Condition category
Musculoskeletal Diseases
Date applied
22/08/2013
Date assigned
22/08/2013
Last edited
22/08/2013
Prospective/Retrospective
Retrospectively 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

Miss Jocelyn Buly

ORCID ID

Contact details

Cardiology
Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
jocelyn.buly@eoc.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14799

Study information

Scientific title

Acronym

INTCLAPH

Study hypothesis

Healthy joints depend upon specialised cartilage (hyaline cartilage) that covers the surfaces of the articulating bones.

In the hip joint, the ball at the top of the thigh bone (femoral head) moves against a recess in the pelvis (the acetabulum). The acetabulum is deepened by the presence of a fibrous rim (the labrum) that helps to stabilise the joint and keep lubricating fluid between the rubbing surfaces.

When joints are damaged, the hyaline cartilage is lost and the joint becomes painful. In the hip, damage can be caused by repetitive injury to the labrum because the shapes of the ball and socket do not quite match. In time, the labrum begins to separate from the bony acetabular rim and the adjacent hyaline cartilage becomes unstable. As the damage progresses, the cartilage begins to peel away from the underlying bone, the femoral head then rubs against the damaged area and arthritis ensues.

Over the last few years, techniques have been developed, using keyhole surgery, that allow us to repair damage to the labrum and reshape the femoral head to avoid further injury. A number of strategies have also been developed to promote cartilage regeneration in areas of hyaline cartilage loss. These range from simply removing the damaged cartilage, making holes in the underlying bone (microfracturing) to the application of synthetic collagen graft patches. To date no one has compared these different strategies to find out which is the most effective. We propose to undertake a two-centre, prospective, randomised study, on patients with acetabular cartilage loss (adjacent to labral damage) and compare the four most commonly used repair strategies in order to find out which works best. Clinical outcome, X-rays, Computerised tomography (CT), Magnetic Resonance (MR) and biomarkers (blood and urine tests) will be used to evaluate the study subjects.

Ethics approval

13/LO/0753

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Non-inflammatory Joint Disorders

Intervention

tbc, tbc

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

tbc; Timepoint(s): tbc

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/08/2013

Overall trial end date

15/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. History of hip pain.
2. Tönnis grade 0 or 1 radiographic changes.
3. Hip Joint Space Width (JSW) > 2 mm.
4. Arthroscopic confirmation of:
4.1. Labro-chondral split
4.2. Chondral defect grade 3 and 4 (Outerbridge, ICRS & UCL Classifications)
4.3. Chondral defect size range 0.5 – 4.0 cm2.
5. Ability to provide informed written consent.
Target Gender: Male & Female; Upper Age Limit 55 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 45; UK Sample Size: 45

Participant exclusion criteria

1. OA Grade > 1 (Tönnis scale)
2. Inflammatory joint disease
3. Previous dislocation or fracture of the affected hip
4. Previous non-arthroscopic surgery to the affected hip
5. History of back pain
6. Age <18 years and > 55 years
7. BMI > 30
8. Hip joint space = 2 mm
9. Previous hip joint sepsis or osteomyelitis
10. Metabolic bone disease
11. Osteoporosis
12. Avascular necrosis
13. Associated neurological disease
14. Diabetes
15. Pregnancy
16. Chronic use of narcotics or oral steroids
17. Heavy alcohol intake on a regular basis
18. Inability to give consent or cooperate with the study protocol
19. Non-English speaking patients
20. Patients who move outside United Kingdom

Recruitment start date

15/08/2013

Recruitment end date

15/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiology, Epsom and St Helier University Hospitals NHS Trust
Carshalton
SM5 1AA
United Kingdom

Sponsor information

Organisation

St George's University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Orthopaedic Research UK; Grant Codes: 491

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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