Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair

Orthopedic Institute, Sioux Falls, SD

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Rotator Cuff Tears

Treatments: Drug: Testosterone cypionate; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04345666

Orthopedicinstitutesf

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 45 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Testosterone group

Experimental group

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).

Treatment:

Drug: Testosterone cypionate

Placebo group

Placebo Comparator group

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).

Treatment:

Drug: Placebos