Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04345666
• Other study ID #: Orthopedicinstitutesf
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: August 2021
• Est. completion date: January 2023

Study information

• Verified date: February 2022
• Source: Orthopedic Institute, Sioux Falls, SD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Drug:
• Testosterone cypionate
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
• Placebos
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

Locations

Country	Name	City	State
United States	Orthopedic Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Orthopedic Institute, Sioux Falls, SD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Score	A validated joint specific patient-determined outcome score (low 0 - 100 high)	3 months after surgery
Primary	American Shoulder and Elbow Score	A validated joint specific patient-determined outcome score (low 0 - 100 high)	6 months after surgery
Primary	American Shoulder and Elbow Score	A validated joint specific patient-determined outcome score (low 0 - 100 high)	12 months after surgery
Primary	Simple Shoulder Test	A validated joint specific patient-determined outcome score (low 0 - 12 high)	3 months after surgery
Primary	Simple Shoulder Test	A validated joint specific patient-determined outcome score (low 0 - 12 high)	6 months after surgery
Primary	Simple Shoulder Test	A validated joint specific patient-determined outcome score (low 0 - 12 high)	12 months after surgery
Primary	Single Alpha-Numeric Assessment Evaluation	A validated general patient-determined outcome score (low 0 - 100 high)	3 months after surgery
Primary	Single Alpha-Numeric Assessment Evaluation	A validated general patient-determined outcome score (low 0 - 100 high)	6 months after surgery
Primary	Single Alpha-Numeric Assessment Evaluation	A validated general patient-determined outcome score (low 0 - 100 high)	12 months after surgery
Primary	Shoulder Activity Level	A validated shoulder-specific activity score (low 0 - 20 high)	3 months after surgery
Primary	Shoulder Activity Level	A validated shoulder-specific activity score (low 0 - 20 high)	6 months after surgery
Primary	Shoulder Activity Level	A validated shoulder-specific activity score (low 0 - 20 high)	12 months after surgery
Primary	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
Primary	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
Primary	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
Primary	Shoulder strength	Dynanometrically measured scaption and external rotation strength (Newtons)	3 months after surgery
Primary	Shoulder strength	Dynanometrically measured scaption and external rotation strength (Newtons)	6 months after surgery
Primary	Shoulder strength	Dynanometrically measured scaption and external rotation strength (Newtons)	12 months after surgery
Secondary	Magnetic resonance imaging shoulder	MRI	12 months after surgery