Spokane, Washington 99218


Purpose:

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.


Criteria:

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 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.


NCT ID:

NCT02501733


Primary Contact:

Study Director
Mukesh Ahuja, MBBS, MS
Medacta USA, Inc.

Mukesh Ahuja, MBBS, MS
Phone: 312-548-9968
Email: Mahuja@medacta.us.com


Backup Contact:

N/A


Location Contact:

Spokane, Washington 99218
United States

David Scott, MD
Phone: 509-466-6393
Email: dfscott@orthospecialtyclinic.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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