Status:
COMPLETED
Mobile - Bearing Knee Study
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Inflammatory Tissue Disorder
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00765362
Start Date
January 1 2000
End Date
August 1 2008
Last Update
May 11 2011
Active Locations (8)
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1
Carl T. Hayden VA Hospital
Phoenix, Arizona, United States, 85012
2
Orange Coast Memorial Medical Center
Fountain Valley, California, United States, 92708
3
S.Florida VA Found. For Research & Education, Inc.
Miami, Florida, United States, 33125
4
Great Lakes Orthopaedics
Garden City, Michigan, United States, 48135