CTRI/2014/09/005055
Completed
Phase 4
Prospective, Multi-centre Outcomes Study of Persona® Knee System in Total Knee Arthroplasty
Zimmer India Private Ltd0 sites344 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: null- Patients who require primary Total Knee Arthroplasty using the Persona fixed bearing knee system.Health Condition 3: M171- Unilateral primary osteoarthritisof knee
- Sponsor
- Zimmer India Private Ltd
- Enrollment
- 344
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient must meet the following criteria to be eligible for participation:
- •1\. Age 18 to 80 years old, inclusive.
- •2\. Qualifies for a primary TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- •a) Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- •b) Collagen disorders and/or avascular necrosis of the femoral condyle.
- •c) Post\-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- •d) Moderate valgus, varus, or flexion deformities.
- •e) The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
- •3\. Participated in a study\-related informed consent process.
- •4\. Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
Exclusion Criteria
- •A patient must not meet the following criteria to be eligible for participation:
- •1\. Currently participating in any other surgical intervention studies or pain management studies
- •2\. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
- •3\. Insufficient bone stock on femoral or tibial surfaces.
- •4\. Skeletal immaturity.
- •5\. Neuropathic arthropathy.
- •6\. Any loss of musculature or neuromuscular disease that compromises the affected limb.
- •7\. Stable, painless arthrodesis in a satisfactory functional position.
- •8\. Severe instability secondary to the absence of collateral ligament integrity.
- •9\. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
Outcomes
Primary Outcomes
Not specified
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