Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02597660
Recruitment Status : Withdrawn (PI decided not to enroll)
First Posted : November 5, 2015
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tendinopathy Drug: Somatropin Drug: Bacteriostatic saline Other: Progressive exercise program Procedure: Patellar tendon biopsy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Active Comparator: 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.
Drug: Somatropin
Active drug
Other Names:
  • Growth hormone
  • Human growth hormone

Other: Progressive exercise program
Over a 12 week period beginning at the second study visit patients will perform a standard of care eccentric exercise training regime. Each session consists of three bilateral exercises: leg press, back squat, and hack squat. Subjects will complete four sets in each exercise with a 2-3 minute rest between sets. The repetitions/loads are: 15 repetition maximum (RM) week 1, 12RM weeks 2-3, 10RM weeks 4-5, 8RM weeks 6-8 and 6RM weeks 9-12. All exercises are performed from complete 0º to 90º of knee flexion and back again. Each of the eccentric and concentric phases will occur over a period of 3 seconds, respectively for a total of 6 seconds per contraction.

Procedure: Patellar tendon biopsy
Bilateral biopsies will be performed on an elective basis, although the investigators will aim to have 8 subjects in each group receive the biopsy. Biopsies will be obtained at the 26 week time point. The data obtained from the biopsy will help address the mechanism behind observed changes in outcome scores, physical measurements or imaging studies. The biopsy will be performed under ultrasound guidance and using sterile technique with a disposable 14G, 2cm biopsy instrument.

Placebo Comparator: 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.
Drug: Bacteriostatic saline
Placebo, the diluent used to reconstitute somatropin
Other Names:
  • Saline
  • 0.9% NaCl

Other: Progressive exercise program
Over a 12 week period beginning at the second study visit patients will perform a standard of care eccentric exercise training regime. Each session consists of three bilateral exercises: leg press, back squat, and hack squat. Subjects will complete four sets in each exercise with a 2-3 minute rest between sets. The repetitions/loads are: 15 repetition maximum (RM) week 1, 12RM weeks 2-3, 10RM weeks 4-5, 8RM weeks 6-8 and 6RM weeks 9-12. All exercises are performed from complete 0º to 90º of knee flexion and back again. Each of the eccentric and concentric phases will occur over a period of 3 seconds, respectively for a total of 6 seconds per contraction.

Procedure: Patellar tendon biopsy
Bilateral biopsies will be performed on an elective basis, although the investigators will aim to have 8 subjects in each group receive the biopsy. Biopsies will be obtained at the 26 week time point. The data obtained from the biopsy will help address the mechanism behind observed changes in outcome scores, physical measurements or imaging studies. The biopsy will be performed under ultrasound guidance and using sterile technique with a disposable 14G, 2cm biopsy instrument.




Primary Outcome Measures :
  1. Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment [ Time Frame: Week 1 to week 26 ]

Secondary Outcome Measures :
  1. Change in patient completed visual analog scale (VAS) of knee pain levels [ Time Frame: Week 1, 2, 3, 4, 9, 14, 26 ]
  2. Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score [ Time Frame: Week 1, 2, 3, 4, 9, 14, 26 ]
  3. Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test [ Time Frame: Week 1, 2, 3, 4, 9, 14, 26 ]
  4. Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Short Form Global Health Scale [ Time Frame: Week 1, 2, 3, 4, 9, 14, 26 ]
  5. Ultrasound assessment of patellar tendon quality [ Time Frame: 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)

  6. Electron micrographs of patellar tendon biopsy sample [ Time Frame: Week 26 ]
    Bilateral biopsies will be taken, and the size (measured in squared nanometers) will be measured

  7. Gene expression of patellar tendon biopsy sample [ Time Frame: Week 26 ]
    Bilateral biopsies will be taken, and the expression of genes will be measured with microarrays or RNA-sequencing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597660


Locations
Layout table for location information
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Layout table for investigator information
Principal Investigator: Christopher L Mendias, PhD, ATC Hospital for Special Surgery, New York
Publications:

Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02597660    
Other Study ID Numbers: HUM00107019
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital for Special Surgery, New York:
patellar tendinopathy
somatropin
jumper's knee
Additional relevant MeSH terms:
Layout table for MeSH terms
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs