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Completed

NCT Number: NCT02350049

Cementless Oxford Partial Knee Controlled Observational Study

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 22+months

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

Secondary outcomes

  1. Survivorship (Cementless Only)

    Time frame: 22+ Months

    Minimum 1,000 cases to assess survivorship of cementless components

  2. American Knee Society Score

    Time frame: 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

    Time frame: 0-16 Weeks, 6 Months, 12 Months, 22+ Months

    Retrospective study; data will be collected if available.

  4. Adverse Events

    Time frame: Through 22+ Months Postop

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Cementless Oxford Partial Knee Retrospective and Prospective Controlled Multi-center Observational Study

Acronym: GK10

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 29, 2015
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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