Condition category
Musculoskeletal Diseases
Date applied
26/06/2009
Date assigned
14/07/2009
Last edited
12/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof James B. Richardson

ORCID ID

Contact details

Institute of Orthopaedics
Robert Jones and Agnes Hunt Orthopaedic and District Hospital
Oswestry Outcome Centre
Oswestry
Shropshire
SY10 7AG
United Kingdom

Type

Scientific

Additional contact

Prof Jan Victor

ORCID ID

Contact details

Department of Orthopaedic Surgery and Traumatology
University Hospital
University of Gent
De Pintelaan 185
1P5
Gent
9000
Belgium

Type

Scientific

Additional contact

Mr Rhys Williams

ORCID ID

Contact details

University Hospital of Wales
Cardiff and Vale NHS Trust
Heath Park
Cardiff
CF14 4XW
United Kingdom

Type

Scientific

Additional contact

Mr Timothy Wilton

ORCID ID

Contact details

Derbyshire Royal Infirmary
Derby Hospitals Foundation
London Road
Derby
DEL 2QY
United Kingdom

Type

Scientific

Additional contact

Mr Nicolas John London

ORCID ID

Contact details

Harrogate District Hospital
Harrogate & District NHS Foundation Trust
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom

Type

Scientific

Additional contact

Mr Nicolas John London

ORCID ID

Contact details

The Duchy BMI
Queens Road
Harrogate
HG2 0HF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KINE-0902

Study information

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

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

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

Study design

Prospective multicentre open-label non-randomised non-inferiority study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

30/09/2009

Overall trial end date

01/01/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

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, United Kingdom

Trial participating centre

Robert Jones and Agnes Hunt Orthopaedic and District Hospital
Oswestry
SY10 7AG
United Kingdom

Sponsor information

Organisation

Moximed Inc. (USA)

Sponsor details

26460 Corporate Ave.
Suite 100
Hayward
California
94545
United States of America

Sponsor type

Industry

Website

http://www.moximed.com/

Funders

Funder type

Industry

Funder name

Moximed Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

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.