Last updated: March 29, 2021
Sponsor: Zimmer Biomet
Overall Status: Terminated
Phase
N/A
Condition
Musculoskeletal Diseases
Osteoarthritis
Bone Diseases
Treatment
N/AClinical Study ID
NCT01763684
ORTHO.CR.GK7
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Intended for use in individuals with osteoarthritis or Avascular necrosis limited tothe medial compartment of the knee that is also lacking patellofemoral or lateralcompartment disease.
- Use of cementless femoral fixation is permitted outside of the United States if itcomplies with all local, state, and/or national and international regulations. Thesame technique must be used consistently throughout the course of the study with allcases
- Patients 21 and over
Exclusion
Exclusion Criteria:
- Use of Cementless Fixation in the United States
- Infection, sepsis or osteomyelitis
- Use in lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of failed prosthesis, failed upper tibial osteotomy, or post traumaticarthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which wouldpreclude stability of the device.
- Disease or damage to the lateral compartment of the knee
- Uncooperative patient or patient with neurologic disorders who is incapable offollowing directions
- Osteoporosis in the United States / Insufficient bone stock outside the United States
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent onroentgenogram
- Vascular insufficiency, muscular atrophy, neuromuscular disease.
- Incomplete or deficient soft tissue surrounding the knee.
- Charcot's disease
- A fixed varus deformity (not passively correctable) of greater than 15 degrees
- A flexion deformity greater than 15 degrees.
- Non-staged Bilateral patients
- Patients who refuse, cannot, or should not receive a CT or MRI. Since patients arerandomized into treatment groups, all patients must be able to receive an MRI (shouldfollow local MRI screening protocol). This excludes patients who have metal artifactsin the knee, patients who are too large to fit into the knee coil, patients withpacemakers, patients unable to lie still for the duration of the MRI, and patients whoare claustrophobic.
Study Design
Total Participants: 266
Study Start date:
September 01, 2012
Estimated Completion Date:
August 31, 2016
Study Description
Connect with a study center
Orthopedic and Sports Medicine Center
Elkhart, Indiana 46514
United StatesSite Not Available
The Orthopaedic Center
Rockville, Maryland 20850
United StatesSite Not Available
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri 65212
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27703
United StatesSite Not Available
Joint Implant Surgeons
Columbus, Ohio 43054
United StatesSite Not Available
Texas Institute for Hip & Knee Surgery
Austin, Texas 78751
United StatesSite Not Available
Advanced Orthopedics
Richmond, Virginia 23294
United StatesSite Not Available

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