Rotator Cuff TearsPhase 2/3NCT04345666
Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
A Phase 2/3 study testing Testosterone cypionate in people with Rotator Cuff Tears, run by Orthopedic Institute, Sioux Falls, SD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Testosterone cypionate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2021to Jan 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males
- arthroscopic rotator cuff repair is an indicated treatment
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Institute
Sioux Falls, South Dakota, 57117
About this study
Official title: A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Testosterone cypionate, Placebos
- Keywords
- arthroscopic rotator cuff repair, testosterone, accelerate recovery from surgery
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone cypionateDrug
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
PlacebosDrug
Also called Sterile saline
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Testosterone cypionate |
| 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). Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: 3 months after surgery
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: 6 months after surgery
American Shoulder and Elbow Score
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Measured: 12 months after surgery
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Measured: 3 months after surgery
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Measured: 6 months after surgery
Simple Shoulder Test
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Measured: 12 months after surgery
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 3 months after surgery
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 6 months after surgery
Single Alpha-Numeric Assessment Evaluation
A validated general patient-determined outcome score (low 0 - 100 high)
Measured: 12 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: 3 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: 6 months after surgery
Shoulder Activity Level
A validated shoulder-specific activity score (low 0 - 20 high)
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after surgery
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Measured: 3 months after surgery
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Measured: 6 months after surgery
Shoulder strength
Dynanometrically measured scaption and external rotation strength (Newtons)
Measured: 12 months after surgery
Secondary outcomes (1)
Magnetic resonance imaging shoulder
MRI
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study startAug 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Unable to obtain funding to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo controlled model
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Institute, Sioux Falls, SD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD
- Investigators
- Keith M Baumgarten, MD, Principal investigator, Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345666
- Sponsor's protocol ID
- Orthopedicinstitutesf
- Status last verified
- Feb 2022
- First submitted
- 9 Apr 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this point there is no plan to share individual participant data with researcher external to this study
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded Controlled Trial to Determine if Testosterone Can Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT04345666
- Acronym / sponsor ID
- Orthopedicinstitutesf
- Conditions
- Rotator Cuff Tears
- Keywords
- arthroscopic rotator cuff repair, testosterone, accelerate recovery from surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding to complete the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Orthopedic Institute, Sioux Falls, SDUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo controlled model
| Arm | Type | Receives |
|---|---|---|
| Testosterone group | Experimental | Drug: Testosterone cypionate20 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). |
| Placebo group | Placebo comparator | Drug: Placebos20 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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males
- arthroscopic rotator cuff repair is an indicated treatment
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone cypionateThe 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 | Drug | Testosterone group |
| PlacebosAlso: Sterile salineThe 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 | Drug | Placebo group |
Primary outcome
American Shoulder and Elbow Score
Time frame: 3 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Score
Time frame: 6 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
American Shoulder and Elbow Score
Time frame: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 100 high)
Simple Shoulder Test
Time frame: 3 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Simple Shoulder Test
Time frame: 6 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Simple Shoulder Test
Time frame: 12 months after surgery
A validated joint specific patient-determined outcome score (low 0 - 12 high)
Single Alpha-Numeric Assessment Evaluation
Time frame: 3 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
Single Alpha-Numeric Assessment Evaluation
Time frame: 6 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
Single Alpha-Numeric Assessment Evaluation
Time frame: 12 months after surgery
A validated general patient-determined outcome score (low 0 - 100 high)
Shoulder Activity Level
Time frame: 3 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
Time frame: 6 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
Shoulder Activity Level
Time frame: 12 months after surgery
A validated shoulder-specific activity score (low 0 - 20 high)
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
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
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
Shoulder strength
Time frame: 3 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
Shoulder strength
Time frame: 6 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
Shoulder strength
Time frame: 12 months after surgery
Dynanometrically measured scaption and external rotation strength (Newtons)
1 secondary outcome
Magnetic resonance imaging shoulder
Time frame: 12 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No. At this point there is no plan to share individual participant data with researcher external to this study
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Voll Non-Degradable Shoulder Spacer FIH Study
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Active, not recruitingPhase 2
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SMR Stemless Reverse vs SMR Reverse Shoulder System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith M Baumgarten, MD principal investigator
Orthopedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Testosterone cypionate in people with Rotator Cuff Tears, run by Orthopedic Institute, Sioux Falls, SD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Score (time frame: 3 months after surgery). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.