Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study

Completed · Not applicable

Conditions studied: Osteoarthritis, Osteoarthritis, Knee, Joint Disease

In brief

The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.

Key facts

Study ID

NCT03391323

Run by

David F. Scott, MD

People needed

218

Starts

2015-04-01

Expected to finish

2023-11-27

Last updated by the study team

2026-04-29

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients willing to sign the Informed Consent.
• Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.
• Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery.
• Patients requiring a primary total knee replacement.
• Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
• Patients with intact collateral ligaments.

You may not qualify if…

• Patients with inflammatory arthritis.
• Patients that are morbidly obese, body mass index (BMI) > 40.
• Patients with a history of total or unicompartmental reconstruction of the affected joint.
• Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
• Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers.
• Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
• Patients with knee fusion to the affected joint.
• Patients with an active or suspected latent infection in or about the knee joint.
• Patients whose surgery will utilize computer-assisted surgical navigation (CAOS) techniques.
• Patients whose surgery will utilize minimally invasive surgical techniques.
• Patients that are prisoners.

Where it is running

• Spokane Joint Replacement Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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