Trial Outcomes & Findings for Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings (NCT NCT00417859)
NCT ID: NCT00417859
Last Updated: 2020-04-21
Results Overview
distance in meters of gait stride lenght measured by a data logger with five inertial sensors
COMPLETED
NA
64 participants
5years
2020-04-21
Participant Flow
8 patients were excluded
Participant milestones
| Measure |
TKA Mobile
TKA mobile
Total knee arthroplasty with mobile bearing implant.
|
TKA Fix
Total knee arthroplasty with fixed bearing implant.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
30
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Baseline characteristics by cohort
| Measure |
TKA Mobile
n=26 Participants
TKA mobile
Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing
|
TKA Fix
n=30 Participants
TKA fix
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
70.2 years
STANDARD_DEVIATION 7.1 • n=41 Participants
|
68.7 years
STANDARD_DEVIATION 7.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 5yearsdistance in meters of gait stride lenght measured by a data logger with five inertial sensors
Outcome measures
| Measure |
Preoperative
n=26 Participants
preoperative stride lenght of all participants
|
5 Years
n=29 Participants
stride lenght at 1 year following TKA of all participants
|
|---|---|---|
|
Gait Stride Length
|
1.2 meters
Interval 1.1 to 1.3
|
1.2 meters
Interval 1.1 to 1.3
|
PRIMARY outcome
Timeframe: 5yearsPopulation: data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)
The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time.
Outcome measures
| Measure |
Preoperative
n=25 Participants
preoperative stride lenght of all participants
|
5 Years
n=25 Participants
stride lenght at 1 year following TKA of all participants
|
|---|---|---|
|
EuroQoL Quality of Life Scale (EQ-5D)
|
75.3 score on a scale
Standard Deviation 17.5
|
79.9 score on a scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: 5yearsPopulation: data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)
Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Outcome measures
| Measure |
Preoperative
n=25 Participants
preoperative stride lenght of all participants
|
5 Years
n=25 Participants
stride lenght at 1 year following TKA of all participants
|
|---|---|---|
|
Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures
|
51.7 score on a scale
Standard Deviation 12.8
|
49.3 score on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 5yearscount of numbers of dislocated implants.
Outcome measures
| Measure |
Preoperative
n=26 Participants
preoperative stride lenght of all participants
|
5 Years
n=29 Participants
stride lenght at 1 year following TKA of all participants
|
|---|---|---|
|
Number of Participants With Dislocation
|
0 Participants
|
0 Participants
|
Adverse Events
TKA Mobile
TKA Fix
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TKA Mobile
n=25 participants at risk
TKA mobile
Total knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing
|
TKA Fix
n=25 participants at risk
TKA fix
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
postoperative varus knee laxity due to a deficiency in the fibular collateral ligament
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place