Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System

NCT ID: NCT00740376

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed Bearing Unicondylar Knee System (control device currently cleared) as measured by the Composite Clinical Success (CCS) endpoint.

Detailed Description

Arthritic knees are the most common cause of long-term disability resulting in decreased mobility and increased pain. After other treatments for pain relief and return to activities of daily living fail, knee joint replacement is often the best option and unicompartmental knee arthroplasty was introduced as an appropriate treatment for management of osteoarthritis when disease effects only a portion of the knee joint. This study is a prospective, comparative, randomized, double blind (patient and post-operative evaluator), multi-center clinical study under a common protocol to determine the safety and effectiveness of the Uniglide Unicondylar Mobile Bearing knee implant system.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Uniglide Mobile Bearing

Uniglide Mobile Bearing Unicondylar Knee System (MBK)

Group Type: EXPERIMENTAL

Uniglide Mobile Bearing Unicondylar Knee System

Intervention Type: DEVICE

Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo)that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo)tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).

Uniglide Fixed Bearing

Uniglide Fixed Bearing Unicondylar Knee System (FBK)

Group Type: ACTIVE_COMPARATOR

Uniglide Fixed Bearing Unicondylar Knee System

Intervention Type: DEVICE

Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).

Interventions

Uniglide Mobile Bearing Unicondylar Knee System

Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo)that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo)tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert).

Intervention Type: DEVICE

Uniglide Fixed Bearing Unicondylar Knee System

Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764).

Intervention Type: DEVICE

Other Intervention Names

unicondylar knee; unicompartmental knee; partial knee; unicondylar knee; unicompartmental knee; partial knee

Eligibility Criteria

Inclusion Criteria

• skeletally mature
• need to obtain pain relief and improved function
• moderate or severe pain with either walking or at rest on the Hospital for Special Surgery Score
• preoperative medial tibiofemoral joint space narrowing on x-rays (Kellgren Lawrence grade 3 or 4)
• preoperative Hospital for Special Surgery Knee Evaluation total score of < 69
• preoperative arc of motion of > 90o in the affected knee
• diagnosed with osteoarthritis in the medial compartment of the knee and non-surgical treatment options have failed to provide relief for symptoms
• able to understand this clinical trial, co-operate with study procedures, and are willing to return to the clinic, and/or hospital for all the required post-operative follow-ups
• able to give and have given voluntary, written informed patient consent to participate in this clinical investigation and have provided Authorization for Release of Personal Health Information (HIPAA) for the purpose of this clinical study
• willing to be randomized with either of the devices used in the clinical trial as determined by the randomization schedule

Exclusion Criteria

• neurological disorders which may interfere or adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis)
• a nutritional problem (protein, calorie, or vitamin/mineral deficiency) that may impair wound healing mechanisms
• a diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
• immunologically suppressed
• on chronic corticosteroid or non-steroidal anti-inflammatory therapy
• with Charcot's disease
• with metabolic disorders (e.g. osteomalacia), which may impair bone formation
• with distant foci of infections, which may spread to the implant site
• have presence of vascular insufficiency, muscular atrophy and neuromuscular disease
• have diagnosed osteoporosis as evidenced on a DEXA scan (within the last 12 months)
• ave diagnosed rheumatoid arthritis or other forms of inflammatory joint disease
• have diagnosed avascular necrosis
• with malunion, arthrodesis or severe dysplasia in the affected limb
• with rapid joint destruction, marked bone loss or bone resorption in the affected knee apparent on x-ray
• have incomplete or deficient soft tissue surrounding the affected knee
• have infection, sepsis or osteomyelitis in the affected knee
• have had revision of previously failed prosthesis, failed upper tibial osteotomy or post traumatic arthritis after tibial plateau fracture in the affected knee
• 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
• with insufficient collateral, anterior or posterior cruciate ligaments in the affected knee, which would preclude stability of the device
• with disease or damage to the lateral compartment of the affected knee (Outerbridge classification II, III, or IV)
• with a Body Mass Index > 36
• 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. (as assessed using the Outerbridge Classification system).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janice Fleming

Role: STUDY_DIRECTOR

Corin Ltd

Locations

S.T.A.R. Orthopaedics, Inc.

La Quinta, California, United States

Orthopaedic Associates of West Florida

Clearwater, Florida, United States

Bluegrass Orthopaedics and Hand Care

Lexington, Kentucky, United States

Texas Orthopedic Specialists

Bedford, Texas, United States

Memorial Bone & Joint

Houston, Texas, United States

Texas Center for Joint Replacement

Plano, Texas, United States

Countries

United States

Other Identifiers

Uniglide MBK

Identifier Type: -

Identifier Source: org_study_id