Clinical trial NCT04345666: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Rotator Cuff Tears
Keywords: arthroscopic rotator cuff repair
testosterone
accelerate recovery from surgery
Lead sponsor: Orthopedic Institute, Sioux Falls, SD
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 0
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded, placebo controlled model
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: American Shoulder and Elbow Score
timeFrame: 3 months after surgery
measure: American Shoulder and Elbow Score
timeFrame: 6 months after surgery
measure: American Shoulder and Elbow Score
timeFrame: 12 months after surgery
measure: Simple Shoulder Test
timeFrame: 3 months after surgery
measure: Simple Shoulder Test
timeFrame: 6 months after surgery
measure: Simple Shoulder Test
timeFrame: 12 months after surgery
measure: Single Alpha-Numeric Assessment Evaluation
timeFrame: 3 months after surgery
measure: Single Alpha-Numeric Assessment Evaluation
timeFrame: 6 months after surgery
measure: Single Alpha-Numeric Assessment Evaluation
timeFrame: 12 months after surgery
measure: Shoulder Activity Level
timeFrame: 3 months after surgery
measure: Shoulder Activity Level
timeFrame: 6 months after surgery
measure: Shoulder Activity Level
timeFrame: 12 months after surgery
measure: Shoulder Range of Motion
timeFrame: 3 months after surgery
measure: Shoulder Range of Motion
timeFrame: 6 months after surgery
measure: Shoulder Range of Motion
timeFrame: 12 months after surgery
measure: Shoulder strength
timeFrame: 3 months after surgery
measure: Shoulder strength
timeFrame: 6 months after surgery
measure: Shoulder strength
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Magnetic resonance imaging shoulder
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Orthopedic Institute
state: South Dakota
Study officials:
affiliation: Orthopedic Institute
name: Keith M Baumgarten, MD
role: PRINCIPAL_INVESTIGATOR
References: