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Recruiting Phase 1, Phase 2 NCT07036003

Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)

Trial Parameters

Condition Knee Osteoarthritis (Knee OA)
Sponsor Dr. David Wasserstein
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 34
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-10-31
Completion 2028-07
Interventions
Somatropin (recombinant human growth hormone)bacteriostatic saline placebo

Brief Summary

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

Inclusion Criteria: * Between 18 - 65 years old. * Diagnosis of isolated knee osteoarthritis for greater than 6 months. Exclusion Criteria: * 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. * Known

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