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Efficacy of BST-CarGel in Treating Chondral Lesions of the Hip

NCT02540200 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-02-07

No results posted yet for this study

Summary

Hip pain in young patients is difficult to diagnose and treat. However, with advanced imaging techniques and surgical method, the investigators are able to identify hip cartilage lesions as a cause for the hip pain. MR (magnetic resonance) arthrography is the best imaging modality to diagnose chondral lesions of the hip, but it occasionally miss the pathology, thus necessitating a more accurate and invasive means of diagnosis. Consequently, hip arthroscopy is increasingly used for both diagnosis and treatment for hip cartilage pathology.

Microfracture is a means of stimulating bone marrow, and is a standard treatment for small chondral lesions. This procedure has shown to result in excellent functional and anatomical outcomes. Microfracture is now recognized as a standard treatment for cartilage lesions in the knee, and recently the indications of this technique extended to hip pathology.

The BST-CarGel device (Piramal Life Sciences, Bio-Orthopaedic Division) is based on the patented technology for cartilage repair. BST-Gel comprised of the buffer beta-glycerophosphate and chitosan, which is a well-studied natural material that is biocompatible and appropriate for its use as a scaffold to assist in cartilage repair. BST-Gel is mixed with the patient's whole blood and delivered to a surgically prepared cartilage lesion in conjunction with bone marrow stimulation. The BST-CarGel/blood mixture solidifies in the cartilage lesion and provides a three-dimensional scaffold for the repair process. This product has shown to result in superior chondral lesion repair when compared to the bone marrow stimulation alone.

The current study will collect data through standard of care practice when BST-CarGel in conjunction with a bone marrow stimulation technique is used for the treatment of focal cartilage lesions in the hip. In addition, these patients in the study group will be compared with the group o patients who undergo the bone marrow stimulation technique alone. The efficacy of BST-CarGel in conjunction with microfracture for cartilage lesions in the knee has been shown in previous studies. Additional research is required to expand knowledge and develop treatment guidelines for the treatment of the cartilage lesions in the hip using BST-CarGel. As the BST-CarGel improves the results of the bone marrow stimulation techniques without increasing the risks of the procedure, this device can be very beneficial in the case of cartilage lesions in the hip.

Conditions

  • Disorder of Hip Region

Interventions

DEVICE

BST-CarGel

BST-CarGel is a scaffolding material after microfracture treatment is performed in order to treat the chondral lesions. It assists in the repair process by stabilizing the clot in the cartilage lesion via adhesion and inhibition of clot retraction.

PROCEDURE

Microfracture

It is a bone marrow stimulation technique, and the standard treatment for chondral lesions of the hip joint.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Ivan Wong, MD · Nova Scotia Health Authority

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02540200 on ClinicalTrials.gov