Health TrialsbyHealthPanel

Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty

ConditionOsteoarthritis, Hip
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorAmerican Hip Institute

About this trial

It is often observed that patients following total hip replacement 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male patients over the age of 18 with a diagnosis of osteoarthritis or dysplasia that are undergoing total hip replacement will be recruited to the study and screened for eligibility. Inclusion criteria include clinical diagnosis of osteoarthritis or dysplasia, age 18 and older, and hypogonadism, defined as a testosterone level <300ng/dL or clinical signs of hypogonadism including reduced muscle mass and strength, decreased libido, erectile dysfunction, loss of body hair, low bone mineral density, infertility, gynecomastia, or incomplete or delayed sexual development.

Disqualifiers

Major exclusion criteria include previous arthroplasty of the affected hip, previous spine surgery, 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nandrolone decanoate

    Drug

    Nandrolone will be administered to the testosterone group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.

  • Saline

    Drug

    Saline will be administered to the saline group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Testosterone armExperimental treatment 1 intervention
Group B: Saline ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

modified Harris Hip Score

Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

Time frame
2 years

Secondary outcomes

1

HOS-SSS

Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

Time frame
2 years
2

iHOT-12

Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

Time frame
2 years
3

Total lean body mass

Measuring total lean body mass via Lunar IDXA

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American Hip Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: