Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study (NCT03391323) | Clinical Trial Compass
CompletedNot Applicable
Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study
United States218 participantsStarted 2015-04
Plain-language summary
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.
Who can participate
Age range21 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Patient…
What they're measuring
1
Forgotten Joint Score (FJS)
Timeframe: Change from baseline at 2 years and 5 years post-operative