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Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone cypionate
Placebos
Sponsored by
Orthopedic Institute, Sioux Falls, SD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring arthroscopic rotator cuff repair, testosterone, accelerate recovery from surgery

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Testosterone group

Placebo group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Range of Motion
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Shoulder Range of Motion
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Shoulder Range of Motion
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)

Secondary Outcome Measures

Magnetic resonance imaging shoulder
MRI

Full Information

First Posted
April 9, 2020
Last Updated
February 28, 2022
Sponsor
Orthopedic Institute, Sioux Falls, SD
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1. Study Identification

Unique Protocol Identification Number
NCT04345666
Brief Title
Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
Official Title
A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain funding to complete the study
Study Start Date
August 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopedic Institute, Sioux Falls, SD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
arthroscopic rotator cuff repair, testosterone, accelerate recovery from surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blinded, placebo controlled model
Masking
ParticipantInvestigator
Masking Description
The patient and the primary investigator will be blinded to the treatment allocation. The study coordinator will be unblinded.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone group
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Testosterone cypionate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Sterile saline
Intervention Description
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
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
3 months after surgery
Title
American Shoulder and Elbow Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
6 months after surgery
Title
American Shoulder and Elbow Score
Description
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Time Frame
12 months after surgery
Title
Simple Shoulder Test
Description
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Time Frame
3 months after surgery
Title
Simple Shoulder Test
Description
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Time Frame
6 months after surgery
Title
Simple Shoulder Test
Description
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Time Frame
12 months after surgery
Title
Single Alpha-Numeric Assessment Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
3 months after surgery
Title
Single Alpha-Numeric Assessment Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
6 months after surgery
Title
Single Alpha-Numeric Assessment Evaluation
Description
A validated general patient-determined outcome score (low 0 - 100 high)
Time Frame
12 months after surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
3 months after surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
6 months after surgery
Title
Shoulder Activity Level
Description
A validated shoulder-specific activity score (low 0 - 20 high)
Time Frame
12 months after surgery
Title
Shoulder Range of Motion
Description
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Time Frame
3 months after surgery
Title
Shoulder Range of Motion
Description
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Time Frame
6 months after surgery
Title
Shoulder Range of Motion
Description
Goniometrically-measured (in degrees) Flexion, extension, abduction, external rotation, abducted external rotation, abducted internal rotation, internal rotation behind the back
Time Frame
12 months after surgery
Title
Shoulder strength
Description
Dynanometrically measured scaption and external rotation strength (Newtons)
Time Frame
3 months after surgery
Title
Shoulder strength
Description
Dynanometrically measured scaption and external rotation strength (Newtons)
Time Frame
6 months after surgery
Title
Shoulder strength
Description
Dynanometrically measured scaption and external rotation strength (Newtons)
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Magnetic resonance imaging shoulder
Description
MRI
Time Frame
12 months after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith M Baumgarten, MD
Organizational Affiliation
Orthopedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this point there is no plan to share individual participant data with researcher external to this study

Learn more about this trial

Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

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