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

A Prospective, Comparative, Randomized, Double Blind, Multi-center Study of the Uniglide™ Mobile Bearing Unicondylar Knee System vs. Uniglide™ Fixed Bearing Unicondylar Knee System

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00740376

Acronym

MBK

Enrollment

Registered

2008-08-25

Start date

2008-08-31

Completion date

2014-05-31

Last updated

2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis

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.

Interventions

DEVICEUniglide 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).

DEVICEUniglide 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)
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)
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
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Uniglide Mobile Bearing Unicondylar Knee System (MBK) Uniglide Mobile Bearing Unicondylar Knee System (MBK) 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).	22
Uniglide Mobile Bearing Unicondylar Knee System (MBK) Uniglide Mobile Bearing Unicondylar Knee System (MBK) 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).	26
Uniglide Fixed Bearing Unicondylar Knee System (FBK) Uniglide Fixed Bearing Unicondylar Knee System (FBK) 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).	15
Uniglide Fixed Bearing Unicondylar Knee System (FBK) Uniglide Fixed Bearing Unicondylar Knee System (FBK) 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).	21
Total	84

Baseline characteristics

Characteristic	Uniglide Mobile Bearing Unicondylar Knee System (MBK)	Uniglide Fixed Bearing Unicondylar Knee System (FBK)	Total
Age, Continuous	60.42 years	57.48 years	58.95 years
Region of Enrollment United States	26 Implants	21 Implants	47 Implants
Sex: Female, Male Female	18 Implants	7 Implants	25 Implants
Sex: Female, Male Male	8 Implants	14 Implants	22 Implants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 15
other Total, other adverse events	20 / 22	14 / 15
serious Total, serious adverse events	6 / 22	7 / 15

Outcome results

Primary

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.