A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
Status: | Not yet recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 8/3/2018 |
Start Date: | May 1, 2019 |
End Date: | December 2023 |
Contact: | Christopher L Mendias, PhD, ATC |
Email: | MendiasC@hss.edu |
Phone: | 917-260-3783 |
A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
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.
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.
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
We found this trial at
1
site
535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Principal Investigator: Christopher L Mendias, PhD, ATC
Phone: 917-260-3783
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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