Evaluation of Recombinant Growth Hormone Therapy to Prevent Muscle Atrophy in Patients With Anterior Cruciate Ligament Tears
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op
研究概览
简要总结
Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after patients return to full activity and can place them at considerable risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic interventions to prevent muscle atrophy is needed to advance the care of patients who suffer from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an important role in promoting muscle growth and protecting muscle from atrophy. While GH therapy has shown promise in protecting immobilized muscle from various models of disuse atrophy, it remains unknown whether GH can help to restore strength and protect against the loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe return to play of patients that suffer ACL tears, and help to prevent the long-term OA and reduction in quality of life that occur after these traumatic knee injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males between the ages of 18 and 35
- •Have acute unilateral complete ACL tears with or without bucket handle medial meniscus tears that occurred within the past 6 months
- •Consent to undergo an ACL reconstruction by an orthopaedic surgeon using a patellar tendon or hamstring autograft
- •Will be performing supervised post-operative rehabilitation at UMHS MedSport at Dominos Farms
排除标准
- •Patients who are undergoing a revision ACL reconstruction
- •Had a previous injury to the involved knee
- •Have an allergy to recombinant GH
- •Have a BMI<20 or >35
- •Have a growth disorder of bones or connective tissue, type 1 diabetes mellitus, type 2 diabetes mellitus, or who have a history of carpal tunnel syndrome, trigger finger, myopathy, cancer, endocrine disorder, hypertension or rheumatologic disorder.
- •Systolic blood pressure >140mm Hg or diastolic blood pressure >90mm Hg, or with resting heart rate >110 BPM or <40 BPM at screening.
- •Additionally, because GH is currently listed as a banned substance by the World Anti-Doping Agency (WADA), National Collegiate Athletics Association (NCAA) and most professional sports agencies, we will exclude patients who are current collegiate, professional or elite athletes.
研究组 & 干预措施
Somatropin
Somatropin of rDNA origin
干预措施: Somatropin (Drug)
Placebo
A placebo vehicle that contains somatropin diluent but no active hormone.
干预措施: Placebo (Drug)
结局指标
主要结局
Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op
时间窗: at 26 wks post-op
Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
次要结局
- Normalized Quadriceps Volume (L) at 26 Weeks Post-op(at 26 weeks post-op)
- Normative Isokinetic Extension (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- Absolute Isometric Extension (Nm) at 26 Weeks Post-op(at 26 weeks post-op)
- VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op(at 26 weeks post-op)
- Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op(at 26 weeks post-op)
- Absolute Isometric Extension (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- Absolute Isometric Flexion (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline)(at pre-op (baseline))
- VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op(at 26 weeks post-op)
- International Knee Document Committee (IKDC) at Pre-op (Baseline)(at pre-op (baseline))
- KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline)(at pre-op (baseline))
- Normative Isometric Extension (Nm) at 26 Weeks Post-op(at 26 weeks post-op)
- Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op(at 26 weeks post-op)
- Absolute Isometric Flexion (Nm) at 26 Weeks Post-op(at 26 weeks post-op)
- VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline)(at pre-op (baseline))
- International Knee Documentation Committee (IKDC) up to 26 wk Post-op(up to 26 wk post-op)
- KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline)(at pre-op (baseline))
- Normative Isometric Extension (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- Normative Isometric Flexion (Nm) at 26 Weeks Post-op(at 26 weeks post-op)
- Absolute Isokinetic Extension (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- Absolute Isokinetic Extension (Nm) at 26 wk Post-op(at 26 wk post-op)
- Normative Isokinetic Flexion (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- Normative Isometric Flexion (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline)(at pre-op (baseline))
- The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op(at 26 weeks post-op)
- KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op(at 26 weeks post-op)
- KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op(at 26 weeks post-op)
- KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op(at 26 weeks post-op)
- Absolute Quadricep Volume (L) at 26 Week Post-op(at 26 week post-op)
- Absolute Quadriceps Volume (L) at Pre-op (Baseline)(at pre-op (baseline))
- Absolute Hamstring Volume (L) at 26 Weeks Post-op(at 26 weeks post-op)
- Hyaluronic Acid at -1 and 5 Weeks Post-op(Area under the curve between -1 and 5 weeks post-op)
- KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op(at 26 weeks post-op)
- KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline)(at pre-op (baseline))
- Absolute Hamstring Volume (L) at Pre-op (Baseline)(at pre-op (baseline))
- Normalized Hamstring Volume (L) at 26 Weeks Post-op(at 26 weeks post-op)
- Myostatin at -1 and 5 Weeks Post-op(Area under the curve between -1 and 5 weeks post-op)
- KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline)(at pre-op (baseline))
- KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline)(at pre-op (baseline))
- Normalized Quadriceps Volume (L) at Pre-op (Baseline)(at pre-op (baseline))
- Normalized Hamstring Volume (L) at Pre-op (Baseline)(at pre-op (baseline))
- MMP3 at -1 and 5 Weeks Post-op(Area under the curve between -1 and 5 weeks post-op)
- Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op(Area under the curve between -1 and 5 weeks post-op)
研究者
Christopher Mendias, PhD, ATC
Associate Professor
University of Michigan