In This SectionTexas Health Research & Education Institute
Disease or Condition
Osteoarthritis / Knee Replacement
Comparison of Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System in Patients with Osteoarthritis (Osteoarthritis / Knee replacement)
This study is for patients with osteoarthritis in the medial compartment (inside part) of your knee. This study is designed to compare the safety and effectiveness of the Uniglide Mobile Bearing Unicondylar Knee System (investigational device in the study) to the Uniglide Fixed Bearing Unicondylar Knee System (standard control device cleared by the FDA). We will perform x rays and collect information on the status of your knee joint and your ability to carry out daily activities before your surgery, after your surgery and at 2 weeks, 6 weeks, 6 months, 1 and 2 years after surgery and every 2 years annually until the last patient enrolled reaches the 2 year mark.
Patients between 40 and 75 years of age.
Patients who are skeletally mature.
Patients who need to obtain pain relief and improved function.
Patients with either moderate or severe pain with either walking or at rest on the Hospital for Specila Surgery Score.
Patients who have preoperative medial tibiofemoral joint space narrowing on x rays.
Patients with a preoperative arc of motion of > or equal to 90 degrees in the affected knee.
Patients who are diagnosed with osteoarthritis in the medial compartment of the knee and non-surgical treatment options have failed to provide relief for symptoms.
Patients with neurological disorders which may interfere or adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis).
Patients with a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms.
Patients with a diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy).
Patients with immunologically suppressed on chronic corticosteroid or non-steroidal anti-inflammatory therapy.
Patients with with Charcot's disease.
Patients with metabolic disorders (e.g. osteomalacia), which may impair bone formation.
Patients with distant foci of infections, which may spread to the implant site.
Patients who have presence of vascular insufficiency, muscular atrophy and neuromuscular disease.
Patients who have diagnosed osteoporosis as evidenced on a DEXA scan (within the last 12 months).
Patients who have diagnosed rheumatoid arthritis or other forms of inflammatory joint disease.
Patients who have diagnosed avascular necrosis
Patients with malunion, arthrodesis or severe dysplasia in the affected limb.
Patients with rapid joint destruction, marked bone loss or bone resorption in the affected knee apparent on x-ray.
Patients who have incomplete or deficient soft tissue surrounding the affected knee.
Patients who have infection, sepsis or osteomyelitis in the affected knee.
Patients who have had revision of previously failed prosthesis, failed upper tibial osteotomy or post traumatic arthritis after tibial plateau fracture in the affected knee.
Patients with a fixed varus deformity (not passively correctable) of greater than 15 degrees and a flexion deformity greater than 15 degrees in the affected knee.
Patients with insufficient collateral, anterior or posterior cruciate ligaments in the affected knee, which would preclude stability of the device.
Patients with disease or damage to the lateral compartment of the affected knee (Outerbridge classification II, III, or IV).
Patients with a Body Mass Index > 30.
Patients with a sensitivity to device material.
Females who are pregnant.
Prisoners, known drug or alcohol abuser, smoker, or have a psychological disorder.
Based upon intra-operative assessment, cartilage and bone erosions involving more than the anterior and middle parts of the medial compartment. The posterior part of the medial compartment and the lateral compartment having cartilage of less than normal thickness.