Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System (MBK)

This study has been terminated.
(enrollment closed)
Sponsor:
Information provided by (Responsible Party):
Corin
ClinicalTrials.gov Identifier:
NCT00740376
First received: August 21, 2008
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: Uniglide Mobile Bearing Unicondylar Knee System
Device: Uniglide Fixed Bearing Unicondylar Knee System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Comparative, Randomized, Double Blind, Multi-center Study of the Uniglide™ Mobile Bearing Unicondylar Knee System vs. Uniglide™ Fixed Bearing Unicondylar Knee System

Resource links provided by NLM:


Further study details as provided by Corin:

Primary Outcome Measures:
  • Composite Clinical Success (CCS): HSS success(Month 24):HSS greater than/equal to 70 (If preop HSS between 60 & 69, HSS greater than 70 plus a min 10 point improvement; No radiographic failure (Month 24): No radiolucent lines greater than 1mm in greater [ Time Frame: Month 24 postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital for Special Surgery knee score (total score, pain, function) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Knee society score (total score, pain, function) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(total score and subscales) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • survival [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
  • major device-related complication [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
  • major procedure-related complication [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
  • radiographic findings including device alignment, quality of implantation, osteolysis and osteoarthritis assessment in the patellofemoral and lateral compartments of the knee [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: August 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Uniglide Mobile Bearing Unicondylar Knee System (MBK)
Device: 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).
Other Names:
  • unicondylar knee
  • unicompartmental knee
  • partial knee
Active Comparator: 2
Uniglide Fixed Bearing Unicondylar Knee System (FBK)
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).
Other Names:
  • unicondylar knee
  • unicompartmental knee
  • partial knee

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740376

Locations
United States, California
S.T.A.R. Orthopaedics, Inc.
La Quinta, California, United States, 92253
United States, Florida
Orthopaedic Associates of West Florida
Clearwater, Florida, United States, 33756
United States, Kentucky
Bluegrass Orthopaedics and Hand Care
Lexington, Kentucky, United States, 40509
United States, Texas
Texas Orthopedic Specialists
Bedford, Texas, United States, 76021
Memorial Bone & Joint
Houston, Texas, United States, 77043
Texas Center for Joint Replacement
Plano, Texas, United States, 75093
Sponsors and Collaborators
Corin
Investigators
Study Director: Kathy Trier, PhD Corin
  More Information

No publications provided

Responsible Party: Corin
ClinicalTrials.gov Identifier: NCT00740376     History of Changes
Other Study ID Numbers: Uniglide MBK, IDE # G070230
Study First Received: August 21, 2008
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Corin:
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014