OsteoarthritisMBKNCT00740376
Uniglide™ Mobile Bearing Unicondylar Knee System vs the Uniglide™ Fixed Bearing Unicondylar Knee System
A study testing Uniglide Mobile Bearing Unicondylar Knee System and Uniglide Fixed Bearing Unicondylar Knee System in people with Osteoarthritis, run by Corin at 6 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Uniglide Mobile Bearing Unicondylar Knee System and Uniglide Fixed Bearing Unicondylar Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2008to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Orthopedic Specialists
Bedford, Texas, 76021
Orthopaedic Associates of West Florida
Clearwater, Florida, 33756
Memorial Bone & Joint
Houston, Texas, 77043
S.T.A.R. Orthopaedics, Inc.
La Quinta, California, 92253
Bluegrass Orthopaedics and Hand Care
Lexington, Kentucky, 40509
Texas Center for Joint Replacement
Plano, Texas, 75093
About this study
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
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.
- Conditions
- Osteoarthritis
- Being tested
- Uniglide Mobile Bearing Unicondylar Knee System, Uniglide Fixed Bearing Unicondylar Knee System
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uniglide Mobile Bearing Unicondylar Knee SystemDevice
Also called unicondylar knee, unicompartmental knee, partial knee
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).
Uniglide Fixed Bearing Unicondylar Knee SystemDevice
Also called unicondylar knee, unicompartmental knee, partial knee
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 group | Role | What they receive |
|---|---|---|
| Uniglide Mobile Bearing | Experimental | Uniglide Mobile Bearing Unicondylar Knee System (MBK) Receives: Device: Uniglide Mobile Bearing Unicondylar Knee System |
| Uniglide Fixed Bearing | Active comparator | Uniglide Fixed Bearing Unicondylar Knee System (FBK) Receives: Device: Uniglide Fixed Bearing Unicondylar Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 24 postoperative
Secondary outcomes (6)
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)
Measured: Month 24 postoperative
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)
Measured: Month 24 postoperative
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)
Measured: Month 24 postoperative
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.
Measured: Month 24 postoperative
Number of Implants With Any Device-related Complications
Measured: Month 24 postoperative
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
Measured: Month 24 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janice Fleming, Study director, Corin Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740376
- Sponsor's protocol ID
- Uniglide MBK
- Acronym
- MBK
- Status last verified
- May 2019
- First submitted
- 21 Aug 2008
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00740376
- Acronym / sponsor ID
- MBK / Uniglide MBK
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uniglide Mobile Bearing | Experimental | Device: Uniglide Mobile Bearing Unicondylar Knee SystemUniglide Mobile Bearing Unicondylar Knee System (MBK) |
| Uniglide Fixed Bearing | Active comparator | Device: Uniglide Fixed Bearing Unicondylar Knee SystemUniglide Fixed Bearing Unicondylar Knee System (FBK) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uniglide Mobile Bearing Unicondylar Knee SystemAlso: unicondylar knee, unicompartmental knee, partial kneeUniglide 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). | Device | Uniglide Mobile Bearing |
| Uniglide Fixed Bearing Unicondylar Knee SystemAlso: unicondylar knee, unicompartmental knee, partial kneeUniglide 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). | Device | Uniglide Fixed Bearing |
Primary outcome
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24.
Time frame: 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.
6 secondary outcomes
American Knee Society Score (AKSS) (Total, Pain & Function Scores)
Time frame: Month 24 postoperative
Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores)
Time frame: Month 24 postoperative
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores)
Time frame: Month 24 postoperative
Survival Rate Using Kaplan-Meier Survival Curves
Time frame: Month 24 postoperative
Number of Implants With Any Device-related Complications
Time frame: Month 24 postoperative
The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively
Time frame: Month 24 postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Fleming study director
Corin Ltd
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniglide Mobile Bearing Unicondylar Knee System and Uniglide Fixed Bearing Unicondylar Knee System in people with Osteoarthritis, run by Corin at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24. (time frame: Month 24 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.