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

Not Applicable

Completed

• Conditions: Joint Disease; Osteoarthritis; Osteoarthritis, Knee
• Interventions: Device: Medacta GMK Sphere® Medial-Pivot Knee Prosthesis; Device: Medacta GMK PS Posterior Stabilized Knee Prosthesis

• Registration Number: NCT03391323
• Lead Sponsor: David F. Scott, MD

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 similar study design.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-05
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medacta GMK Sphere® Medial-Pivot Knee Prosthesis	Medacta GMK Sphere® Medial-Pivot Knee Prosthesis	-
Medacta GMK PS Posterior Stabilized Knee Prosthesis	Medacta GMK PS Posterior Stabilized Knee Prosthesis	-

Primary Outcome Measures

Name	Time	Method
Forgotten Joint Score (FJS)	Change from baseline at 2 years and 5 years post-operative	The average Forgotten Joint Score (FJS) of those patients receiving the Medacta GMK Sphere® knee prosthesis will be compared with the average FJS of those receiving the Medacta GMK PS knee prosthesis.; The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness.

Secondary Outcome Measures

Name	Time	Method
Radiographic Analysis	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative	Radiographs will be assessed for radiolucency, migration and subsidence. An AP Longstanding view will be obtained pre-operatively, and at 6 weeks and 1 year post-operatively to determine degree of Varus or Valgus.
Total Knee Society Score (KSS)	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative	Clinical outcomes will be evaluated via the Knee Society Score (KSS). The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs. Both scores range from 0-100, with a higher score indicating a better outcome.
Lower Extremity Activity Scale (LEAS)	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative	Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS). The LEAS scale range is 1-18, with a higher value indicating a higher level of activity.

Trial Locations

Locations (1)

Spokane Joint Replacement Center; 🇺🇸 Spokane, Washington, United States