Loading... Please wait...Posted by Integrant Pty Ltd on 5th Dec 2025
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 conventional treatment.
The study, sponsored by Integrant Pty Ltd and led by Prof. Gordon Slater, aims to determine whether IA HGH injections can enhance cartilage regeneration and joint healing.
The study will recruit 60 patients who will receive three IA injections of HGH and PRP spaced 7-16 days of each other.
Outcomes will be assessed using AOFAS and AKS scoring systems at 3- and 6-months post-treatment.
The study hypothesizes that HGH will increase healing of arthritic or injured joints compared to standard treatment, potentially providing a non-surgical alternative for patients with treatment-resistant arthritis.
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 conventional treatment. The HGH used will be approved by ethics and comes from a reputable chinese manufacturer called GenSci. The PRP Tubes are supplied by Integrant being a TGA approved device.
The study, sponsored by Integrant Pty Ltd and led by Prof. Gordon Slater, aims to determine whether IA HGH injections can enhance cartilage regeneration and joint healing. This study will be completed within Prof Gordon Slater's private clinic in a clean environment.
The study will recruit 60 patients who will receive three IA injections of HGH and PRP over 7-16 days. The inclusion criteria includes: 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. The exclusion criteria include: 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.
Outcomes will be assessed using AOFAS and AKS scoring systems at 3- and 6-months post-treatment. A secondary outcome of the study includes having a blood test before each injection intervention and 2 hours after each injection. This is to test for HGH within the blood of the patient.
The study hypothesizes that HGH will increase healing of arthritic or injured joints compared to standard treatment, potentially providing a non-surgical alternative for patients with treatment-resistant arthritis.
This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.
To learn more, please see the
Name: Gordon L Slater, Prof
Phone Number:
Email:
Name: Zadane F Bachmid
Phone Number:
Email:
Inclusion Criteria:
Exclusion Criteria:
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Arms and Interventions
| Participant Group/Arm |
Intervention/Treatment |
|---|---|
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.
|
|
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.
|
|
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
| Ankle mobility and functionality test with AOFAS scale | The AOFAS (American Orthopaedic Foot and Ankle Society) scale is a widely used outcome measure for ankle and hindfoot conditions, including ankle arthritis, assessing pain, function, and alignment, with scores ranging from 0 to 100, where higher scores indicate better function. | Baseline, 3-months after final injection, 6-months after final injection |
| Knee mobility and functionality test with AKS scale | The AKS is a validated instrument used to assess patient outcomes after surgical knee interventions, evaluating both the knee joint itself (Knee Score) and functional ability (Function Score). | Baseline, 3-months after final injection, 6-months after final injection |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
| MRI Imaging of the affected arthritic joint | The MRI scans will be evaluated by a radiologist blinded to the treatment allocation to assess changes in: Cartilage volume and thickness, Synovial inflammation (e.g., synovitis), Bone marrow edema, Osteophyte formation, Other structural changes relevant to arthritis progression | Baseline, 6-months after final injection |
| Blood test for hormone | Blood tests to check for growth hormone within the blood system. | Baseline, 2 hours after each injection |
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