The treatment of medial compartmental knee osteoarthritis (OA) symptoms with the KineSpring™ Unicompartmental Knee Arthroplasty (UKA) System
| ISRCTN | ISRCTN63048529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63048529 |
| Secondary identifying numbers | KINE-0902 |
- Submission date
- 26/06/2009
- Registration date
- 14/07/2009
- Last edited
- 12/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Not provided at time of registration
Contact information
Scientific
Institute of Orthopaedics
Robert Jones and Agnes Hunt Orthopaedic and District Hospital
Oswestry Outcome Centre
Oswestry, Shropshire
SY10 7AG
United Kingdom
Scientific
Department of Orthopaedic Surgery and Traumatology
University Hospital
University of Gent
De Pintelaan 185, 1P5
Gent
9000
Belgium
Scientific
University Hospital of Wales
Cardiff and Vale NHS Trust
Heath Park
Cardiff
CF14 4XW
United Kingdom
Scientific
Derbyshire Royal Infirmary
Derby Hospitals Foundation
London Road
Derby
DEL 2QY
United Kingdom
Scientific
Harrogate District Hospital
Harrogate & District NHS Foundation Trust
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom
Scientific
The Duchy BMI
Queens Road
Harrogate
HG2 0HF
United Kingdom
Study information
| Study design | Prospective multicentre open-label non-randomised non-inferiority study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre open-label interventional study of patients with medial compartmental knee osteoarthritis (OA) symptoms treated with the KineSpring™ Unicompartmental Knee Arthroplasty (UKA) System |
| Study acronym | COAST |
| Study hypothesis | The null hypothesis (H0) is that the Knee Society Score (KSS) for function derived from subjects treated with the KineSpring™ UKA System is inferior to a mean KSS for function of 80 which is widely reported in applicable literature: H0: KSS less than or equal to 80 - d The alternative hypothesis (H1) is that the KSS for function associated with KineSpring™ UKA System subjects is not inferior: H1: KSS greater than 80 - d |
| Ethics approval(s) | 1. University of Ghent, Belgium, 07/10/2009 2. Leeds West Research Ethics Committee, UK, 21/10/2009 3. All other centers have received ethics approval before recruitment of the first participant |
| Condition | Osteoarthritis of the knee |
| Intervention | Arthroplasty of the knee. There is only one treatment arm as the results of this arm will be compared to a historical control. The surgical procedure lasts 1.5 to 2 hours. Enrolment will take place over 9 months with 24 year follow-up there after, so any one patient will participate in the study for a maximum of 24 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The KSS Function score 6 months post-KineSpring™ UKA System surgery |
| Secondary outcome measures | 1. Procedural success (i.e., successful implantation of the device) 2. Treatment-emergent AEs at surgery, 2 and 6 weeks, 3, 6, 12, 18, and 24 months (to include device malfunctions/unanticipated adverse device evaluations (UADEs) 3. Subject reported symptom severity changes from baseline measurement at 6 weeks, 3, 6, 12, 18, and 24 months in the following criteria: 3.1. KOOS score 3.2. EuroQol (EQ-5D) 3.3. Lysholm Knee Scale 3.4. Knee Specific Pain Scale 3.5. Investigator's assessment of patients' global status 3.6. Activity Profile 3.7. Patient Overall Treatment Evaluation 4. KSS knee and function scores at 6 weeks, 3, 6, 12, 18, and 24 months 5. KineSpring™ UKA System stability through evaluation of radiographic parameters at 3, 6, 12, and 24 month follow-up |
| Overall study start date | 30/09/2009 |
| Overall study end date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Aged greater than or equal to 25 years, either sex 2. Diagnosis of medial OA of the target knee based on American College of Rheumatology (ACR) Clinical and Radiographic or Clinical Classification criteria for osteoarthritis with a minimum 12 month history 3. Continued knee pain despite minimum 3 months of conservative therapy, (i.e., physical therapy, bracing, orthotics, systemic or injected medications) 4. Knee flexion greater than or equal to 90 degrees 5. KSS knee and function scores less than 70 6. Weight greater than 60 kg 7. Ability to tolerate antibiotics 8. Willing and able to give voluntary written informed consent to participate in this clinical investigation 9. Prepared to consent to the transfer of his/her information to third parties 10. Willing to undertake the required investigational procedures and willing to return for the required follow-up evaluations |
| Participant exclusion criteria | 1. Active infection, sepsis or osteomyelitis, history of infection in the target knee or distant foci of infections which may spread to the implant site 2. Rheumatoid arthritis or other forms of inflammatory joint disease 3. Significant OA in lateral or patellofemoral compartment 4. Previous surgery in the target knee within 12 months prior to screening 5. Previous osteotomy or failed knee endoprostheses of any kind in the target knee 6. Tibial-femoral varus or valgus alignment greater than 10 degrees 7. Ligamentous or meniscal instability as assessed by the Investigator 8. Concomitant immunosuppressive therapy 9. Paget's disease or metabolic disorders which may impair bone formation 10. Osteomalacia or moderate to severe osteoporosis, rapid joint destruction, marked bone loss or bone resorption noted on x-ray 11. Charcot's joint disease or other severe neurosensory deficits 12. Incomplete or deficient soft tissue surrounding the knee as assessed by the Investigator 13. Flexion deformity greater than 10 degrees 14. Uncontrolled diabetes mellitus or other significant co-morbidities 15. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc) or other factor (e.g. planned relocation, uncooperative patient) that the Investigator feels would interfere with study participation 16. The patient is pregnant or lactating 17. Historic or ongoing litigation for or participation in workers compensation for musculoskeletal injuries or disorders 18. Subjects who are currently enrolled in another clinical investigation |
| Recruitment start date | 30/09/2009 |
| Recruitment end date | 01/01/2014 |
Locations
Countries of recruitment
- Belgium
- England
- United Kingdom
Study participating centre
SY10 7AG
United Kingdom
Sponsor information
Industry
26460 Corporate Ave.
Suite 100
Hayward, California
94545
United States of America
| Website | http://www.moximed.com/ |
|---|---|
"ROR" |
https://ror.org/04hrwvd56 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/09/2013: The target number of participants was changed from 30 to 40 and the overall trial end date was changed from 30/06/2012 to 01/01/2014.
