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NCT06220539: CARE
CAsting and REhabilitation Versus Supervised Neglect for Osteochondral Lesions of the Talus in the Pediatric Population
NA trial testing Casting and supervised rehabilitation in Cartilage Injury in 76 participants. Not yet recruiting.
1 July 2027
Quick facts
| Lead sponsor | Tristan Buck |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 1 February 2024 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 July 2027 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- Casting and supervised rehabilitation
Conditions studied
- Cartilage Injury — all drugs for Cartilage Injury →
- Orthopedic Disorder — all drugs for Orthopedic Disorder →
- Skeletal Injury — all drugs for Skeletal Injury →
- Rehabilitation — all drugs for Rehabilitation →
Sponsor
Tristan Buck
Who can join
Adults 4 to 18, any sex, with Cartilage Injury or Orthopedic Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale: OCLs (osteochondral lesions) of the talus can be congenital or can occur after trauma or in patients with juvenile idiopathic arthritis (JIA). The main complaint of an OCL is pain during weightbearing activities. Therefore, these lesions have significant impact on the health status of patients. Objective: The aim of this study is to optimize the treatment for skeletally immature patients with an osteochondral lesion. The hypothesis is that a period of immobilization and supervised rehabilitation will lead to better clinical and radiological outcomes compared with standard care which is a ''skill-full'' neglect. Study design: Observational comparative study Study population: Skeletally immature children with an osteochondral lesion of the talus diagnosed on CT. Intervention: Patients in the intervention group will undergo an 8-week period of casting and walking on crutches. Afterwards, they will receive a protocolled period of rehabilitation under supervision of a physical therapist. The control group will have the standard care as treatment. Main study parameters/endpoints: the main study outcome is the difference between the two groups on the OxAFQ-C. Secondary study outcomes are radiologic changes in terms of morphology and lesion size, NRS during weight bearing and quality of life measured with a Peds-QL, EQ-5D-y and AAS. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden that patients will have is mainly the time that they have to spent on fulfilling the questionnaires.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06220539
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cartilage Injury
Currently open trials in the same condition.
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- NCT04184687 — The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction · NA · recruiting
- NCT03873545 — Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06220539 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tristan Buck
- Last refreshed: 24 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06220539.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing