Use of Postop Sling After Biceps Tenodesis

  • STATUS
    Recruiting
  • End date
    Sep 26, 2024
  • participants needed
    150
  • sponsor
    University Hospitals Cleveland Medical Center
Updated on 11 April 2023

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.

Details
Condition Biceps Tenodesis
Treatment No sling use
Clinical Study IdentifierNCT05558579
SponsorUniversity Hospitals Cleveland Medical Center
Last Modified on11 April 2023

Eligibility

Yes No Not Sure

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.)
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