CompletedNot Applicable

NexGen TM Tibia Clinical Outcomes Study

United States160 participantsStarted 2017-10-03

Plain-language summary

The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is at least 18 years of age.
✓. Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
✓. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
✓. Collagen disorders and/or avascular necrosis of the femoral condyle.
✓. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
✓. Moderate valgus, varus, or flexion deformities.
✓. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
✓. Patient has participated in the study-related Informed Consent process.

Exclusion criteria

✕. Previous history of infection in the affected joint.
✕. Active local or 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 ligament integrity.

What they're measuring

Radiograph Assessment of Progressive Tibial Radiolucencies

Timeframe: 2 years

Trial details

NCT IDNCT03272373

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-30

Results submitted2024-11-12

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