A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment
研究概览
简要总结
Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and reduced function in patients. Standard treatment options for patellar tendinopathies include non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy, eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these therapies and return to normal activity levels, and recurrence rates for those who do respond are unacceptably high. Many patients who fail to respond display persistent degenerative changes on imaging studies suggesting a failure to regenerate the pathological tissue. Developing new therapies that can directly promote the synthesis of new, healthy extracellular matrix tissue could therefore address an important therapeutic need and make a substantial improvement in our ability to effectively treat patellar tendinopathy and reduce recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown to increase protein synthesis and matrix production when delivered directly into the tendon. This study will evaluate the ability of somatropin to improve clinical outcomes and tissue quality in patients with chronic tendinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 18 - 50
- •Patients with a greater than 3 month history of anterior knee pain
- •Patients with a confirmed diagnosis of patellar tendinopathy (confirmation by ultrasonography demonstrating local anterior-posterior thickening of the tendon of at least 1mm compared with the mid-tendon level, and a hypo-echoic area)
排除标准
- •Patients who have received corticosteroid injections within 12 months
- •Patients who have full-width disruptions of the patellar tendon
- •Patients who have undergone previous knee surgery or intraarticular injury
- •Patients who have have arthritis (Kellgren and Lawrence grade 2 or higher), open growth plates, diabetes, cardiovascular disease, history of cancer or any major medical illnesses or endocrine disorders
- •Patients with a body mass index greater than 35
- •Women who are pregnant or planning to become pregnant
- •Patients who are current collegiate, professional or elite athletes, or are participating in sports organizations that currently ban the use of somatropin
研究组 & 干预措施
Drug: Somatropin
Under ultrasound guidance, patients will receive an injection of somatropin (0.1mg in a volume of 0.2mL of bacteriostatic saline) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
干预措施: Somatropin (Drug)
Drug: Somatropin
Under ultrasound guidance, patients will receive an injection of somatropin (0.1mg in a volume of 0.2mL of bacteriostatic saline) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
干预措施: Progressive exercise program (Other)
Drug: Somatropin
Under ultrasound guidance, patients will receive an injection of somatropin (0.1mg in a volume of 0.2mL of bacteriostatic saline) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
干预措施: Patellar tendon biopsy (Procedure)
Drug: Placebo
Under ultrasound guidance, patients will receive an injection of 0.2mL of bacteriostatic saline (which is an equivalent volume of diluent used in the active comparator arm) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
干预措施: Bacteriostatic saline (Drug)
Drug: Placebo
Under ultrasound guidance, patients will receive an injection of 0.2mL of bacteriostatic saline (which is an equivalent volume of diluent used in the active comparator arm) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
干预措施: Progressive exercise program (Other)
Drug: Placebo
Under ultrasound guidance, patients will receive an injection of 0.2mL of bacteriostatic saline (which is an equivalent volume of diluent used in the active comparator arm) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
干预措施: Patellar tendon biopsy (Procedure)
结局指标
主要结局
Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment
时间窗: Week 1 to week 26
次要结局
- Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test(Week 1, 2, 3, 4, 9, 14, 26)
- Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Short Form Global Health Scale(Week 1, 2, 3, 4, 9, 14, 26)
- Gene expression of patellar tendon biopsy sample(Week 26)
- Change in patient completed visual analog scale (VAS) of knee pain levels(Week 1, 2, 3, 4, 9, 14, 26)
- Ultrasound assessment of patellar tendon quality(Weeks 1, 14, 26)
- Electron micrographs of patellar tendon biopsy sample(Week 26)
- Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score(Week 1, 2, 3, 4, 9, 14, 26)