Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Medacta

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Medacta GMK Sphere® Medial Knee Prosthesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT02501733

121416-01

Details and patient eligibility

About

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.

Enrollment

260 patients

Sex

All

Ages

21 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.