Case Series Study: Treatment of Osteochondral Defects in the Hip Using Microfracture Augmented with CelGro (Trademark) Collagen Matrix

Not Applicable

• Conditions: Cartilage defect hip; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616000464460
• Lead Sponsor: Orthocell Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-08
• Study Completion: 2019-06-27
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Male or female between 18-55 years of age
- Acetabular osteochondral defect (Outerbridge grade III or IV) measuring 2-8cm2
- Radiologically confirmed Tonnis grade < 2
- Able to comply with the requirements of the protocol, including post-treatment rehabilitation
- Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP

Exclusion Criteria

- Concomitant presence of femoral head chondral lesion (kissing lesion)
- Rheumatoid arthritis
- Dysplasia
- Femoral neck axial deviation
- Coxa profunda
- Protrusio acetabuli
- Active infection or systemic pathology including inflammatory joint disease, HIV, uncontrolled or poorly controlled diabetes, hepatitis or neoplastic disorders
- Known hypersensitivity to the study treatment or its excipients or known relevant medication allergy
- Female participant who is pregnant or lactating
- Known substance abuse
- Participation in another study with an investigational product within 3 months of visit 1
- Concurrent medical condition which precludes the administration of study treatment
- Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the Investigator, compromise the safety of the participant or the outcome of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability are measured through;<br>- Adverse events related to study treatment or procedures<br>- Additional surgical or significant medical intervention required as a result of treatment failure<br>-Presence or absence of systemic immune reactions or other systemic adverse event related to the study treatment. <br><br>Adverse events related to the study treatment may include, hip infection and allergic reaction to the scaffold. Persons highly sensitive to porcine material may react to the scaffold.<br><br>Adverse events related to arthroscopic hip surgery may include, discomfort and swelling in the groin, thigh, lower back and buttock regions. Rare adverse events related to hip surgery include; infection, temporary numbness in the groin and the standard risks of undergoing general anaesthesia. <br>[Enrolment, immediately prior to surgery, on a single visit occurring between days 7-14 post surgery and 6 weeks, and 6 and 12 months post surgery. ]

Secondary Outcome Measures

Name	Time	Method
Efficacy endpoint:<br><br>Pain measured by Visual Analogue Score (VAS)<br><br><br>[6 and 12 months post-surgery.];Quality of Life assessed using AQOL.[6 and 12 months post-surgery.<br>];Efficacy Endpoint:<br>Disability measured using the Modified Harris Hip Score and the International Hip Outcome Tool (iHOT-12)[6 and 12 months post-surgery];Time elapsed before participants are able to return to sporting activities, as documented by Investigator in participants medical notes. [6 and 12 months post-surgery.]