Biceps TenodesisNCT05558579
Use of Postop Sling After Biceps Tenodesis
A study testing No sling use in people with Biceps Tenodesis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Biceps Tenodesis
- What is being tested?
- No sling use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 26 Sep 2024
- Phase
- Interventional
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo open or arthroscopic isolated BT for diagnoses including but not limited to biceps tendinitis or tenosynovitis, biceps tendon tears, partial-thickness rotator cuff tears, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear, biceps instability
- Patients with minimum 6-month follow-up
Who cannot join
- Patients who undergo any concomitant procedures necessitating ROM restrictions, including but not limited to rotator cuff repair, labral repair, SLAP lesion repair, or shoulder arthroplasty
- Patients with history of prior ipsilateral proximal biceps procedures
- Patients with history of conditions resulting in severe shoulder strength and ROM limitations (e.g. severe degenerative glenohumeral osteoarthritis, polymyalgia rheumatica, cervical radiculopathy, significant muscle paralysis, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis
The purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get better with medications or physical therapy. A biceps tenodesis involves cutting the biceps tendon and reconnecting it to the shoulder with sutures or metal screws. After surgery, most patients are required to wear a shoulder sling and limit certain arm motions to protect the healing tendon. A recent study found using a more flexible rehabilitation protocol for biceps tenodesis did not change outcomes (strength or range-of-motion) and allows patients to return to some regular activities earlier. This data suggests patients may not need to wear a sling after surgery. Therefore, this study aims to evaluate this.
This study will have two groups-one that continues to wear the sling, and one that does not. Patients will be randomly assigned to one of these groups. At each follow-up visit after surgery, shoulder strength and range-of-motion will be measured and several surveys about shoulder function will be completed. These surveys will provide information to compare between both groups. If assigned to the group that wears the sling, patients will record how often they are wearing the sling in a paper diary/log. Additionally, at the 6-month follow-up, an ultrasound will be obtained to make sure the tendon is healing properly regardless of which group patients are assigned to. Finally, medical history will be collected to identify protective and risk factors for any differences that might be found.
- Conditions
- Biceps Tenodesis
- Being tested
- No sling use
- Keywords
- shoulder rehabilitation, shoulder sling, biceps disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No sling useOther
Patients will not use standard of care sling
| Study group | Role | What they receive |
|---|---|---|
| Patients Using Sling | No intervention | Patients will continue using shoulder sling per standard of care |
| Patients Without Sling | Experimental | Patients will not use shoulder sling postoperatively. Receives: Other: No sling use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Complications As Measured by Medical Records
Measured: Up to 2 years
Degrees of Range-of-Motion As Measured by Physical Exam
Measured: Up to 30 minutes
Strength as Measured by Physical Exam
Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance
Measured: Up to 30 minutes
Secondary outcomes (7)
Pain as Measured by the Visual Analog Scale
VAS is a 10-point scale with 0 being no pain and 10 being worst possible pain
Measured: Up to 5 minutes
Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES)
ASES is a 17-item survey that has a score from 0-100
Measured: Up to 15 minutes
Shoulder Function as Measured by the Simple Shoulder Test (SST)
SST is a 12-item survey that has a score up to 12 points
Measured: Up to 15 minutes
Shoulder Function as Measured by Constant Murley Score (CMS)
CMS is scored up to 100 points maximum
Measured: Up to 15 minutes
Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index
WORC is a 21-item survey scored on a scale from 2,100 to 0
Measured: Up to 15 minutes
Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE)
SANE is a 1-item survey that has a score from 0-100
Measured: Up to 5 minutes
Percent of Patients Satisfied as Measured by Patient Survey
Yes/no survey asking about satisfaction with care
Measured: Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start23 Mar 2023
- Primary completion26 Sep 2024 (estimated)
- Study completion26 Sep 2024 (estimated)
Why it stopped: Unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biceps TenodesisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Karns, MD., University Hospitals Cleveland Medical Center
- Investigators
- Michael Karns, MD, Principal investigator, University HospitalsKallie Chen, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558579
- Sponsor's protocol ID
- STUDY20220856
- Status last verified
- Apr 2024
- First submitted
- 23 Sep 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis
- ClinicalTrials.gov ID
- NCT05558579
- Acronym / sponsor ID
- STUDY20220856
- Conditions
- Biceps Tenodesis
- Keywords
- shoulder rehabilitation, shoulder sling, biceps disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 26 Sep 2024 (estimated)
- Study completion
- 26 Sep 2024 (estimated)
- First posted
- 28 Sep 2022 (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 purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get better with medications or physical therapy. A biceps tenodesis involves cutting the biceps tendon and reconnecting it to the shoulder with sutures or metal screws. After surgery, most patients are required to wear a shoulder sling and limit certain arm motions to protect the healing tendon. A recent study found using a more flexible rehabilitation protocol for biceps tenodesis did not change outcomes (strength or range-of-motion) and allows patients to return to some regular activities earlier. This data suggests patients may not need to wear a sling after surgery. Therefore, this study aims to evaluate this.
This study will have two groups-one that continues to wear the sling, and one that does not. Patients will be randomly assigned to one of these groups. At each follow-up visit after surgery, shoulder strength and range-of-motion will be measured and several surveys about shoulder function will be completed. These surveys will provide information to compare between both groups. If assigned to the group that wears the sling, patients will record how often they are wearing the sling in a paper diary/log. Additionally, at the 6-month follow-up, an ultrasound will be obtained to make sure the tendon is healing properly regardless of which group patients are assigned to. Finally, medical history will be collected to identify protective and risk factors for any differences that might be found.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Using Sling | No intervention | –Patients will continue using shoulder sling per standard of care |
| Patients Without Sling | Experimental | Other: No sling usePatients will not use shoulder sling postoperatively. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo open or arthroscopic isolated BT for diagnoses including but not limited to biceps tendinitis or tenosynovitis, biceps tendon tears, partial-thickness rotator cuff tears, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear, biceps instability
- Patients with minimum 6-month follow-up
Key exclusion criteria (3 listed)
- Patients who undergo any concomitant procedures necessitating ROM restrictions, including but not limited to rotator cuff repair, labral repair, SLAP lesion repair, or shoulder arthroplasty
- Patients with history of prior ipsilateral proximal biceps procedures
- Patients with history of conditions resulting in severe shoulder strength and ROM limitations (e.g. severe degenerative glenohumeral osteoarthritis, polymyalgia rheumatica, cervical radiculopathy, significant muscle paralysis, etc.)
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 |
|---|---|---|
| No sling usePatients will not use standard of care sling | Other | Patients Without Sling |
Primary outcome
Percent of Complications As Measured by Medical Records
Time frame: Up to 2 years
Degrees of Range-of-Motion As Measured by Physical Exam
Time frame: Up to 30 minutes
Strength as Measured by Physical Exam
Time frame: Up to 30 minutes
Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance
7 secondary outcomes
Pain as Measured by the Visual Analog Scale
Time frame: Up to 5 minutes
Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES)
Time frame: Up to 15 minutes
Shoulder Function as Measured by the Simple Shoulder Test (SST)
Time frame: Up to 15 minutes
Shoulder Function as Measured by Constant Murley Score (CMS)
Time frame: Up to 15 minutes
Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index
Time frame: Up to 15 minutes
Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE)
Time frame: Up to 5 minutes
Percent of Patients Satisfied as Measured by Patient Survey
Time frame: Up to 5 minutes
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 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Biceps Tenodesis
Recruiting
Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)
Rotator Cuff Injury
Recruiting
Biceps Tenodesis With 360 Suture Anchor Versus Self Locking Tenodesis In the Absence of Rotator Cuff Tears
SLAP Lesion
Active, not recruiting
Patient Outcomes Collection: How Can we do Better?
Shoulder Pain
Not yet recruitingObservational study
Impact of Rotator Cuff Repair on Rehabilitation Outcome
Rotator Cuff Repairs
Not yet recruiting
Biceps Tenodesis Alone Versus Biceps Tenodesis and Labrum Repair in Superior Labrum Anteroposterior ( SLAP) From Type II to Type IV
SLAP Lesion
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.
Michael Karns, MD principal investigator
University Hospitals
Kallie Chen, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No sling use in people with Biceps Tenodesis, run by University Hospitals Cleveland Medical Center 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 3 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 24 Apr 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Percent of Complications As Measured by Medical Records (time frame: Up to 2 years). The study lists 3 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 24 Apr 2024.