Status:
COMPLETED
Oxford Partial Knee Comparative Instrument Pilot Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumen...
Detailed Description
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumen...
Eligibility Criteria
Inclusion
- Outside the United States:
- The Oxford Partial Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement (in the United States). Use of cementless femoral fixation is permitted outside of the United States only (if it complies with all local, state, and/or national and international regulations), however the same technique must be used consistently throughout the course of the study (cemented or cementless).
Exclusion
- The exclusion criteria will include the same contraindications stated in the FDA approved labeling for the device (approved in PMA P010014). These contraindications include:
- Infection, sepsis, and osteomyelitis
- Use in the lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
- Disease or damage to the lateral compartment of the knee
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, neuromuscular disease
- Incomplete or deficient soft tissue surrounding the knee
- Charcot's disease
- A fixed varus deformity (not passively correctable) of greater than 15 degrees
- A flexion deformity greater than 15 degrees
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01410786
Start Date
June 1 2013
End Date
December 1 2015
Last Update
August 2 2017
Active Locations (1)
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1
Leinster Orthopaedic Centre
Christchurch, New Zealand