Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

NCT04345666 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Orthopedicinstitutesf
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if treating patients undergoing arthroscopic rotator cuff repair with testosterone will allow patients to accelerate their recovery time after surgery.

Conditions

Rotator Cuff Tears

Keywords

arthroscopic rotator cuff repair; testosterone; accelerate recovery from surgery

Outcome Measures

Primary Outcomes (18)

• American Shoulder and Elbow Score

  A validated joint specific patient-determined outcome score (low 0 - 100 high)

  3 months after surgery

• American Shoulder and Elbow Score

  A validated joint specific patient-determined outcome score (low 0 - 100 high)

  6 months after surgery

• American Shoulder and Elbow Score

  A validated joint specific patient-determined outcome score (low 0 - 100 high)

  12 months after surgery

• Simple Shoulder Test

  A validated joint specific patient-determined outcome score (low 0 - 12 high)

  3 months after surgery

• Simple Shoulder Test

  A validated joint specific patient-determined outcome score (low 0 - 12 high)

  6 months after surgery

• Simple Shoulder Test

  A validated joint specific patient-determined outcome score (low 0 - 12 high)

  12 months after surgery

• Single Alpha-Numeric Assessment Evaluation

  A validated general patient-determined outcome score (low 0 - 100 high)

  3 months after surgery

• Single Alpha-Numeric Assessment Evaluation

  A validated general patient-determined outcome score (low 0 - 100 high)

  6 months after surgery

• Single Alpha-Numeric Assessment Evaluation

  A validated general patient-determined outcome score (low 0 - 100 high)

  12 months after surgery

• Shoulder Activity Level

  A validated shoulder-specific activity score (low 0 - 20 high)

  3 months after surgery

• Shoulder Activity Level

  A validated shoulder-specific activity score (low 0 - 20 high)

  6 months after surgery

• Shoulder Activity Level

  A validated shoulder-specific activity score (low 0 - 20 high)

  12 months after surgery

• Shoulder Range of Motion

  Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back

  3 months after surgery

• Shoulder Range of Motion

  Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back

  6 months after surgery

• Shoulder Range of Motion

  Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back

  12 months after surgery

• Shoulder strength

  Dynanometrically measured scaption and external rotation strength (Newtons)

  3 months after surgery

• Shoulder strength

  Dynanometrically measured scaption and external rotation strength (Newtons)

  6 months after surgery

• Shoulder strength

  Dynanometrically measured scaption and external rotation strength (Newtons)

  12 months after surgery

Secondary Outcomes (1)

• Magnetic resonance imaging shoulder

  12 months after surgery

Study Arms (2)

Testosterone group

EXPERIMENTAL

20 patients will receive a 200 mg testosterone cyprionate intramuscular injection weekly with the first dose started two weeks prior to surgery and the last dose injected at 6 weeks after surgery (9 doses).

Drug: Testosterone cypionate

Placebo group

PLACEBO COMPARATOR

20 patients will receive a sterile saline intramuscular injection weekly with the first dose started two weeks prior to surgery and the last dose injected at 6 weeks after surgery (9 doses).

Drug: Placebos

Interventions

Testosterone cypionate DRUG

The intervention of this study is to treat patients to either 1) testosterone cypionate or 2) placebo (sterile saline) to determine if there is a difference in recovery times after arthroscopic rotator cuff repair

Testosterone group

Placebos DRUG

The intervention of this study is to treat patients to either 1) testosterone cypionate or 2) placebo (sterile saline) to determine if there is a difference in recovery times after arthroscopic rotator cuff repair

Also known as: Sterile saline

Placebo group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males
• arthroscopic rotator cuff repair is an indicated treatment

You may not qualify if:

• female patients
• irreparable rotator cuff tears
• tears requiring margin convergence repair
• atrophy of the rotator cuff greater than stage II as determined by the modified Goutallier staging system
• revision rotator cuff repair
• inflammatory arthritis
• adhesive capsulitis
• significant cervical pain or radiculopathy
• history of prostate cancer
• history of benign prostatic hypertrophy
• history of heart failure
• history of obstructive sleep apnea
• history of polycythemia
• history of venous thromboembolism or inherited thrombophilia

Sponsors & Collaborators

• Orthopedic Institute, Sioux Falls, SD: lead

Study Sites (1)

Orthopedic Institute

Sioux Falls, South Dakota, 57117, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Keith M Baumgarten, MD

  Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient and the primary investigator will be blinded to the treatment allocation. The study coordinator will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon - Physician Scientis

Model Details: Randomized, double-blinded, placebo controlled model

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)