Peri-Operative Testosterone Administration in Primary Hip Arthroscopy

Femoro Acetabular Impingement Clinical Trial

Official title:

Peri-Operative Testosterone Administration in Primary Hip Arthroscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462482
• Other study ID #: AHI-004
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: American Hip Institute
• Contact: Alexandra Mantice
• Phone: 8338724477
• Email: alexandra.mantice[@]americanhipinstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 1:1 randomization and will be provided to the study's 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Male patients over the age of 18 with a diagnosis of femoroacetabular impingement (FAI) with labral tear will be recruited to the study and screened for eligibility. Inclusion criteria include clinical diagnosis of FAI, age 18 and older, and hypogonadism, defined as a testosterone level <300ng/dL.

Exclusion Criteria:

• . Major exclusion criteria include previous surgery to the affected hip or spine, LCEA < 18, a past medical history significant for allergy to testosterone, prostate cancer, PSA > 4 ng/ml, breast cancer, polycythemia, diabetes mellitus with a HbA1c > 7, BMI < 18 or > 40, and preoperative motion or strength limitations that will affect postoperative rehabilitation.

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro Acetabular Impingement

Intervention

Drug:
• Nandrolone Decanoate
Nandrolone will be administered to the testosterone group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.
• Saline
Saline will be administered to the saline group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
American Hip Institute

References & Publications (14)

Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x. — View Citation

Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30. — View Citation

Basaria S, Wahlstrom JT, Dobs AS. Clinical review 138: Anabolic-androgenic steroid therapy in the treatment of chronic diseases. J Clin Endocrinol Metab. 2001 Nov;86(11):5108-17. doi: 10.1210/jcem.86.11.7983. — View Citation

Beck EC, Nwachukwu BU, Krivicich LM, Malloy P, Suppauksorn S, Jan K, Nho SJ. Preoperative Hip Extension Strength Is an Independent Predictor of Achieving Clinically Significant Outcomes After Hip Arthroscopy for Femoroacetabular Impingement Syndrome. Sports Health. 2020 Jul/Aug;12(4):361-372. doi: 10.1177/1941738120910134. Epub 2020 May 11. — View Citation

Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A, Casaburi R. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med. 1996 Jul 4;335(1):1-7. doi: 10.1056/NEJM199607043350101. — View Citation

Bhasin S, Storer TW, Javanbakht M, Berman N, Yarasheski KE, Phillips J, Dike M, Sinha-Hikim I, Shen R, Hays RD, Beall G. Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. JAMA. 2000 Feb 9;283(6):763-70. doi: 10.1001/jama.283.6.763. — View Citation

Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172. — View Citation

Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26. — View Citation

Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x. — View Citation

Rothney MP, Martin FP, Xia Y, Beaumont M, Davis C, Ergun D, Fay L, Ginty F, Kochhar S, Wacker W, Rezzi S. Precision of GE Lunar iDXA for the measurement of total and regional body composition in nonobese adults. J Clin Densitom. 2012 Oct-Dec;15(4):399-404. doi: 10.1016/j.jocd.2012.02.009. Epub 2012 Apr 26. — View Citation

Sattler FR, Castaneda-Sceppa C, Binder EF, Schroeder ET, Wang Y, Bhasin S, Kawakubo M, Stewart Y, Yarasheski KE, Ulloor J, Colletti P, Roubenoff R, Azen SP. Testosterone and growth hormone improve body composition and muscle performance in older men. J Clin Endocrinol Metab. 2009 Jun;94(6):1991-2001. doi: 10.1210/jc.2008-2338. Epub 2009 Mar 17. — View Citation

Serra C, Bhasin S, Tangherlini F, Barton ER, Ganno M, Zhang A, Shansky J, Vandenburgh HH, Travison TG, Jasuja R, Morris C. The role of GH and IGF-I in mediating anabolic effects of testosterone on androgen-responsive muscle. Endocrinology. 2011 Jan;152(1):193-206. doi: 10.1210/en.2010-0802. Epub 2010 Nov 17. — View Citation

White JP, Baltgalvis KA, Sato S, Wilson LB, Carson JA. Effect of nandrolone decanoate administration on recovery from bupivacaine-induced muscle injury. J Appl Physiol (1985). 2009 Nov;107(5):1420-30. doi: 10.1152/japplphysiol.00668.2009. Epub 2009 Sep 10. — View Citation

Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Harris Hip Score	Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome	2 years
Secondary	Total lean body mass	Measuring total lean body mass via Lunar IDXA	2 years
Secondary	Nonarthritic Hip Score	Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome	2 years
Secondary	HOS-SSS	Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome	2 years
Secondary	iHOT-12	Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome	2 years
Secondary	Age	Demographic information	Before surgery
Secondary	Body mass index	Demographic information	Before surgery
Secondary	Sex	Demographic information	Before surgery