N/A
N=331
A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
Total Knee Arthroplasty · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00763386 ↗Enrolled (actual)
331
Serious AEs
9.7%
Results posted
May 2012
Primary outcome: Primary: Postoperative Range of Motion (ROM) — 102.3; 106.8; 117.6; 118.2 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NexGen LPS-Flex Fixed Bearing Knee (Device); NexGen Legacy Posterior Stabilized Knee (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Range of Motion (ROM) |
102.3; 106.8; 117.6; 118.2; 120.3; 121.7 | — |
| SECONDARY Return to Function (RtF) Via Knee Society Score (Modified) |
56.4; 58.5; 79.2; 79.7; 81.1; 81.7 | — |
Summary
The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.
Eligibility Criteria
Inclusion Criteria
- Age, 21-80 years
- Sex, Males and females will be included
- BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
- Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
- Patient is willing and able to cooperate in follow-up therapy.
- Patient exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
- Patient has stable and functional 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 90 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 (NCT00763386). 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.