Mobile - Bearing Knee Study

Completed · Phase 3

Conditions studied: Inflammatory Tissue Disorder, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis, Secondary Arthritis

In brief

To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.

Key facts

Study ID

NCT00765362

Run by

Encore Medical, L.P.

People needed

419

Starts

2000-01-01

Expected to finish

2008-08-01

Last updated by the study team

2011-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Carl T. Hayden VA Hospital — Phoenix, Arizona, United States
• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• S.Florida VA Found. For Research & Education, Inc. — Miami, Florida, United States
• Great Lakes Orthopaedics — Garden City, Michigan, United States
• Study site — Hilton Head Island, South Carolina, United States
• Orthopedic Surgery Center and Sports Medicine — Edinburg, Texas, United States
• The Orthopedic Specialty Hospital — Murray, Utah, United States
• Study site — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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