Status:
COMPLETED
Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study
Lead Sponsor:
David F. Scott, MD
Collaborating Sponsors:
Medacta USA
Conditions:
Osteoarthritis
Osteoarthritis, Knee
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
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 simi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT03391323
Start Date
April 1 2015
End Date
November 27 2023
Last Update
November 13 2024
Active Locations (1)
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1
Spokane Joint Replacement Center
Spokane, Washington, United States, 99218