A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
- Conditions
- Tendinopathy
- Interventions
- Drug: Bacteriostatic salineOther: Progressive exercise programProcedure: Patellar tendon biopsy
- Registration Number
- NCT02597660
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug: Somatropin Progressive exercise program 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. Drug: Somatropin Patellar tendon biopsy 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. Drug: Placebo Bacteriostatic saline 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. Drug: Placebo Progressive exercise program 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. Drug: Placebo Patellar tendon biopsy 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. Drug: Somatropin 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.
- Primary Outcome Measures
Name Time Method Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment Week 1 to week 26
- Secondary Outcome Measures
Name Time Method 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 Bilateral biopsies will be taken, and the expression of genes will be measured with microarrays or RNA-sequencing
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 Five point assessment scale of tendon quality (0 Normal, Normal tendon structure; 1 Mild, Ill-defined abnormal hypoechogenicity; 2 Moderate, Well-defined abnormal hypoechogenicity; 3 Severe, Well-defined abnormal hypoechogenicity and anechoic clefts; 4 Complete, Full-width tendon disruption or tear)
Electron micrographs of patellar tendon biopsy sample Week 26 Bilateral biopsies will be taken, and the size (measured in squared nanometers) will be measured
Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score Week 1, 2, 3, 4, 9, 14, 26
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States