Health TrialsbyHealthPanel

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

ConditionsKnee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Somatropin (recombinant human growth hormone)

    Drug

    Study participants will deliver Somatropin via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks at a dose of 0.5mg/day per body surface area (0.5mg/m2/day).

  • bacteriostatic saline placebo

    Drug

    Study participants will deliver bacteriostatic saline via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks in an identical delivery device to the experimental arm.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Recombinant Human Growth Hormone (rHGH)Experimental treatment 1 intervention
Group B: Bacteriostatic SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of the medication administration

Participant adheres to self-administration of injections once daily for 6 weeks.

Time frame
6 weeks after treatment begins.

Secondary outcomes

1

Clinical Outcomes: knee extension strength

Participants' knee extension strength will be measured using HUMAC Norm Extremity Strength Testing system.

Time frame
At 6 weeks and 24 months time points after enrolment
2

Clinical Outcome: knee flexion strength

Participants' knee flexion strength will be measured using HUMAC Norm Extremity Strength Testing system.

Time frame
At 24 months after enrolment.
3

Clinical Outcomes: thigh muscle strength

Participants' thigh muscle strength will be measured through hip flexion, hip abduction and knee flexion using a goniometer.

Time frame
At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.
4

Clinical Outcomes: Kinematic Gait Analysis

Participants' kinematic gait analysis will be measured with single/ two leg hop/jump and single/ two leg squat, using the Theia Markerless system before and after treatment.

Time frame
At baseline, 6 weeks and 6 months study visits.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. David Wasserstein

Lead sponsor

Sunnybrook Health Sciences Centre

Sponsor institution

Sunnybrook Research Institute

Collaborator

Source ClinicalTrials.gov
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