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

NCT02540200 | Withdrawn

• 1 other identifier: NSHA-RS/2016-118
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety (any potential side effects)

  Patients will be followed up for a total of 1 year after the operation, and any potential side effects will be recorded and reviewed

Secondary Outcomes (4)

• Lesion repair outcome (amount of repair measured on the MRI or magnetic resonance imaging)

  MRI will be performed at 1 year post-intervention

• VAS - Visual Analog Pain Score

  Patients will fill out the questionnaires at 1 month, 6 months, and 12 months post-intervention during their clinic visit

• NAHS - Non Arthritic Hip Score

  Patients will fill out the questionnaires at 1 month, 6 months, and 12 months post-intervention during their clinic visit

• iHOT-33 - International Hip Outcome Tool

  Patients will fill out the questionnaires at 1 month, 6 months, and 12 months post-intervention during their clinic visit

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

The patients undergo standard bone marrow stimulation technique (i.e. microfracture) for the treatment of their chondral lesions of the hip. This is currently the standard treatment for this condition.

Procedure: Microfracture

BST-CarGel

EXPERIMENTAL

In addition to undergoing the standard intervention with microfracture, BST-CarGel (the device of interest for the study) is applied during the intervention.

Device: BST-CarGel; Procedure: Microfracture

Interventions

BST-CarGel DEVICE

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.

BST-CarGel

Microfracture PROCEDURE

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

BST-CarGel; Standard treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A body mass index less than or equal to 30 kg/m2
• An age from 18 to 40 years
• Alpha angle of \> 55 degree on plain AP (anterior-posterior) pelvis radiograph.
• The study patient agrees to follow the recommended physiotherapy program, including exercises to complete at home
• The study patient has understood and signed the informed consent form approved by the Research Ethics Board prior to any study protocol evaluations and is committed to complete the study as defined in this protocol and in the study patient's informed consent form.
• MRI-identified delamination will be included in the CarGel group
• Lesion size greater than 2cm2 on the intraoperative measurement.

You may not qualify if:

• Any medical conditions which in the opinion of the investigator, makes the study patient unable to complete the study or is likely to interfere with the assessment of safety and efficacy of the BST-CarGel medical device
• Any coagulation disorders of the blood or those receiving anticoagulant therapy
• Rheumatoid arthritis, osteoarthritis and crystal arthropathies such as gout, pseudogout, etc., and any arthritic changes of the joint
• Chondral damage opposing the cartilage lesion (kissing lesions)
• Known allergy to chitosan or known hypersensitivity to crustaceans such as shrimp, lobster and crab
• Any general pathology that might prevent the collection of data on an extended duration.
• Grade 2 or higher chondral changes in intraoperative findings

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Ivan Wong, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 3, 2015
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share