Clinical trial NCT02501733: Medacta GMK Sphere® Multicenter Post-Market Outcomes Study
Official title: Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Knee Replacement
Total Knee Arthroplasty
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 260
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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 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.

Primary outcomes:
measure: Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively.
timeFrame: Baseline, 2 and 5 year time points
Secondary outcomes:
measure: Total Knee Society Score (KSS)
timeFrame: Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.
measure: Krackow Activity Scale (KAS)
timeFrame: Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
measure: Radiographic Analysis
timeFrame: Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
measure: AP long standing X-ray
timeFrame: Pre-operative and 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Norhtwestern University
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Oklahoma City
country: United States
facility: McBride Orthopedic Hospital
state: Oklahoma
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References: