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

NCT00740376 | Terminated Results DMC

• 1 other identifier: Uniglide MBK
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 6

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.

Conditions

Osteoarthritis

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.

  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.

  Month 24 postoperative

Secondary Outcomes (6)

• American Knee Society Score (AKSS) (Total, Pain & Function Scores)

  Month 24 postoperative

• Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)

  Month 24 postoperative

• Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)

  Month 24 postoperative

• Survival Rate Using Kaplan-Meier Survival Curves

  Month 24 postoperative

• Number of Implants With Any Device-related Complications

  Month 24 postoperative

Study Arms (2)

Uniglide Mobile Bearing

EXPERIMENTAL

Uniglide Mobile Bearing Unicondylar Knee System (MBK)

Device: Uniglide Mobile Bearing Unicondylar Knee System

Uniglide Fixed Bearing

ACTIVE COMPARATOR

Uniglide Fixed Bearing Unicondylar Knee System (FBK)

Device: Uniglide Fixed Bearing Unicondylar Knee System

Interventions

Uniglide Mobile Bearing Unicondylar Knee System 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).

Also known as: unicondylar knee, unicompartmental knee, partial knee

Uniglide Mobile Bearing

Uniglide Fixed Bearing Unicondylar Knee System 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).

Also known as: unicondylar knee, unicompartmental knee, partial knee

Uniglide Fixed Bearing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corin: lead

Study Sites (6)

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

La Quinta, California, 92253, United States

Location

Orthopaedic Associates of West Florida

Clearwater, Florida, 33756, United States

Location

Bluegrass Orthopaedics and Hand Care

Lexington, Kentucky, 40509, United States

Location

Texas Orthopedic Specialists

Bedford, Texas, 76021, United States

Location

Memorial Bone & Joint

Houston, Texas, 77043, United States

Location

Texas Center for Joint Replacement

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Global Regulatory Affairs and Clinical Director
• Organization: Corin

+44 (0)1285 659866

Study Officials

• Janice Fleming

  Corin Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 25, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-05

Locations

US (6)