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 |
| Protocol serial number | 14799 |
| Sponsor | St George's University of London (UK) |
| Funder | Orthopaedic Research UK; Grant Codes: 491 |
- 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
Scientific
Cardiology, Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
| jocelyn.buly@eoc.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Not specified |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
tbc; Timepoint(s): tbc |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Epsom and St Helier University Hospitals NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/05/2020: No publications found.
12/01/2017: No publications found, verifying study status with principal investigator.
