Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr. David Wasserstein
About this trial
The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan.
Participants will be asked to:
* Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks. * Complete questionnaires related to their knee pain and activities of daily living. * Provide blood tests. * Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.
Eligibility criteria
Qualifiers
Between 18 - 65 years old.
Diagnosis of isolated knee osteoarthritis for greater than 6 months.
Disqualifiers
Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral/tibial osteotomies, ligament repair/reconstruction, or cartilage transplantation. Patients with remote (>1 year) diagnostic arthroscopy, arthroscopic debridement, meniscectomy, or meniscal repair may be allowed to participate at the investigators' discretion.
Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with prior complete ligament tears will be excluded, patients with chronic partial thickness ligament tears or degenerative/complex meniscal tears (>6 months from injury) may be included at the investigators' discretion
Recent (less than 6 months) intra-articular injection into the involved knee.
High grade ligamentous knee injury.
Trial design
Treatments tested in this trial
- Somatropin (recombinant human growth hormone)
- bacteriostatic saline placebo
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dr. David Wasserstein
Lead sponsor
Sunnybrook Health Sciences Centre
Sponsor institution
Sunnybrook Research Institute
Collaborator
Source ClinicalTrials.gov