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GK10: Cementless Oxford Partial Knee Controlled Observational Study

Sponsor
Zimmer Biomet (Industry)
Overall Status
Completed
CT.gov ID
NCT02350049
Collaborator
(none)
391
Enrollment
29
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    391 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study
    Actual Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    Apr 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Investigational

    Cementless Medial Partial Knee
    Control

    Cemented Medial Partial Knee

    Outcome Measures

    Primary Outcome Measures

    1. Composite Endpoint- Safety & Efficacy (Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects) [22+months]

      Radiographic Success, American Knee Society Score, Absence of Revision / Removal / Unanticipated Adverse Device Affects

    Secondary Outcome Measures

    1. Survivorship (Cementless Only) [22+ Months]

      Minimum 1,000 cases to assess survivorship of cementless components

    2. American Knee Society Score [0-16 Week, 6 Month, 12 Month]

      Assessment of Function and Range of Motion; retrospective study- data will be collected if available

    3. Oxford Knee Score [0-16 Weeks, 6 Months, 12 Months, 22+ Months]

      Retrospective study; data will be collected if available.

    4. Adverse Events [Through 22+ Months Postop]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • have primary diagnosis of osteoarthritis or avascular necrosis limited to the medial compartment of the knee

    • signed informed consent for patients contributing to investigational or control if required

    • Male or female over the age of 21 years at the time of surgery

    • Undergone primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise

    • Patients that are current residents of the United Kingdom

    Exclusion Criteria:

    • Evidence of infection, sepsis, and osteomyelitis at the time of surgery

    • 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

    • Partial or full thickness cartilage disease or damage to central part of the lateral femoral condyle

    • Osteoporosis or insufficient bone stock

    • Metabolic disorders which may impair bone formation

    • Osteomalacia

    • Distant foci of infection 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

    • Refuse to sign informed consent if it is required

    • Patients that are not current residents of the United Kingdom

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zimmer Biomet

    Investigators

    • Principal Investigator: Prof. David Murray, BA Hons, BChir, FRCS, MD, Nuffield Orthopaedic Centre
    • Study Director: Prof. Hemant Pandit, MBBS, MS, DNB, FRCS, DPhil, Nuffield Orthopaedic Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT02350049
    Other Study ID Numbers:
    • ORTHO.CR.GK10
    First Posted:
    Jan 29, 2015
    Last Update Posted:
    Dec 8, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Necrosis

    Study Results

    No Results Posted as of Dec 8, 2017