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

Not Applicable

Terminated

Conditions: Osteoarthritis

Interventions: Device: Uniglide Fixed Bearing Unicondylar Knee System
Device: Uniglide Mobile Bearing Unicondylar Knee System

Registration Number: NCT00740376

Lead Sponsor: Corin

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 37

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uniglide Fixed Bearing	Uniglide Fixed Bearing Unicondylar Knee System	Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Uniglide Mobile Bearing	Uniglide Mobile Bearing Unicondylar Knee System	Uniglide Mobile Bearing Unicondylar Knee System (MBK)

Primary Outcome Measures

Name	Time	Method
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.	Month 24 postoperative	CCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines \>1mm in \>50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) \> 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations \> 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery.

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)	Month 24 postoperative	Knee injury and Osteoarthritis Outcome Score (pain): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (symptoms): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (activities of daily living (ADL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport/rec): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life (QOL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport and recreation): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life): 0 (worst) - 100 (best)
Number of Implants With Any Device-related Complications	Month 24 postoperative
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively	Month 24 postoperative	For both the Tibial \& Femoral Components the following were recorded: Implant Subsidence \> 2mm (recorded for the tibial component only) Implant Loosening \> 2deg Radiolucent Line (RLL) in \>50% zones Progressive RLL Osteolysis ≥ 5mm
American Knee Society Score (AKSS) (Total, Pain & Function Scores)	Month 24 postoperative	American Knee Society Score (AKSS) Total Score - Range: 0 (worst) - 100 (best) Pain Score - Range: 0 (worst) - 50 (best) Function Score - Range: 0 (worst) - 100 (best)
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)	Month 24 postoperative	HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best)
Survival Rate Using Kaplan-Meier Survival Curves	Month 24 postoperative	Kaplan-Meier survival curves will be plotted for All Enrolled investigational devices and All Enrolled control devices on the same graph to facilitate graphical comparisons of survivorship over time.

Trial Locations

Locations (6): S.T.A.R. Orthopaedics, Inc.
🇺🇸
La Quinta, California, United States
Bluegrass Orthopaedics and Hand Care
🇺🇸
Lexington, Kentucky, United States
Texas Orthopedic Specialists
🇺🇸
Bedford, Texas, United States
Texas Center for Joint Replacement
🇺🇸
Plano, Texas, United States
Orthopaedic Associates of West Florida
🇺🇸
Clearwater, Florida, United States
Memorial Bone & Joint
🇺🇸
Houston, Texas, United States