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TerminatedNCT00740376MBKUpdated Jun 13, 2019Results posted

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

An interventional study of Uniglide Mobile Bearing Unicondylar Knee System and Uniglide Fixed Bearing Unicondylar Knee System in Osteoarthritis, sponsored by Corin. Terminated at 6 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Corin · Not applicable, Interventional, and Treatment

Why this study was terminated
Poor enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 37 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Corin is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Uniglide Mobile Bearing

    Uniglide Mobile Bearing Unicondylar Knee System (MBK)

    Device: Uniglide Mobile Bearing Unicondylar Knee System

  • Active comparator
    Uniglide Fixed Bearing

    Uniglide Fixed Bearing Unicondylar Knee System (FBK)

    Device: Uniglide Fixed Bearing Unicondylar Knee 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).

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

  • 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).

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

06

What researchers measure

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.

    Time frame: Month 24 postoperative

Secondary outcomes

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

    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)

    Time frame: Month 24 postoperative

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

    HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best)

    Time frame: Month 24 postoperative

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

    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)

    Time frame: Month 24 postoperative

  4. Survival Rate Using Kaplan-Meier Survival Curves

    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.

    Time frame: Month 24 postoperative

  5. Number of Implants With Any Device-related Complications

    Time frame: Month 24 postoperative

  6. The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively

    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

    Time frame: Month 24 postoperative

07

Results

Posted Jun 13, 2019

Participant flow

Participant flow — Overall Study
MilestoneUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Started2215
Completed1912
Not completed33

Outcome measures

PrimaryThe 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.

Time frame:
Month 24 postoperative
Reported as:
Count of units · Implants
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.
ImplantsUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.1715
SecondaryAmerican Knee Society Score (AKSS) (Total, Pain & Function Scores)

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)

Time frame:
Month 24 postoperative
Reported as:
Mean · score on a scale
American Knee Society Score (AKSS) (Total, Pain & Function Scores)
score on a scaleUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Mean Pain Score48.00 ± 6.7742.63 ± 10.32
Mean Function Score95.50 ± 10.5094.74 ± 11.72
Mean Total Score94.53 ± 8.4689.58 ± 12.87
SecondaryHospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)

HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best)

Time frame:
Month 24 postoperative
Reported as:
Mean · score on a scale
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)
score on a scaleUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Mean Total Score95.25 ± 5.3193.63 ± 6.18
Mean Pain Score29.25 ± 2.4528.16 ± 3.80
Mean Function Score21.30 ± 1.7820.79 ± 1.51
SecondaryKnee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)

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)

Time frame:
Month 24 postoperative
Reported as:
Mean · score on a scale
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
score on a scaleUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Mean Pain Score91.35 ± 11.1592.00 ± 9.71
Mean Symptoms Score63.82 ± 13.8766.73 ± 15.54
Mean ADL Score93.65 ± 10.2192.67 ± 9.80
Mean Sport/Rec Score77.94 ± 21.2278.67 ± 21.17
Mean QOL Score83.94 ± 15.1184.27 ± 13.26
SecondarySurvival Rate Using Kaplan-Meier Survival Curves

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.

Time frame:
Month 24 postoperative
Reported as:
Count of units · Implants
Survival Rate Using Kaplan-Meier Survival Curves
ImplantsUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Survival Rate Using Kaplan-Meier Survival Curves2421
SecondaryNumber of Implants With Any Device-related Complications
Time frame:
Month 24 postoperative
Reported as:
Count of units · Implants
Number of Implants With Any Device-related Complications
ImplantsUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Number of Implants With Any Device-related Complications30
SecondaryThe Number of Implants With Any Radiographic Findings at Month 24 Post Operatively

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

Time frame:
Month 24 postoperative
Reported as:
Count of units · Implants
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
ImplantsUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Tibial Implant Subsidence00
Tibial Implant Loosening00
Tibial RLL11
Tibial Progressive RLL31
Tibial Osteolysis10
Femoral Implant Loosening00
Femoral RLL01
Femoral Progressive RL01
Femoral Osteolysis00

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Uniglide Mobile Bearing Unicondylar Knee System (MBK)0/22 (0%)6/22 (27.3%)20/22 (90.9%)
Uniglide Fixed Bearing Unicondylar Knee System (FBK)0/15 (0%)7/15 (46.7%)14/15 (93.3%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
Myocardial infarctionCardiac disorders0/222/15
Contralateral TKRSurgical and medical procedures2/220/15
Carpal tunnel release surgerySurgical and medical procedures0/221/15
Contralateral knee hematoma drainageSurgical and medical procedures0/221/15
Contralateral knee traumatic wound dehiscenceSurgical and medical procedures0/221/15
Gastrointestinal polyp removalSurgical and medical procedures0/221/15
Knee hematoma drainage (operative side)Surgical and medical procedures0/221/15
LumbagoMusculoskeletal and connective tissue disorders0/221/15
Traumatic knee-wound dehiscence (operative side)Injury, poisoning and procedural complications0/221/15
Chronic lymphocytic leukaemia anemiaBlood and lymphatic system disorders1/220/15
Most frequent other events
Showing 10 of 70
Most frequent other events
EventUniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)
NauseaGastrointestinal disorders7/227/15
ConstipationGastrointestinal disorders3/224/15
InsomniaGeneral disorders0/224/15
Muscle spasmMusculoskeletal and connective tissue disorders4/222/15
Nausea and vomitingGastrointestinal disorders4/221/15
Acute post-op blood loss anemiaInjury, poisoning and procedural complications3/221/15
Post-fall knee pain (operative side)Injury, poisoning and procedural complications3/221/15
SleeplessnessGeneral disorders3/220/15
ItchingSkin and subcutaneous tissue disorders2/222/15
Knee pain (operative side)Musculoskeletal and connective tissue disorders2/222/15

Baseline characteristics

Age, Continuous
Age, Continuous(years)Uniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)Total
Mean60.42 (48 to 71)57.48 (43 to 77)58.95 (43 to 77)
Sex: Female, Male
Sex: Female, Male(Implants)Uniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)Total
Female18725
Male81422
Region of Enrollment
Region of Enrollment(Implants)Uniglide Mobile Bearing Unicondylar Knee System (MBK)Uniglide Fixed Bearing Unicondylar Knee System (FBK)Total
United States262147
08

Study locations

6 sites
  • S.T.A.R. Orthopaedics, Inc.
    La Quinta, California 92253, United States
  • Orthopaedic Associates of West Florida
    Clearwater, Florida 33756, United States
  • Bluegrass Orthopaedics and Hand Care
    Lexington, Kentucky 40509, United States
  • Texas Orthopedic Specialists
    Bedford, Texas 76021, United States
  • Memorial Bone & Joint
    Houston, Texas 77043, United States
  • Texas Center for Joint Replacement
    Plano, Texas 75093, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00740376
Lead sponsor
Corin
Responsible party
Sponsor
First posted
Aug 25, 2008
Start date
Aug 2008
Primary completion
May 2014
Completion
May 2014
Results posted
Jun 13, 2019
Last update
Jun 13, 2019

Study contacts

Janice Fleming
study director · Corin Ltd

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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