Clinical trial NCT05558579: Use of Postop Sling After Biceps Tenodesis
Official title: Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Biceps Tenodesis
Keywords: shoulder rehabilitation
shoulder sling
biceps disorders
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.)

Primary outcomes:
measure: Percent of Complications As Measured by Medical Records
timeFrame: Up to 2 years
measure: Degrees of Range-of-Motion As Measured by Physical Exam
timeFrame: Up to 30 minutes
measure: Strength as Measured by Physical Exam
timeFrame: Up to 30 minutes
Secondary outcomes:
measure: Pain as Measured by the Visual Analog Scale
timeFrame: Up to 5 minutes
measure: Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES)
timeFrame: Up to 15 minutes
measure: Shoulder Function as Measured by the Simple Shoulder Test (SST)
timeFrame: Up to 15 minutes
measure: Shoulder Function as Measured by Constant Murley Score (CMS)
timeFrame: Up to 15 minutes
measure: Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index
timeFrame: Up to 15 minutes
measure: Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE)
timeFrame: Up to 5 minutes
measure: Percent of Patients Satisfied as Measured by Patient Survey
timeFrame: Up to 5 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
affiliation: University Hospitals
name: Michael Karns, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals
name: Kallie Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: