Trial Outcomes & Findings for Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions (NCT NCT00583375)
NCT ID: NCT00583375
Last Updated: 2018-04-02
Results Overview
An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
414 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-04-02
Participant Flow
17 subjects excluded post-operatively
Participant milestones
| Measure |
Group 1
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
272
|
|
Overall Study
COMPLETED
|
142
|
272
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
Baseline characteristics by cohort
| Measure |
Group 1
n=142 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=272 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
56.47 years
STANDARD_DEVIATION 14.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
32 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The mITT population consisted of 397 patients (414 patients in the Safety group minus 17 subjects excluded post-operatively).
An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.
Outcome measures
| Measure |
Group 1
n=137 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=260 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Subjects Fused at 24 Weeks (as Determined by CT Assessment)
|
85 Participants
|
159 Participants
|
SECONDARY outcome
Timeframe: 24 and 52 WeeksPopulation: Analysis conducted on patients at 24 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). 1. Clinically significant improvement: ≥20mm decrease from baseline 2. Detectable improvement: 10-20mm decrease from baseline 3. Maintained: \<10mm decrease from baseline and \<10mm increase from baseline 4. Deteriorated: \>10mm increase from baseline
Outcome measures
| Measure |
Group 1
n=118 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=219 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Pain on Weight Bearing
Clinically Significant Improvement at 24 weeks
|
87 Participants
|
167 Participants
|
|
Pain on Weight Bearing
Detectable Improvement at 24 weeks
|
12 Participants
|
14 Participants
|
|
Pain on Weight Bearing
Maintained at 24 weeks
|
12 Participants
|
25 Participants
|
|
Pain on Weight Bearing
Deteriorated at 24 weeks
|
6 Participants
|
13 Participants
|
|
Pain on Weight Bearing
Clinically Significant Improvement at 52 weeks
|
95 Participants
|
170 Participants
|
|
Pain on Weight Bearing
Detectable Improvement at 52 weeks
|
8 Participants
|
20 Participants
|
|
Pain on Weight Bearing
Maintained at 52 weeks
|
11 Participants
|
19 Participants
|
|
Pain on Weight Bearing
Deteriorated at 52 weeks
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 and 52 weeksPopulation: Analysis conducted on patients at 24 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). 1. Clinically significant improvement: ≥20mm decrease from baseline 2. Detectable improvement: 10-20mm decrease from baseline 3. Maintained: \<10mm decrease from baseline and \<10mm increase from baseline 4. Deteriorated: \>10mm increase from baseline
Outcome measures
| Measure |
Group 1
n=120 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=223 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Pain at Fusion Site
Clinically Significant Improvement at 24 weeks
|
71 Participants
|
144 Participants
|
|
Pain at Fusion Site
Detectable Improvement at 24 weeks
|
15 Participants
|
20 Participants
|
|
Pain at Fusion Site
Maintained at 24 weeks
|
21 Participants
|
39 Participants
|
|
Pain at Fusion Site
Deteriorated at 24 weeks
|
10 Participants
|
20 Participants
|
|
Pain at Fusion Site
Clinically Significant Improvement at 52 weeks
|
81 Participants
|
139 Participants
|
|
Pain at Fusion Site
Detectable Improvement at 52 weeks
|
11 Participants
|
27 Participants
|
|
Pain at Fusion Site
Maintained at 52 weeks
|
19 Participants
|
44 Participants
|
|
Pain at Fusion Site
Deteriorated at 52 weeks
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 and 52 weeksPopulation: Analysis conducted on patients at 24 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. 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. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment. 1. Clinically significant improvement: ≥10 point decrease from baseline 2. Improved: 5-10 point decrease from baseline 3. Maintained: \<5 point decrease from baseline and \<5 point increase from baseline 4. Deteriorated: \>5 point increase from baseline
Outcome measures
| Measure |
Group 1
n=133 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=249 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Foot Function Index (FFI)
Clinically Significant Improvement at 24 weeks
|
106 Participants
|
190 Participants
|
|
Foot Function Index (FFI)
Improved at 24 weeks
|
4 Participants
|
19 Participants
|
|
Foot Function Index (FFI)
Maintained at 24 weeks
|
14 Participants
|
16 Participants
|
|
Foot Function Index (FFI)
Deteriorated at 24 weeks
|
9 Participants
|
24 Participants
|
|
Foot Function Index (FFI)
Clinically Significant Improvement at 52 weeks
|
114 Participants
|
209 Participants
|
|
Foot Function Index (FFI)
Improved at 52 weeks
|
1 Participants
|
8 Participants
|
|
Foot Function Index (FFI)
Maintained at 52 weeks
|
12 Participants
|
12 Participants
|
|
Foot Function Index (FFI)
Deteriorated at 52 weeks
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 and 52 weeksPopulation: Analysis conducted on patients at 24 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. 1. Clinically significant improvement: ≥20 point increase from baseline 2. Improved: 10-20 point increase from baseline 3. Maintained: \<10 point increase from baseline and \<10 point decrease from baseline 4. Deteriorated: \>10 point decrease from baseline
Outcome measures
| Measure |
Group 1
n=133 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=249 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
AOFAS Hindfoot and Ankle Score
Clinically Significant Improvement at 24 weeks
|
94 Participants
|
180 Participants
|
|
AOFAS Hindfoot and Ankle Score
Improved at 24 weeks
|
19 Participants
|
27 Participants
|
|
AOFAS Hindfoot and Ankle Score
Maintained at 24 weeks
|
14 Participants
|
35 Participants
|
|
AOFAS Hindfoot and Ankle Score
Deteriorated at 24 weeks
|
6 Participants
|
8 Participants
|
|
AOFAS Hindfoot and Ankle Score
Clinically Significant Improvement at 52 weeks
|
106 Participants
|
195 Participants
|
|
AOFAS Hindfoot and Ankle Score
Improved at 52 weeks
|
10 Participants
|
22 Participants
|
|
AOFAS Hindfoot and Ankle Score
Maintained at 52 weeks
|
11 Participants
|
19 Participants
|
|
AOFAS Hindfoot and Ankle Score
Deteriorated at 52 weeks
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 and 52 weeksPopulation: Analysis conducted on patients at 24 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. 1. Maintenance or improvement: ≥0 point increase from baseline 2. Slight Decline: 0-10 point decrease from baseline 3. Deteriorated: \>10 point decrease from baseline
Outcome measures
| Measure |
Group 1
n=133 Participants
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=249 Participants
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
SF-12 Physical Component Score
Maintenance or Improvement at 24 weeks
|
106 Participants
|
203 Participants
|
|
SF-12 Physical Component Score
Slight Decline at 24 weeks
|
22 Participants
|
38 Participants
|
|
SF-12 Physical Component Score
Deteriorated at 24 weeks
|
5 Participants
|
8 Participants
|
|
SF-12 Physical Component Score
Maintenance or Improvement at 52 weeks
|
117 Participants
|
206 Participants
|
|
SF-12 Physical Component Score
Slight Decline at 52 weeks
|
14 Participants
|
33 Participants
|
|
SF-12 Physical Component Score
Deteriorated at 52 weeks
|
1 Participants
|
2 Participants
|
Adverse Events
Group 1
Serious events: 21 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 2
Serious events: 28 serious events
Other events: 100 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1
n=142 participants at risk
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=272 participants at risk
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.1%
3/142 • Number of events 4 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Cardiac disorders
Myocardial infarction
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Congenital, familial and genetic disorders
Congenital foot malformation
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
2/142 • Number of events 2 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.74%
2/272 • Number of events 3 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Gastrointestinal disorders
Megacolon
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Chest pain
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Impaired healing
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.74%
2/272 • Number of events 2 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Not -cardiac chest pain
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
Pyrexia
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
General disorders
cardiac chest pain
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Infection
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Osteomyelitis
|
1.4%
2/142 • Number of events 2 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.74%
2/272 • Number of events 2 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Postoperative wound infection
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Infections and infestations
Staphylococcal infection
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Device related infection
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Postoperative wound infection
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Wound infection staphylococcal
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Investigations
Prothrombin level abnormal
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.74%
2/272 • Number of events 2 • 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
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.70%
1/142 • Number of events 2 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Surgical and medical procedures
Osteotomy
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Aortic steonsis
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.00%
0/272 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Deep vein thrombosis
|
2.1%
3/142 • Number of events 3 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.5%
4/272 • Number of events 4 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Pulmonary embolism
|
0.70%
1/142 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.1%
3/272 • Number of events 3 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
0.37%
1/272 • Number of events 1 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/142 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
1.1%
3/272 • Number of events 3 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
Other adverse events
| Measure |
Group 1
n=142 participants at risk
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
|
Group 2
n=272 participants at risk
Standard Rigid Fixation plus Augment® Bone Graft
|
|---|---|---|
|
Injury, poisoning and procedural complications
Medical device pain
|
4.9%
7/142 • Number of events 7 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
5.1%
14/272 • Number of events 14 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
15/142 • Number of events 17 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
14.0%
38/272 • Number of events 46 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.8%
21/142 • Number of events 24 • Patients were assessed through study completion scheduled at 52 weeks following surgery.
|
17.6%
48/272 • Number of events 56 • 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