Biceps Tenodesis
Conditions
Keywords
shoulder rehabilitation, shoulder sling, biceps disorders
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.
Interventions
OTHERNo sling use
Patients will not use standard of care sling
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Complications As Measured by Medical Records | Up to 2 years | — |
| Degrees of Range-of-Motion As Measured by Physical Exam | Up to 30 minutes | — |
| Strength as Measured by Physical Exam | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Function as Measured by Constant Murley Score (CMS) | Up to 15 minutes | CMS is scored up to 100 points maximum |
| Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index | Up to 15 minutes | WORC is a 21-item survey scored on a scale from 2,100 to 0 |
| Pain as Measured by the Visual Analog Scale | Up to 5 minutes | VAS is a 10-point scale with 0 being no pain and 10 being worst possible pain |
| Percent of Patients Satisfied as Measured by Patient Survey | Up to 5 minutes | Yes/no survey asking about satisfaction with care |
| Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE) | Up to 5 minutes | SANE is a 1-item survey that has a score from 0-100 |
| Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES) | Up to 15 minutes | ASES is a 17-item survey that has a score from 0-100 |
| Shoulder Function as Measured by the Simple Shoulder Test (SST) | Up to 15 minutes | SST is a 12-item survey that has a score up to 12 points |
Countries
United States
Outcome results
None listed