A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy

Hospital for Special Surgery (HSS)

Status and phase: Withdrawn; Phase 2

Conditions: Tendinopathy

Treatments: Drug: Somatropin; Drug: Bacteriostatic saline; Other: Progressive exercise program; Procedure: Patellar tendon biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02597660

HUM00107019

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Drug: Somatropin

Active Comparator group

Description:

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.

Treatment:

Other: Progressive exercise program

Procedure: Patellar tendon biopsy

Drug: Somatropin

Drug: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Progressive exercise program

Drug: Bacteriostatic saline

Procedure: Patellar tendon biopsy