Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.

Key facts

Study ID: NCT02501733
Run by: Medacta USA
People needed: 260
Starts: 2015-06-01
Expected to finish: 2024-12-05
Last updated by the study team: 2025-09-25

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 that have had a high tibial osteotomy or femoral osteotomy.
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).
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 that are prisoners.

Where it is running

Norhtwestern University — Chicago, Illinois, United States
Tulane University — New Orleans, Louisiana, United States
McBride Orthopedic Hospital — Oklahoma City, Oklahoma, United States
Texas Orthopedics — Austin, Texas, United States
Spokane Joint Replacement Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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