Investigation of growth hormone for knee and ankle arthritis.
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
Integrant Pty Ltd
60 participants
Jun 7, 2025
Interventional
Conditions
Summary
The purpose of the study is to investigate the intra-articular injection of growth hormone in combination with a carrier for arthritis in the knee and ankle. The hypothesis of the study is the intra-articular injection of growth hormone will increase healing of arthritic or injured joints when compared to standard treatment. The patients are to be referred by their GP to be recruited to the private surgical clinic. The pain and mobility of the joints will be measured by using the American Orthopaedic Foot and Ankle Society (AOFAS) and American Knee Society (AKS) indexes to test the mobility of the ankle and knee respectively.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria7
- 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.
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Interventions
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.
Locations(1)
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ACTRN12625000243415