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NCT05558579 | Recruiting | Biceps Tenodesis


Use of Postop Sling After Biceps Tenodesis
Sponsor:

University Hospitals Cleveland Medical Center

Information provided by (Responsible Party):

Michael Karns, MD.

Brief 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 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.

Condition or disease

Biceps Tenodesis

Intervention/treatment

No sling use

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis
Actual Study Start Date : March 23, 2023
Estimated Primary Completion Date : September 26, 2024
Estimated Study Completion Date : September 26, 2024
Arm Intervention/treatment

No Intervention: Patients Using Sling

Patients will continue using shoulder sling per standard of care

Experimental: Patients Without Sling

Patients will not use shoulder sling postoperatively.

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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.)

Use of Postop Sling After Biceps Tenodesis

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Use of Postop Sling After Biceps Tenodesis

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Locations


Recruiting

United States, Ohio

University Hospitals

Cleveland, Ohio, United States, 44106

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