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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2023-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis Osteoarthritis, Knee Joint Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Medacta GMK Sphere® Medial-Pivot Knee Prosthesis

Group Type OTHER

Medacta GMK Sphere® Medial-Pivot Knee Prosthesis

Intervention Type DEVICE

Medacta GMK PS Posterior Stabilized Knee Prosthesis

Group Type OTHER

Medacta GMK PS Posterior Stabilized Knee Prosthesis

Intervention Type DEVICE

Interventions

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Medacta GMK Sphere® Medial-Pivot Knee Prosthesis

Intervention Type DEVICE

Medacta GMK PS Posterior Stabilized Knee Prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes