The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.
Adolescent
Adult
Anterior Cruciate Ligament Injuries
/ surgery
Anterior Cruciate Ligament Reconstruction
Human Growth Hormone
/ therapeutic use
Humans
Knee Joint
Male
Muscle Strength
Muscle Weakness
/ drug therapy
Pilot Projects
Quadriceps Muscle
/ physiology
Recombinant Proteins
/ therapeutic use
Young Adult
anterior cruciate ligament
human growth hormone
muscle atrophy
orthobiologics
somatropin
Journal
The American journal of sports medicine
ISSN: 1552-3365
Titre abrégé: Am J Sports Med
Pays: United States
ID NLM: 7609541
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
pubmed:
27
5
2020
medline:
11
11
2020
entrez:
27
5
2020
Statut:
ppublish
Résumé
Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR. Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR. Randomized controlled trial; Level of evidence, 2. A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period ( HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted. NCT02420353 ( ClinicalTrials.gov identifier).
Sections du résumé
BACKGROUND
Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR.
HYPOTHESIS
Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 2.
METHODS
A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at
RESULTS
HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period (
CONCLUSION
HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted.
REGISTRATION
NCT02420353 ( ClinicalTrials.gov identifier).
Identifiants
pubmed: 32452208
doi: 10.1177/0363546520920591
pmc: PMC7351248
mid: NIHMS1598109
doi:
Substances chimiques
Recombinant Proteins
0
Human Growth Hormone
12629-01-5
Banques de données
ClinicalTrials.gov
['NCT02420353']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1916-1928Subventions
Organisme : NIAMS NIH HHS
ID : F31 AR065931
Pays : United States
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