CompletedNot Applicable

Safety and Efficacy of the Oxford Cementless Partial Knee System

United States320 participantsStarted 2011-12

Plain-language summary

The objective of this clinical investigation is to evaluate the safety and effectiveness of the Oxford® Cementless Partial Knee System. The Oxford® Cementless Partial Knee System is intended to help the patients diagnosed with osteoarthritis or avascular necrosis gain mobility and decrease pain. All of the risks common to a conventional joint replacement are possible with this device as certain risks are associated with any invasive procedures. The study is designed to document and compare the clinical and radiographic results of the Oxford® Cementless Partial Knee System to those of the cemented Oxford® Partial Knee System (control treatment).

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a preoperative Knee Society Assessment Score of \<70 * Patients undergoing primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise * Patients diagnosed with osteoarthritis or avascular necrosis limited to the medial compartment of the operative knee joint * Male or female patients who are at least 21 years of age at the time of surgery * Patients with full thickness cartilage loss, with or without bone loss in the medial compartment * Patients with functionally intact Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) * Patients who needs to obtain relief of pain and/or improved function in their knee * Patients with fixed flexion deformity \<15 degrees * Patients who are able to follow postoperative care instructions * Patients who are willing and able to return for scheduled follow-up evaluations * Patients in which natural alignment can be restored * Patients who have completed a valid, Institutional Review Board (IRB) approved Informed Consent Form * Patients with child-bearing potential who voluntarily agree to prevent pregnancy for 2 years following device implantation Exclusion Criteria: * Patients with a preoperative Knee Society Assessment Score of greater than or equal to 70 * Patients in which the device would be used to revise a failed prosthesis * Patients who are less than 21 years of age, at the time of surgery * Disease or damage to the latera…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic Success

Timeframe: 2 years

Absence of Revision/Removal/Unanticipated Adverse Device Effect (UADE)

Timeframe: 2 Years

The Knee Society Assessment Score

Timeframe: 2 Years

The Knee Society Function Score

Timeframe: 2 Year

Trial details

NCT IDNCT01473134

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-30

Results submitted2024-02-06

View on ClinicalTrials.gov More Osteoarthritis, Knee trials