Medacta GMK Sphere® Multicenter Post-Market Outcomes Study
Key facts
- Where
- Austin, Chicago, New Orleans, Oklahoma City, and Spokane, United StatesSee the 5 sites
Where in United States
- Texas OrthopedicsAustin, United StatesNo longer taking part
- Norhtwestern UniversityChicago, United StatesNo longer taking part
- Tulane UniversityNew Orleans, United StatesNo longer taking part
- McBride Orthopedic HospitalOklahoma City, United StatesNo longer taking part
- Spokane Joint Replacement CenterSpokane, United StatesNo longer taking part
Trial details
- Who runs it
- Medacta USA
- Trial code
- NCT02501733
- Record updated
- 25 September 2025
- Original description
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.Read full original descriptionShow less
Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study
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.
Inclusion: 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: Patients that are immunologically compromised, or receiving chronic steroids (> 30 days); Patients with a history of total or unicompartmental reconstruction of the affected joint; Patients with a systemic or metabolic disorder leading to progressive bone deterioration; Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis; Patients with an active or suspected latent infection in or about the knee joint; Patients with inflammatory arthritis; Patients that are morbidly obese, body mass index (BMI) > 40; 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 knee fusion to the affected joint; Patients that are prisoners.