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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone group | Experimental | 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). |
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| Placebo group | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone cypionate | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 3 months after surgery |
| American Shoulder and Elbow Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 6 months after surgery |
| American Shoulder and Elbow Score | A validated joint specific patient-determined outcome score (low 0 - 100 high) | 12 months after surgery |
| Simple Shoulder Test | A validated joint specific patient-determined outcome score (low 0 - 12 high) | 3 months after surgery |
| Simple Shoulder Test | A validated joint specific patient-determined outcome score (low 0 - 12 high) | 6 months after surgery |
| Simple Shoulder Test | A validated joint specific patient-determined outcome score (low 0 - 12 high) | 12 months after surgery |
| Single Alpha-Numeric Assessment Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 3 months after surgery |
| Single Alpha-Numeric Assessment Evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic resonance imaging shoulder | MRI | 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith M Baumgarten, MD | Orthopedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Institute | Sioux Falls | South Dakota | 57117 | United States |
At this point there is no plan to share individual participant data with researcher external to this study
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| C016131 | testosterone 17 beta-cypionate |
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Randomized, double-blinded, placebo controlled model
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The patient and the primary investigator will be blinded to the treatment allocation. The study coordinator will be unblinded.
| Placebos | Drug | 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 |
|
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A validated general patient-determined outcome score (low 0 - 100 high)
| 6 months after surgery |
| Single Alpha-Numeric Assessment Evaluation | A validated general patient-determined outcome score (low 0 - 100 high) | 12 months after surgery |
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 3 months after surgery |
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 6 months after surgery |
| Shoulder Activity Level | A validated shoulder-specific activity score (low 0 - 20 high) | 12 months after surgery |
| 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 |
| 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 |
| 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 |
| Shoulder strength | Dynanometrically measured scaption and external rotation strength (Newtons) | 3 months after surgery |
| Shoulder strength | Dynanometrically measured scaption and external rotation strength (Newtons) | 6 months after surgery |
| Shoulder strength | Dynanometrically measured scaption and external rotation strength (Newtons) | 12 months after surgery |