Clinical trial NCT03391323: Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis, Knee
Joint Disease
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
Collaborators: name: Medacta USA
First posted: 2018-01-05
Enrollment: 218
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Forgotten Joint Score (FJS)
timeFrame: Change from baseline at 2 years and 5 years post-operative
Secondary outcomes:
measure: Total Knee Society Score (KSS)
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
measure: Lower Extremity Activity Scale (LEAS)
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
measure: Radiographic Analysis
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center
name: David Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: