Medacta GMK Sphere® Multicenter Post-Market Outcomes Study
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 21 - 80 |
Updated: | 3/8/2019 |
Start Date: | June 2015 |
End Date: | December 2023 |
Contact: | Mukesh Ahuja, MBBS, MS |
Email: | Mahuja@medacta.us.com |
Phone: | 312-548-9968 |
Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study
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.
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.
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.
We found this trial at
4
sites
Chicago, Illinois 60611
Principal Investigator: David Manning, MD
Phone: 312-695-1441
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Austin, Texas 78751
Principal Investigator: David Dodgin, MD
Phone: 512-476-2830
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Austin, Texas 78759
Principal Investigator: Tyler Goldberg, MD
Phone: 512-439-1001
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Spokane, Washington 99218
Principal Investigator: David F Scott, MD
Phone: 509-466-6393
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