Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study

David F. Scott, MD

Status

Completed

Conditions

Joint Disease

Osteoarthritis

Osteoarthritis, Knee

Treatments

Device: Medacta GMK PS Posterior Stabilized Knee Prosthesis

Device: Medacta GMK Sphere® Medial-Pivot Knee Prosthesis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03391323

SJRC-GMK

Details and patient eligibility

About

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.

Enrollment

218 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 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.
Patients that are prisoners.