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 |
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.
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.
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