Trial Outcomes & Findings for Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty (NCT NCT02067533)
NCT ID: NCT02067533
Last Updated: 2015-05-12
Results Overview
in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
1 year after total knee arthroplasty
Results posted on
2015-05-12
Participant Flow
Participant milestones
| Measure |
Flexion Position
soft tissue repair in flexion position
|
Extension Position
soft tissue repair in extension position
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
46
|
|
Overall Study
COMPLETED
|
41
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Flexion Position
soft tissue repair in flexion position
|
Extension Position
soft tissue repair in extension position
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Flexion Position
n=45 Participants
soft tissue repair in flexion position
|
Extension Position
n=46 Participants
soft tissue repair in extension position
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
67.14 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year after total knee arthroplastyin all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.
Outcome measures
| Measure |
Flexion Position
n=41 Participants
soft tissue repair in flexion position
|
Extension Position
n=44 Participants
soft tissue repair in extension position
|
|---|---|---|
|
Knee Range of Motion (ROM)
|
119 degree
Standard Deviation 6.8
|
120 degree
Standard Deviation 5.4
|
Adverse Events
Flexion Position
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extension Position
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