Trial Outcomes & Findings for Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant (NCT NCT01717001)
NCT ID: NCT01717001
Last Updated: 2023-10-25
Results Overview
Comparison of amount of flexion achieved by the knee between the two arms
Recruitment status
COMPLETED
Target enrollment
66 participants
Primary outcome timeframe
at least 6 months post-surgery
Results posted on
2023-10-25
Participant Flow
Participant milestones
| Measure |
ConforMIS
Patients with ConforMIS implants
|
Standard Total Knee Implant
Patients implanted with standard total knee implant
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
28
|
|
Overall Study
COMPLETED
|
32
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not accessible and not used for analysis
Baseline characteristics by cohort
| Measure |
ConforMIS
n=24 Participants
Patients with ConforMIS implants
|
Standard Total Knee Implant
n=14 Participants
Patients implanted with standard total knee implant
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 7.7 • n=24 Participants
|
66.7 years
STANDARD_DEVIATION 5.7 • n=14 Participants
|
62.6 years
STANDARD_DEVIATION 7.6 • n=38 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
Data not accessible and not used for analysis
|
0 Participants
Data not accessible and not used for analysis
|
0 Participants
Data not accessible and not used for analysis
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
14 participants
n=14 Participants
|
38 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: at least 6 months post-surgeryComparison of amount of flexion achieved by the knee between the two arms
Outcome measures
| Measure |
ConforMIS
n=24 Participants
Patients with ConforMIS implants
|
Standard Total Knee Implant
n=14 Participants
Patients implanted with standard total knee implant
|
|---|---|---|
|
Post-operative Range of Motion
|
103.8 degrees
Standard Deviation 14.7
|
95.8 degrees
Standard Deviation 21.2
|
Adverse Events
ConforMIS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Total Knee Implant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place