Investigation of Growth Hormone and Platelet-Rich Plasma on Joint Health
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIntegrant Pty Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Intra-Articular Injection of Growth Hormone and Platelet-Rich Plasma
DrugIntervention 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Treatment of Ankle ArthritisExperimental treatment 1 intervention
Group B: Treatment of Knee ArthritisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 3-months after final injection, 6-months after final injection2
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).
Time frame
Baseline, 3-months after final injection, 6-months after final injectionSecondary outcomes
1
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
Time frame
Baseline, 6-months after final injection2
Blood test for hormone
Blood tests to check for growth hormone within the blood system.
Time frame
Baseline, 2 hours after each injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Integrant Pty Ltd
Lead sponsor
University of Technology, Sydney
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: