administration site pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Chills
|
3.0%
4/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Impaired healing
|
4.5%
6/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Inflammation
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Necrosis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Non-cardiac chest pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Oedema
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Oedema peripheral
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.6%
6/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Pain
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Swelling
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Ulcer
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Immune system disorders
Hypersensitivity
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Bronchitis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Cellulitis
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Cystitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Ear infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Fungal skin infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Herpes zoster
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Infection
|
3.0%
4/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Influenza
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Localised infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.6%
6/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Onychomycosis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Pneumonia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Sinusitis
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Staphylococcal infection
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Tooth abscess
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Wound infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haematoma
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Blister
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Bursa injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
4/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Device related infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
4.8%
8/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Graft infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.6%
6/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Medical device site reaction
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Necrotic preservation injury of graft
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Nerve compression
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Peroneal nerve injury
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Post procedural cellulitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Postoperative wound infection
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Wound infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Blood creatinine increased
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Blood urea increased
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Urine analysis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Gout
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Oedema
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthritis infective
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint sprain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.0%
4/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cyst
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Dizziness
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Hyperpathia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Insomnia
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Neuralgia
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.6%
6/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Paraesthesia
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Peroneal nerve injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Sensory loss
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Sinus headache
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Tarsal tunnel syndrome
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Tension headache
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Tremor
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Urinary incontinence
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Depression
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Insomnia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Suicidal ideation
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Dysuria
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Incontinence
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Ureteric injury
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
2.4%
4/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Reproductive system and breast disorders
Prostatitis
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Application site vesicles
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.5%
6/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.8%
3/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Eschar
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Onychomycosis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
3.0%
5/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
5/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
2.4%
4/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic keratosis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Splinter haemorrhages
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Cast application
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Endodontic procedure
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Gastric banding
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Incisional drainage
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Mole excision
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Splint application
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Ureteral stent removal
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Wound drainage
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Aneurysm
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
3/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
2.4%
4/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Haematoma
|
1.5%
2/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Hypertension
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Hypotension
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.2%
2/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Procedural hypertension
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Rectal haemorrhage
|
0.76%
1/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/132 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.60%
1/167 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place