N/A
N=266
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Osteoarthritis · Traumatic Arthritis · Avascular Necrosis of the Femoral Condyle · Moderate Varus · Valgus
Bottom Line
View on ClinicalTrials.gov: NCT00854295 ↗Enrolled (actual)
266
Serious AEs
11.3%
Results posted
Feb 2023
Primary outcome: Primary: Group 2 - Total Knee Society Score (KSS) — 92.2; 78.5; 118.2; 96.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NexGen LPS-Flex Mobile Bearing Knee (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Group 2 - Total Knee Society Score (KSS) |
92.2; 78.5; 118.2; 96.7; 148; 130.4 | — |
| PRIMARY Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss |
90; 14 | — |
| PRIMARY Group 2 - Number of Subjects With Absence of Implant Revision |
103; 14 | — |
| PRIMARY Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication |
105; 14 | — |
| PRIMARY Group 1 - Total Knee Society Score (KSS) |
164.6; 184.4; 142.4; 142.6; 161.9; 169.3 | — |
| PRIMARY Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss |
65; 62 | — |
| PRIMARY Group 1 - Number of Subjects With Absence of Implant Revision |
75; 68 | — |
| PRIMARY Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication |
75; 67 | — |
Summary
The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.
Eligibility Criteria
Inclusion Criteria
- Osteoarthritis
- Primary and secondary traumatic arthritis
- Avascular necrosis of the femoral condyle
- Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)
Exclusion Criteria
- Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral integrity
- Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.
- Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up
- Patient is not willing or able to give informed consent to participate in the follow-up program
- Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.
Data sourced from ClinicalTrials.gov (NCT00854295). 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.