Trial Outcomes & Findings for Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System (NCT NCT00740376)
NCT ID: NCT00740376
Last Updated: 2019-06-13
Results Overview
CCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines \>1mm in \>50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) \> 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations \> 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Month 24 postoperative
Results posted on
2019-06-13
Participant Flow
Unit of analysis: Implants
Participant milestones
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Overall Study
STARTED
|
22 26
|
15 21
|
|
Overall Study
COMPLETED
|
19 22
|
12 18
|
|
Overall Study
NOT COMPLETED
|
3 4
|
3 3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System
Baseline characteristics by cohort
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=26 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=21 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
Total
n=47 Implants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.42 years
n=63 Implants
|
57.48 years
n=85 Implants
|
58.95 years
n=148 Implants
|
|
Sex: Female, Male
Female
|
18 Implants
n=63 Implants
|
7 Implants
n=85 Implants
|
25 Implants
n=148 Implants
|
|
Sex: Female, Male
Male
|
8 Implants
n=63 Implants
|
14 Implants
n=85 Implants
|
22 Implants
n=148 Implants
|
|
Region of Enrollment
United States
|
26 Implants
n=63 Implants
|
21 Implants
n=85 Implants
|
47 Implants
n=148 Implants
|
PRIMARY outcome
Timeframe: Month 24 postoperativeCCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines \>1mm in \>50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) \> 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations \> 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery.
Outcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=22 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=18 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.
|
17 Implants
|
15 Implants
|
SECONDARY outcome
Timeframe: Month 24 postoperativeAmerican Knee Society Score (AKSS) Total Score - Range: 0 (worst) - 100 (best) Pain Score - Range: 0 (worst) - 50 (best) Function Score - Range: 0 (worst) - 100 (best)
Outcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=20 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=19 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
American Knee Society Score (AKSS) (Total, Pain & Function Scores)
Mean Total Score
|
94.53 score on a scale
Standard Deviation 8.46
|
89.58 score on a scale
Standard Deviation 12.87
|
|
American Knee Society Score (AKSS) (Total, Pain & Function Scores)
Mean Pain Score
|
48.00 score on a scale
Standard Deviation 6.77
|
42.63 score on a scale
Standard Deviation 10.32
|
|
American Knee Society Score (AKSS) (Total, Pain & Function Scores)
Mean Function Score
|
95.50 score on a scale
Standard Deviation 10.50
|
94.74 score on a scale
Standard Deviation 11.72
|
SECONDARY outcome
Timeframe: Month 24 postoperativeHSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best)
Outcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=20 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=19 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)
Mean Pain Score
|
29.25 score on a scale
Standard Deviation 2.45
|
28.16 score on a scale
Standard Deviation 3.80
|
|
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)
Mean Total Score
|
95.25 score on a scale
Standard Deviation 5.31
|
93.63 score on a scale
Standard Deviation 6.18
|
|
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)
Mean Function Score
|
21.30 score on a scale
Standard Deviation 1.78
|
20.79 score on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Month 24 postoperativeKnee injury and Osteoarthritis Outcome Score (pain): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (symptoms): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (activities of daily living (ADL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport/rec): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life (QOL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport and recreation): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life): 0 (worst) - 100 (best)
Outcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=17 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=12 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Mean Sport/Rec Score
|
77.94 score on a scale
Standard Deviation 21.22
|
78.67 score on a scale
Standard Deviation 21.17
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Mean QOL Score
|
83.94 score on a scale
Standard Deviation 15.11
|
84.27 score on a scale
Standard Deviation 13.26
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Mean Pain Score
|
91.35 score on a scale
Standard Deviation 11.15
|
92.00 score on a scale
Standard Deviation 9.71
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Mean Symptoms Score
|
63.82 score on a scale
Standard Deviation 13.87
|
66.73 score on a scale
Standard Deviation 15.54
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Mean ADL Score
|
93.65 score on a scale
Standard Deviation 10.21
|
92.67 score on a scale
Standard Deviation 9.80
|
SECONDARY outcome
Timeframe: Month 24 postoperativeKaplan-Meier survival curves will be plotted for All Enrolled investigational devices and All Enrolled control devices on the same graph to facilitate graphical comparisons of survivorship over time.
Outcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=26 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=21 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Survival Rate Using Kaplan-Meier Survival Curves
|
24 Implants
|
21 Implants
|
SECONDARY outcome
Timeframe: Month 24 postoperativeOutcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=26 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=21 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Number of Implants With Any Device-related Complications
|
3 Implants
|
0 Implants
|
SECONDARY outcome
Timeframe: Month 24 postoperativeFor both the Tibial \& Femoral Components the following were recorded: Implant Subsidence \> 2mm (recorded for the tibial component only) Implant Loosening \> 2deg Radiolucent Line (RLL) in \>50% zones Progressive RLL Osteolysis ≥ 5mm
Outcome measures
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=20 Implants
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=18 Implants
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Tibial Implant Subsidence
|
0 Implants
|
0 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Tibial Implant Loosening
|
0 Implants
|
0 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Tibial RLL
|
1 Implants
|
1 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Tibial Progressive RLL
|
3 Implants
|
1 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Tibial Osteolysis
|
1 Implants
|
0 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Femoral Implant Loosening
|
0 Implants
|
0 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Femoral RLL
|
0 Implants
|
1 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Femoral Progressive RL
|
0 Implants
|
1 Implants
|
|
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Femoral Osteolysis
|
0 Implants
|
0 Implants
|
Adverse Events
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=22 participants at risk
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=15 participants at risk
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukaemia anemia
|
4.5%
1/22
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia progression
|
4.5%
1/22
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.5%
1/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Contralateral hip arthrotomy for loose body removal
|
4.5%
1/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Contralateral UKR
|
4.5%
1/22
|
0.00%
0/5
|
|
Surgical and medical procedures
Contralateral TKR
|
9.1%
2/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Closed reduction percutaneous screw fixation of ipsilateral subcapital femoral neck fracture
|
4.5%
1/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Revision for meniscal bearing dislocation
|
4.5%
1/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Revision for periprosthetic fracture
|
4.5%
1/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Carpal tunnel release surgery
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Contralateral knee hematoma drainage
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Contralateral knee traumatic wound dehiscence
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Gastrointestinal polyp removal
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Knee hematoma drainage (operative side)
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.00%
0/22
|
6.7%
1/15
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/22
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Traumatic knee-wound dehiscence (operative side)
|
0.00%
0/22
|
6.7%
1/15
|
Other adverse events
| Measure |
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
n=22 participants at risk
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).
|
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
n=15 participants at risk
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Achiness and sensitivity both knees
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Acute post-op blood loss anemia
|
13.6%
3/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Ankle swelling
|
4.5%
1/22
|
0.00%
0/15
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
4.5%
1/22
|
0.00%
0/15
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22
|
26.7%
4/15
|
|
Surgical and medical procedures
Contralateral hallux rigidus surgery
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Contralateral hip OA
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Contralateral hip pain
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Contralateral knee crepitus
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Contralateral knee OA
|
4.5%
1/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Contralateral knee pain
|
4.5%
1/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Contralateral meniscus tear
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Contralateral twisted knee
|
4.5%
1/22
|
0.00%
0/15
|
|
Surgical and medical procedures
Drainage from incision
|
4.5%
1/22
|
0.00%
0/15
|
|
Infections and infestations
Fever
|
9.1%
2/22
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gas pain
|
4.5%
1/22
|
0.00%
0/15
|
|
Gastrointestinal disorders
Heartburn
|
4.5%
1/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Heterotopic ossification (operative side)
|
4.5%
1/22
|
0.00%
0/15
|
|
Gastrointestinal disorders
Indigestion
|
4.5%
1/22
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Itching
|
9.1%
2/22
|
13.3%
2/15
|
|
Musculoskeletal and connective tissue disorders
Knee and ankle swelling (operative side)
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Knee crepitus (operative side)
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Knee pain (operative side)
|
9.1%
2/22
|
13.3%
2/15
|
|
Injury, poisoning and procedural complications
Knee swelling and discomfort (operative side)
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Left elbow and head bruising
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
18.2%
4/22
|
13.3%
2/15
|
|
Gastrointestinal disorders
Nausea
|
31.8%
7/22
|
46.7%
7/15
|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/22
|
6.7%
1/15
|
|
Nervous system disorders
Numbness and tingling
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Off-label drill bit breakage during surgery
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Pes anserine bursitis (operative side)
|
9.1%
2/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Post-fall bruised knee (operative side)
|
4.5%
1/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Post-fall contralateral knee pain
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post-fall knee contusion (operative side)
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post-fall knee pain (operative side)
|
13.6%
3/22
|
6.7%
1/15
|
|
Infections and infestations
Productive cough with yellow discharge
|
4.5%
1/22
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash on back and chest
|
4.5%
1/22
|
0.00%
0/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer (left shin)
|
4.5%
1/22
|
0.00%
0/15
|
|
General disorders
Sleeplessness
|
13.6%
3/22
|
0.00%
0/15
|
|
Infections and infestations
Sore throat
|
4.5%
1/22
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Total hysterectomy
|
4.5%
1/22
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Twisted knee (operative side)
|
4.5%
1/22
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Uncharacteristic pain (operative side)
|
4.5%
1/22
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
All over general itching
|
0.00%
0/22
|
6.7%
1/15
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
C-6 calcification
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Contralateral knee arthroscopy
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Contralateral pes anserine bursitis
|
0.00%
0/22
|
6.7%
1/15
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Early degenerative changes in lumbar spine
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Elbow pain
|
0.00%
0/22
|
6.7%
1/15
|
|
Cardiac disorders
Elevated blood pressure
|
0.00%
0/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Fractured foot
|
0.00%
0/22
|
6.7%
1/15
|
|
Cardiac disorders
Hypertension
|
0.00%
0/22
|
6.7%
1/15
|
|
General disorders
Insomnia
|
0.00%
0/22
|
26.7%
4/15
|
|
Musculoskeletal and connective tissue disorders
Ipsilateral hip bursitis
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Knee arthroscopy (operative side)
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Knee locking (operative side)
|
0.00%
0/22
|
6.7%
1/15
|
|
General disorders
Lethargy
|
0.00%
0/22
|
6.7%
1/15
|
|
Surgical and medical procedures
Mole removal
|
0.00%
0/22
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22
|
6.7%
1/15
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Occasional contralateral intertrochanteric hip pain
|
0.00%
0/22
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Post-fall bruised contralateral knee
|
0.00%
0/22
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Post-op nausea
|
0.00%
0/22
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Progression of OA
|
0.00%
0/22
|
6.7%
1/15
|
|
Gastrointestinal disorders
Vomiting and diarrhea
|
0.00%
0/22
|
13.3%
2/15
|
Additional Information
Global Regulatory Affairs and Clinical Director
Corin
Phone: +44 (0)1285 659866
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60