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
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jocelyn.buly@eoc.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14799
Study information
Scientific title
A magnetic resonance and histological investigation of articular cartilage damage in early stage degenerative disease of the hip joint and evaluation of synthetic labro-chondral graft implantation (INTCLAPH)
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
Not available in web format, please use contact details to request a participant 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 measure
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 (if study stopped)
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
Epsom and St Helier University Hospitals NHS Trust
Carshalton
SM5 1AA
United Kingdom
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
Basic results (scientific)
Publication list