N/A
N=189
A Study to Compare the NexGen CR and CR-Flex Knee Implants
Total Knee Arthroplasty · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00761956 ↗Enrolled (actual)
189
Serious AEs
1.6%
Results posted
Jul 2012
Primary outcome: Primary: Postoperative Range of Motion (ROM) — 119.1; 120.7 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NexGen CR-Flex Fixed Bearing Knee (Device); NexGen CR Knee (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Range of Motion (ROM) |
119.1; 120.7 | — |
| SECONDARY Return to Function (RtF) Via Knee Scoiety Score (Modified) |
80.9; 85.1 | — |
Summary
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
Eligibility Criteria
Inclusion Criteria
- Age, 21-80 years
- Sex, Male and Females will be included
- BMI less than or equal to 39
- Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
- Patient is willing and able to cooperate in follow-up therapy.
- Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
- Patient has stable and functional posterior cruciate and collateral ligaments.
- Patient has potential to perform higher than average range of motion activities.
- Operative side range of motion flexion greater than or equal to 120 degrees.
- Severe knee pain and disability due to degenerative joint disease.
- Patient or patient's legal representative has signed the Informed Consent form.
Exclusion Criteria
- Previous history of infection in the affected joint.
- Previously failed knee endoprosthesis of any kind.
- Charcot joint disease or other severe neurosensory deficits.
- Previous patellectomy
- Patient is skeletally immature.
- Grossly insufficient femoral or tibial bone stock.
- Patient is pregnant.
- Varus or valgus deformity greater than 20 degrees.
- Fixed flexion deformity greater than 15 degrees.
- Previous high tibial osteotomy.
- Previous femoral osteotomy.
- Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.
- Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.
Data sourced from ClinicalTrials.gov (NCT00761956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.