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

Osteoarthritis Clinical Trial

Official title:

Medacta GMK Sphere® Medial-Pivot, Cruciate Substituting vs. Medacta GMK PS Posterior Stabilized Kne vs. OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03391323
• Other study ID #: SJRC-GMK
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Spokane Joint Replacement Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Medacta GMK Sphere® Medial-Pivot Knee Prosthesis

• Medacta GMK PS Posterior Stabilized Knee Prosthesis

Locations

Country	Name	City	State
United States	Spokane Joint Replacement Center	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
David F. Scott, MD	Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forgotten Joint Score (FJS)	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.	Change from baseline at 2 years and 5 years post-operative
Secondary	Total Knee Society Score (KSS)	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.	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary	Lower Extremity Activity Scale (LEAS)	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.	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary	Radiographic Analysis	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.	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative