Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000464460
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
8/04/2016
Date last updated
27/10/2022
Date data sharing statement initially provided
27/10/2022
Date results information initially provided
27/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Case Series Study: Treatment of Osteochondral Defects in the Hip Using Microfracture Augmented with CelGro (Trademark) Collagen Matrix
Scientific title
Case Series Study: Treatment of Osteochondral Defects in the Hip Using Microfracture Augmented with CelGro (Trademark) Collagen Matrix
Secondary ID [1] 288892 0
CG-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cartilage defect hip 298197 0
Condition category
Condition code
Musculoskeletal 298356 298356 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a single autologous Matrix-Induced Chondrogenesis (AMIC) procedure conducted by an orthopaedic surgeon. AMIC is an enhanced version of the original microfracture technique in which a type I/III collagen matrix (Chondro-Gide, Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration. AMIC is an effective treatment for chondral lesions of the knee, ankle and hip, and can be performed arthroscopically, reducing total treatment time and minimising morbidity. The procedure takes between 1-2 hours, inclusive of recovery time.

A single CelGro (Trademark) membrane will be used in the AMIC procedure. CelGro (Trademark) is a type I/III collagen matrix obtained by a standardised, controlled manufacturing process. The collagen is of porcine origin and is carefully purified to remove foreign DNA and other substances that could provoke immunogenic reactions. CelGro (Trademark) has a bilayer structure with a porous side that allows for the ingrowth of cells. The scaffold consists of natural collagen without further cross-linking or chemical additives. CelGro (Trademark) is delivered sterile in a sealed pouch and presents as a white to off-white sheet with both a smooth and slightly rougher surface.
Intervention code [1] 294349 0
Treatment: Devices
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297834 0
Safety and tolerability are measured through;
- Adverse events related to study treatment or procedures
- Additional surgical or significant medical intervention required as a result of treatment failure
-Presence or absence of systemic immune reactions or other systemic adverse event related to the study treatment.

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.

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.
Timepoint [1] 297834 0
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 [1] 322371 0
Efficacy endpoint:

Pain measured by Visual Analogue Score (VAS)
Timepoint [1] 322371 0
6 and 12 months post-surgery.
Secondary outcome [2] 322474 0
Quality of Life assessed using AQOL.
Timepoint [2] 322474 0
6 and 12 months post-surgery.
Secondary outcome [3] 322598 0
Efficacy Endpoint:
Disability measured using the Modified Harris Hip Score and the International Hip Outcome Tool (iHOT-12)
Timepoint [3] 322598 0
6 and 12 months post-surgery
Secondary outcome [4] 322599 0
Time elapsed before participants are able to return to sporting activities, as documented by Investigator in participants medical notes.
Timepoint [4] 322599 0
6 and 12 months post-surgery.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/05/2016
Actual
27/03/2017
Date of last participant enrolment
Anticipated
1/12/2019
Actual
29/05/2018
Date of last data collection
Anticipated
1/12/2020
Actual
27/06/2019
Sample size
Target
25
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10325 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment postcode(s) [1] 21993 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 293246 0
Commercial sector/Industry
Name [1] 293246 0
Orthocell Ltd
Country [1] 293246 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Ltd.
Address
Building 191
Murdoch University
South Street, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 292048 0
None
Name [1] 292048 0
Address [1] 292048 0
Country [1] 292048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294724 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 294724 0
Research Governance Unit St Vincent's Hospital 41 Victoria Parade FITZROY VIC 3065
Ethics committee country [1] 294724 0
Australia
Date submitted for ethics approval [1] 294724 0
16/03/2016
Approval date [1] 294724 0
28/08/2016
Ethics approval number [1] 294724 0
HREC-D 045/16

Summary
Brief summary
Articular cartilage is aneural, avascular and has limited capacity for self-repair. Articular cartilage defects pre-dispose patients to developing osteoarthritis, and if left un-treated, damage can become so severe that joint replacement is indicated. Autologous Matrix-Induced Chondrogenesis (AMIC) is an enhanced version of the original microfracture technique, in which a type I/III collagen matrix (Chondro-Gide, Registered Trademark) is placed over the cartilage defect to stabilise the fragile bone marrow cell infiltrate and provide infrastructure for tissue repair and regeneration.

Currently, the majority of commercially available collagen membranes are manufactured in Europe or the USA from locally-produced source material. Australian-sourced biological materials are valued due to the historically low rate of zoonotic infectious diseases and absence of transmissible spongiform encephalitis. CelGro (Trademark) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Western Australia, eliminating disease transmission concerns associated with foreign products.

This study will use CelGro (Trademark) as the collagen matrix in AMIC treatment for osteochondral defect in the hip.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64826 0
Mr John O'Donnell
Address 64826 0
St Vincent's Hospital Melbourne
Department of Orthopaedic Surgery
41 Victoria Parade
Fitzroy VIC 3065
Country 64826 0
Australia
Phone 64826 0
+61 3 94216133
Fax 64826 0
Email 64826 0
admin@johnodonnell.com.au
Contact person for public queries
Name 64827 0
John O'Donnell
Address 64827 0
St Vincent's Hospital Melbourne
Department of Orthopaedic Surgery
41 Victoria Parade
Fitzroy VIC 3065
Country 64827 0
Australia
Phone 64827 0
61 3 9421 6133
Fax 64827 0
Email 64827 0
admin@johnodonnell.com.au
Contact person for scientific queries
Name 64828 0
Clair Lee
Address 64828 0
Orthocell Ltd
Building 191, Murdoch University
South Street,
Murdoch WA 6150
Country 64828 0
Australia
Phone 64828 0
61 8 9360 2888
Fax 64828 0
61 8 9360 2899
Email 64828 0
clair@orthocell.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Final, de-identified individual efficacy and safety data listings.
When will data be available (start and end dates)?
After final publication, no end date.
Available to whom?
Researchers who provide a scientifically and methodologically sound research proposal with Human Research Ethics Committee approval, as assessed on a case-by-case basis.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Subject to approval by the PI and Sponsor.

Email: luke.hanrahan@orthocell.com.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.