Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462482
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Peri-Operative Testosterone Administration in Primary Hip Arthroscopy
Sponsor:
American Hip Institute
Organization:
American Hip Institute
Study Overview
Official Title:
Peri-Operative Testosterone Administration in Primary Hip Arthroscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is often observed that patients following hip surgery have a hard time with rehabilitation as patients commonly lose muscle mass and strength around the surgical site The goal of this study is to learn if giving patients testosterone around their hip surgery can prevent them from losing muscle mass as well as to see if it will improve their outcomes after surgery The main question this study aims to answer is Will perioperative testosterone administration increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo
Researchers will compare patients who were administered testosterone to standard of care no administration of testosterone to see if there is a difference in their recovery and outcomes
Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery Participants will have to answer questionnaires on how they are doing as well as will do other testing during this time
Researchers will compare patients who were administered testosterone to standard of care no administration of testosterone to see if there is a difference in their recovery and outcomes
Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery Participants will have to answer questionnaires on how they are doing as well as will do other testing during this time
Detailed Description:
The purpose of this double blinded randomized controlled trial is to determine if weekly intramuscular testosterone administration can prevent short-term catabolic loss of lean mass in patients undergoing hip arthroscopy and labral repair in addition to improving functional and patient-reported outcome scores It is hypothesized that perioperative testosterone administration will increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo This is the first study to our knowledge investigating the effects of perioperative testosterone administration on male patients undergoing hip arthroscopy and labral repair
Participants will be randomly assigned to receive testosterone or placebo treatment This will be performed using a simple 11 randomization and will be provided to the studys designated team member who is not associated with the study to be referred to as the pharmacist Except for the statistician performing the randomization and the pharmacist all individuals involved - including the investigators study team surgeon physical therapist and patient - will be blinded to the assigned treatment
Informed consent documentation will include an in-depth discussion of the possible but uncommon risks of testosterone including allergic reactions liver function test alterations breast tenderness hair growth or loss polycythemia and mood or mental changes These potential adverse events will be monitored during all study visits
The testosterone group will receive a 200mg dose of intramuscular testosterone cypionate also known as Nandrolone weekly for 8 weeks beginning 2 weeks prior to surgery The 200 mg per week regimen is being selected with the goal of being a dose sufficient to provide an anabolic stimulus and low enough to minimize potential adverse effects 10-13 Control participants in the placebo group will follow the same schedule of injections with an intramuscular dose of saline instead of testosterone All participants will follow a structured standard of care rehabilitation protocol within one week of surgery Common markers of endocrine function will be monitored for potential systemic side effects of testosterone using blood analysis of pituitary hormones including luteinizing hormone LH and follicle stimulating hormone FSH prostate-specific antigen PSA alanine aminotransferase ALT hematocrit hemoglobin and white blood cell at 2 weeks preoperatively the day of surgery and then 2 weeks 6 weeks 3 months and 2 years postoperatively
Participants will be randomly assigned to receive testosterone or placebo treatment This will be performed using a simple 11 randomization and will be provided to the studys designated team member who is not associated with the study to be referred to as the pharmacist Except for the statistician performing the randomization and the pharmacist all individuals involved - including the investigators study team surgeon physical therapist and patient - will be blinded to the assigned treatment
Informed consent documentation will include an in-depth discussion of the possible but uncommon risks of testosterone including allergic reactions liver function test alterations breast tenderness hair growth or loss polycythemia and mood or mental changes These potential adverse events will be monitored during all study visits
The testosterone group will receive a 200mg dose of intramuscular testosterone cypionate also known as Nandrolone weekly for 8 weeks beginning 2 weeks prior to surgery The 200 mg per week regimen is being selected with the goal of being a dose sufficient to provide an anabolic stimulus and low enough to minimize potential adverse effects 10-13 Control participants in the placebo group will follow the same schedule of injections with an intramuscular dose of saline instead of testosterone All participants will follow a structured standard of care rehabilitation protocol within one week of surgery Common markers of endocrine function will be monitored for potential systemic side effects of testosterone using blood analysis of pituitary hormones including luteinizing hormone LH and follicle stimulating hormone FSH prostate-specific antigen PSA alanine aminotransferase ALT hematocrit hemoglobin and white blood cell at 2 weeks preoperatively the day of surgery and then 2 weeks 6 weeks 3 months and 2 years postoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None