Mobile - Bearing Knee Study | NCT00765362 | Trialant
CompletedInterventionalPhase 3Updated May 11, 2011
Mobile - Bearing Knee Study
Encore Mobile - Bearing Knee Study #200
ClinicalTrials.gov ID
NCT00765362
Lead Sponsor
Encore Medical, L.P.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
419Actual
Last Update Posted
May 11, 2011Estimated
Start Date
Jan 2000
Primary Completion Date
Jun 2008Actual
Completion Date
Aug 2008Actual
Official Title
Encore Mobile - Bearing Knee Study #200
Brief Summary
To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
Inflammatory Tissue Disorder
Osteoarthritis
Avascular Necrosis
Post-traumatic Arthritis
Secondary Arthritis
Encore Mobile-Bearing Knee
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Skeletal maturity
Less than 70 on preoperative Knee Society Score (Rating Score)
Sufficient bone stock, as judged by radiographs, to support primary knee implant
Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
Patient is not pregnant
Primary total knee replacement
Sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
Varus deformity <45 or valgus deformity <45 or fixed flexion deformity <90
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures
Exclusion Criteria:
Skeletal immaturity
Greater than or equal to 70 on preoperative Knee Society Score (Rating Scale)
Previous knee surgery that has adversely affected bone stock or prior total knee replacement
Post patellectomy
Patient is pregnant
Insufficient collateral ligaments, as judged by the physician
Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity).
Varus deformity >45 or valgus deformity >45 or fixed flexion deformity >90.
Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and Alzheimer's Disease).
Prisoners
Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
Primary Purpose
Treatment
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Carl T. Hayden VA Hospital
Phoenix, Arizona 85012, United States
Orange Coast Memorial Medical Center
Fountain Valley, California 92708, United States
S.Florida VA Found. For Research & Education, Inc.
Miami, Florida 33125, United States
Great Lakes Orthopaedics
Garden City, Michigan 48135, United States
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Hilton Head Island, South Carolina 29926, United States