Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

February 28, 2022 updated by: Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD

A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Specific Aim I:

To determine if testosterone treatment would provide superior patient-determined quality-of-life and activity scores in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery.

Specific Aim II:

To determine if testosterone treatment would allow for greater postoperative strength improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery.

Specific Aim III:

To determine if testosterone treatment would allow for greater postoperative range of motion improvements in patients undergoing arthroscopic rotator cuff repair compared to a control group at 3 months after surgery.

Specific Aim IV:

To determine if the potentially higher activity levels allowed by the testosterone treatment would affect the success of rotator cuff healing as determined by magnetic resonance imaging at one year after arthroscopic rotator cuff repair.

The hypothesis of this study was that testosterone treatment of patients undergoing arthroscopic rotator cuff repair would allow patients to achieve 1) better quality-of-life and higher activity levels as determined by patient-determined outcome scores, 2) greater improvements in strength, and 3) greater improvements in range of motion at three months after surgery as compared to the control group. In addition, the authors hypothesize that there would be equivalent healing rates at one year after rotator cuff repair as determined by magnetic resonance imaging between the testosterone group and the control group.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Orthopedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males
  • arthroscopic rotator cuff repair is an indicated treatment

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testosterone group
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).
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
Placebo Comparator: Placebo group
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).
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
Other Names:
  • Sterile saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Score
Time Frame: 3 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
3 months after surgery
American Shoulder and Elbow Score
Time Frame: 6 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
6 months after surgery
American Shoulder and Elbow Score
Time Frame: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
12 months after surgery
Simple Shoulder Test
Time Frame: 3 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
3 months after surgery
Simple Shoulder Test
Time Frame: 6 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
6 months after surgery
Simple Shoulder Test
Time Frame: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
12 months after surgery
Single Alpha-Numeric Assessment Evaluation
Time Frame: 3 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
3 months after surgery
Single Alpha-Numeric Assessment Evaluation
Time Frame: 6 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
6 months after surgery
Single Alpha-Numeric Assessment Evaluation
Time Frame: 12 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
12 months after surgery
Shoulder Activity Level
Time Frame: 3 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
3 months after surgery
Shoulder Activity Level
Time Frame: 6 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
6 months after surgery
Shoulder Activity Level
Time Frame: 12 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
12 months after surgery
Shoulder Range of Motion
Time Frame: 3 months after surgery
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
Time Frame: 6 months after surgery
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
Time Frame: 12 months after surgery
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
Time Frame: 3 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
3 months after surgery
Shoulder strength
Time Frame: 6 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
6 months after surgery
Shoulder strength
Time Frame: 12 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic resonance imaging shoulder
Time Frame: 12 months after surgery
MRI
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Keith M Baumgarten, MD, Orthopedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

At this point there is no plan to share individual participant data with researcher external to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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