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



Status:Recruiting
Conditions:Arthritis, Arthritis, Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:21 - 80
Updated:1/7/2018
Start Date:April 2015
End Date:December 2023
Contact:David Scott, MD
Email:dfscott@mac.com
Phone:509-466-6393

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Medacta GMK Sphere® Medial-Pivot, Cruciate Substituting vs. Medacta GMK PS Posterior Stabilized Kne vs. OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study

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.


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.
We found this trial at
1
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Spokane, Washington 99218
Phone: 509-466-6393
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