- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345666
Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117
- Orthopedic Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Testosterone group
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).
|
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
|
Placebo Comparator: Placebo group
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).
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American Shoulder and Elbow Score
Time Frame: 3 months after surgery
|
A validated joint specific patient-determined outcome score (low 0 - 100 high)
|
3 months after surgery
|
American Shoulder and Elbow Score
Time Frame: 6 months after surgery
|
A validated joint specific patient-determined outcome score (low 0 - 100 high)
|
6 months after surgery
|
American Shoulder and Elbow Score
Time Frame: 12 months after surgery
|
A validated joint specific patient-determined outcome score (low 0 - 100 high)
|
12 months after surgery
|
Simple Shoulder Test
Time Frame: 3 months after surgery
|
A validated joint specific patient-determined outcome score (low 0 - 12 high)
|
3 months after surgery
|
Simple Shoulder Test
Time Frame: 6 months after surgery
|
A validated joint specific patient-determined outcome score (low 0 - 12 high)
|
6 months after surgery
|
Simple Shoulder Test
Time Frame: 12 months after surgery
|
A validated joint specific patient-determined outcome score (low 0 - 12 high)
|
12 months after surgery
|
Single Alpha-Numeric Assessment Evaluation
Time Frame: 3 months after surgery
|
A validated general patient-determined outcome score (low 0 - 100 high)
|
3 months after surgery
|
Single Alpha-Numeric Assessment Evaluation
Time Frame: 6 months after surgery
|
A validated general patient-determined outcome score (low 0 - 100 high)
|
6 months after surgery
|
Single Alpha-Numeric Assessment Evaluation
Time Frame: 12 months after surgery
|
A validated general patient-determined outcome score (low 0 - 100 high)
|
12 months after surgery
|
Shoulder Activity Level
Time Frame: 3 months after surgery
|
A validated shoulder-specific activity score (low 0 - 20 high)
|
3 months after surgery
|
Shoulder Activity Level
Time Frame: 6 months after surgery
|
A validated shoulder-specific activity score (low 0 - 20 high)
|
6 months after surgery
|
Shoulder Activity Level
Time Frame: 12 months after surgery
|
A validated shoulder-specific activity score (low 0 - 20 high)
|
12 months after surgery
|
Shoulder Range of Motion
Time Frame: 3 months after surgery
|
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
Time Frame: 6 months after surgery
|
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
Time Frame: 12 months after surgery
|
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
Time Frame: 3 months after surgery
|
Dynanometrically measured scaption and external rotation strength (Newtons)
|
3 months after surgery
|
Shoulder strength
Time Frame: 6 months after surgery
|
Dynanometrically measured scaption and external rotation strength (Newtons)
|
6 months after surgery
|
Shoulder strength
Time Frame: 12 months after surgery
|
Dynanometrically measured scaption and external rotation strength (Newtons)
|
12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnetic resonance imaging shoulder
Time Frame: 12 months after surgery
|
MRI
|
12 months after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Keith M Baumgarten, MD, Orthopedic Institute
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Rotator Cuff Injuries
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- Orthopedicinstitutesf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tears
-
Xiros LtdNot yet recruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the Shoulder
-
Gazi UniversityRecruitingMassive Irreparable Rotator Cuff TearsTurkey
-
The Cleveland ClinicRecruitingRotator Cuff Tears | Rotator Cuff RepairsUnited States
-
Nova Scotia Health AuthorityRecruiting
-
National Taiwan University HospitalRecruiting
-
Istituto Ortopedico RizzoliRecruiting
-
La Tour HospitalRecruiting
-
Panam ClinicUniversity of ManitobaNot yet recruitingRotator Cuff Tears
-
RenJi HospitalNot yet recruiting
-
University Hospitals, LeicesterRecruitingRotator Cuff TearsUnited Kingdom
Clinical Trials on Testosterone cypionate
-
Hospital Sirio-LibanesHospital Moinhos de VentoCompleted
-
Men's Health BostonCompletedHypogonadism, Male | Testosterone DeficiencyUnited States
-
University of British ColumbiaVancouver Coastal Health Research InstituteCompleted
-
Massachusetts General HospitalWithdrawnThe Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia NervosaBone MetabolismUnited States
-
Yale UniversityDendreonRecruitingMetastatic Castration-resistant Prostate CancerUnited States
-
University of MiamiAcerus Pharmaceuticals CorporationCompletedHypogonadism, MaleUnited States
-
M.D. Anderson Cancer CenterCompletedAdvanced CancerUnited States
-
Brigham and Women's HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not yet recruitingMenopause | Stress Urinary Incontinence
-
Latin American Cooperative Oncology GroupBayerActive, not recruiting
-
Dana-Farber Cancer InstituteNational Institute on Aging (NIA)RecruitingProstate CancerUnited States