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

Phase 2Active Not RecruitingNCT07036003

Dr. David Wasserstein34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Knee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions. * BMI of less than 20 or greater than 35. * Documented history of growth disorder of bones or connective tissue, type 1 or 2 diabetes, myopathy, cancer, endocrine disorder, severe hypertension (SBP \> 180) or rheumatologic disorder. * Pregnant or breastfeeding, or actively attempting to get pregnant. * Currently on hypoglycemic therapy, oral estrogen or glucocorticoid replacement therapy. * Would have difficulty with the self-injection schedule or other cognitive/ functional limitations. * Have taken creatine within 7 days before baseline. Potential participants will be given the option to pause their supplements and then re-screen if they are interested in the study, * Have taken anabolic steroids within 42 days (6 weeks) before baseline. Potential participants will be given the option to pause their supplements and then rescreen if they are interested in the study, * Vital signs or routine bloodwork outside of normal range.

Outcomes

Primary Outcomes

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

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

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.

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.

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.

Thigh circumference

Participant's measurements of function will be measured by their thigh circumference compared to the contralateral leg, and baseline.

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

Mid-calf circumference

Participant's measurements of function will be measured by their mid-calf circumference compared to the contralateral leg, and baseline.

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

Abdominal circumference

Participant's measurements of function will be measured by their abdominal circumference.

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

Range of motion of both knees

Participant's measurements of function will be measured by Range of motion of both knees.

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

6 Minute Walk Test (6MWT)

Participants' distance traveled in the span of 6 minutes will be measured on a treadmill (unit: total meters).

Time frame: At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment.

Activity Count

Participants' activity count will be measured using a fitness tracker (ActiGraph) worn around the ankle. The total time the fitness tracker is worn will be monitored by the device.

Time frame: From enrolment to the 12-week study visit.

Knee Injury and Osteoarthritis Score (KOOS)

Participants will be asked to complete the Knee Injury and Osteoarthritis Score (KOOS) questionnaire to measure their overall well-being. KOOS uses a Likert scale ranging from 0 (No problems) to 4 (Extreme problems).

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

20-Item Short Form Survey (SF-20)

Participants will be asked to complete the 20-Item Short Form Survey Instrument (SF-20) questionnaire which measures their overall well-being including their physical and social functioning.

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

Tegner Activity Scale

Participants will be asked to complete the Tegner Activity Scale questionnaire, which measures their level of activity. A 11-point scale (ranging from 0 - 10) is used where a higher score indicates higher level of activity.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes