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

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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.


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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Spokane, WA
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