---
title: Use of Postop Sling After Biceps Tenodesis
nct_id: NCT05558579
overall_status: WITHDRAWN
phase: NA
sponsor: University Hospitals Cleveland Medical Center
study_type: INTERVENTIONAL
primary_condition: Biceps Tenodesis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05558579.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05558579"
ct_last_update_post_date: 2024-04-24
last_seen_at: "2026-05-12T06:59:10.913Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Use of Postop Sling After Biceps Tenodesis

**Official Title:** Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis

**NCT ID:** [NCT05558579](https://clinicaltrials.gov/study/NCT05558579)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Unable to enroll participants
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** University Hospitals Cleveland Medical Center
- **Conditions:** Biceps Tenodesis
- **Start Date:** 2023-03-23
- **Completion Date:** 2024-09-26
- **CT.gov Last Update:** 2024-04-24

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 89 Years
- **Sex:** ALL
- **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.)
```

## Arms

- **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.

## Interventions

- **No sling use** (OTHER) — Patients will not use standard of care sling

## Primary Outcomes

- **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

## 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)_

## Locations (1)

- University Hospitals, Cleveland, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospitals|cleveland|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05558579.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05558579*  
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