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

ISRCTN	ISRCTN01688855
DOI	https://doi.org/10.1186/ISRCTN01688855
Secondary identifying numbers	14799

Submission date: 22/08/2013
Registration date: 22/08/2013
Last edited: 29/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Jocelyn Buly
Scientific

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

Email	jocelyn.buly@eoc.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Not specified
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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)
Study acronym	INTCLAPH
Study objectives	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(s)	13/LO/0753
Health condition(s) or problem(s) studied	Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Non-inflammatory Joint Disorders
Intervention	tbc, tbc
Intervention type	Other
Primary outcome measure	tbc; Timepoint(s): tbc
Secondary outcome measures	Not provided at time of registration
Overall study start date	15/08/2013
Completion date	15/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 45; UK Sample Size: 45
Key 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
Key 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
Date of first enrolment	15/08/2013
Date of final enrolment	15/01/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Epsom and St Helier University Hospitals NHS Trust

Carshalton
SM5 1AA
United Kingdom

Sponsor information

St George's University of London (UK)
University/education

Cranmer Terrace
London
SW17 0RE
England
United Kingdom

"ROR"	https://ror.org/040f08y74

Funders

Funder type

Charity

Orthopaedic Research UK; Grant Codes: 491
Private sector organisation / For-profit companies (industry)

Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

29/05/2020: No publications found.
12/01/2017: No publications found, verifying study status with principal investigator.