Status:
NOT_YET_RECRUITING
Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
Lead Sponsor:
Integrant Pty Ltd
Collaborating Sponsors:
University of Technology, Sydney
Conditions:
Arthritis Ankle
Arthritis Knee
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This clinical study will evaluate the efficacy of intra-articular (IA) injection of growth hormone (HGH) and platelet-rich plasma (PRP) in adults with knee and ankle arthritis resistant to conventiona...
Detailed Description
This clinical study will evaluate the efficacy of intra-articular (IA) injection of growth hormone (HGH) and platelet-rich plasma (PRP) in adults with knee and ankle arthritis resistant to conventiona...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06907121
Start Date
June 1 2025
End Date
December 1 2027
Last Update
April 2 2025
Active Locations (1)
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1
Dr Gordon Slater: Orthopaedic Surgeon
Potts Point, New South Wales, Australia, 2011