Osteoarthritis
Conditions
Brief summary
The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.
Detailed description
The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.
Interventions
DEVICETotal knee replacement with NexGen CR knee prosthesis
comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis
DEVICETotal knee replacement(TKR) with Nexgen CR-flex
TKR using Nexgen CR-flex implant
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties
Exclusion criteria
* inflammatory arthritis * osteoarthritis of the hip causing pain or restricted mobility * a foot or ankle disorder which limited walking * dementia or a neurological disorder including a past history of stroke which affected mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Society Knee Score | baseline and 3 years | change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NexGen CR and CR-flex Knee Prosthesis The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | NexGen CR and CR-flex Knee Prosthesis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age Continuous | 69.7 years STANDARD_DEVIATION 6.43 |
| Region of Enrollment Korea, Republic of | 54 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Change in Knee Society Knee Score
change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome. Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points
Time frame: baseline and 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High-Flexion Posterior Cruciate Retaining TKA | Change in Knee Society Knee Score | 93.9 scores on a scale | Standard Deviation 4.66 |
| High-Flexion Posterior Cruciate Scrificing TKA | Change in Knee Society Knee Score | 93.7 scores on a scale | Standard Deviation 4.53 |