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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06907121




Registration number
NCT06907121
Ethics application status
Date submitted
26/03/2025
Date registered
2/04/2025
Date last updated
2/04/2025

Titles & IDs
Public title
Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
Scientific title
Investigation of Intra-Articular Growth Hormone and Platelet-Rich Plasma on Joint Health in Adults with Knee and Ankle Arthritis Resistant to Treatment
Secondary ID [1] 0 0
INT-2025-02-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis Ankle 0 0
Arthritis Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma

Experimental: Treatment of Ankle Arthritis - Injection of 10 iu of Somatropin and Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic ankle. This will be administered with a 7-16 day buffer period between each injection. There will be three total injections for the study.

Experimental: Treatment of Knee Arthritis - Injection of 10 iu of Somatropin and Platelet-Rich Plasma conjunct via intra-articular injection of the arthritic knee. This will be administered with a 7-16 day buffer period between each injection. There will be three total injections for the study.


Treatment: Drugs: Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
Intervention will be an intra-articular injection of 10 units of HGH and 10 mL PRP conjunct. Three total injections/placements of HGH spaced 7 to 16 days apart on either the effected ankle or knee joint guided by ultrasound.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ankle mobility and functionality test with AOFAS scale
Timepoint [1] 0 0
Baseline, 3-months after final injection, 6-months after final injection
Primary outcome [2] 0 0
Knee mobility and functionality test with AKS scale
Timepoint [2] 0 0
Baseline, 3-months after final injection, 6-months after final injection
Secondary outcome [1] 0 0
MRI Imaging of the affected arthritic joint
Timepoint [1] 0 0
Baseline, 6-months after final injection
Secondary outcome [2] 0 0
Blood test for hormone
Timepoint [2] 0 0
Baseline, 2 hours after each injection

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 within 6 months of study application.
* 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 (<18 years of age or no radiographic evidence of closure of epiphyses).
* Pregnancy.
* Active infection at the injection site.
* Open soft tissue injury.
* Metabolic disorders known to adversely affect the skeleton (e.g. renal osteodystrophy or hypercalcemia), other than primary osteoporosis or diabetes.
* Over 70 years of age
* Unstable joint or maligned joint > 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dr Gordon Slater: Orthopaedic Surgeon - Potts Point
Recruitment postcode(s) [1] 0 0
2011 - Potts Point

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Integrant Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Technology, Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Gordon L Slater, Professor
Address 0 0
Integrant Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gordon L Slater, Prof
Address 0 0
Country 0 0
Phone 0 0
+61 418 721 380
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06907121