Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000243415p
Ethics application status
Not yet submitted
Date submitted
11/02/2025
Date registered
3/04/2025
Date last updated
3/04/2025
Date data sharing statement initially provided
3/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of growth hormone for knee and ankle arthritis.
Scientific title
Investigation of Ultrasound Guided Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults with Ankle/Knee arthritis Resistant to Treatment
Secondary ID [1] 313907 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle Arthritis 336599 0
Knee Arthritis 336733 0
Condition category
Condition code
Musculoskeletal 333104 333104 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intra-articular injection of growth hormone and platelet-rich plasma (PRP) within the knee and ankle. International Non-Proprietary name is somatropin, or recombinant human growth hormone. One dosage is a 10 IU intra-articular injection of somatropin and 10mL of PRP.
Total of 3 injections of somatropin and PRP conjunct. The patient will receive the injection on either ankle or knee joint, guided by an ultrasound to accurately get the joint. Injection of the somatropin and PRP will happen concurrently, with the injections spaced 7 to 16 days apart. This trial will occur within a private surgical clinic with the intervention administered by the Orthopaedic Surgeon. A session attendance checklist using a practice management software, Clinic to Cloud, will monitor the adherence to the intervention.
Intervention code [1] 330500 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340640 0
Ankle Functionality and quality of life assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) Scale.
Timepoint [1] 340640 0
Baseline, 3, and 6 Months (primary timepoint) following final injection
Primary outcome [2] 340794 0
Knee Functionality and quality of life assessed using the American Knee Society (AKS) Score.
Timepoint [2] 340794 0
Baseline, 3, and 6 Months (primary timepoint) following final injection
Secondary outcome [1] 444690 0
Level of Human Growth Hormone (hGH) in bloodstream after injection.
Timepoint [1] 444690 0
Before injection, 2 hours after each of three injections

Eligibility
Key inclusion criteria
Ankle/Knee arthritis resistant to treatment in GP clinic setting.
Significant Ankle/Knee cartilage injury can be shown on MRI scan or weight bearing X-Ray.
Able to give informed consent to participation in a clinical trial.
Able to commit to attending clinic for follow up.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A known hypersensitivity to any of the components of the product.
Cancer diagnosis or suspicion.
Resected or active tumor.
Skeletally immature ( 5%
No cartilage detected in the joint (bone on bone in medical imaging)
Unable to give informed consent.
Unable to commit to attend clinic for follow up.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Measurement of movement and pain by using the use of the AOFAS scale and AKS scale supported by studies using similar indexes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/06/2025
Actual
Date of last participant enrolment
Anticipated
5/07/2025
Actual
Date of last data collection
Anticipated
6/09/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318380 0
Commercial sector/Industry
Name [1] 318380 0
Integrant Pty Ltd
Country [1] 318380 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integrant Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320782 0
None
Name [1] 320782 0
None
Address [1] 320782 0
Country [1] 320782 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317012 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317012 0
Ethics committee country [1] 317012 0
Australia
Date submitted for ethics approval [1] 317012 0
19/05/2025
Approval date [1] 317012 0
Ethics approval number [1] 317012 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139730 0
Prof Gordon Slater
Address 139730 0
Dr Gordon Slater: Orthopaedic Surgeon, 5 Ward Avenue, Potts Point, 2011, NSW
Country 139730 0
Australia
Phone 139730 0
+61 412 621 732
Fax 139730 0
Email 139730 0
[email protected]
Contact person for public queries
Name 139731 0
Zadane Bachmid
Address 139731 0
Integrant Pty Ltd, 5 Ward Avenue, Potts Point, 2011, NSW
Country 139731 0
Australia
Phone 139731 0
+61 408 028 609
Fax 139731 0
Email 139731 0
[email protected]
Contact person for scientific queries
Name 139732 0
Zadane Bachmid
Address 139732 0
Integrant Pty Ltd, 5 Ward Avenue, Potts Point, 2011, NSW
Country 139732 0
Australia
Phone 139732 0
+61 408 028 609
Fax 139732 0
Email 139732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.