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No Sling for Rotator Cuff Tears

N/A

Recruiting

Led By Oke A Anakwenze, MD, MBA

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Glenohumeral arthritis

Patient is between 18-100 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to the first 2 years following surgery

Awards & highlights

Study Summary

This trial at Duke University is studying the effects of wearing a sling after reverse total shoulder replacement surgery. 100 eligible patients will be randomly assigned to wear a sling for 4 weeks or for 3 days.

Who is the study for?

This trial is for English-speaking adults aged 18-100 who are scheduled for a primary reverse shoulder arthroplasty at Duke University. They must live within 20 miles of RTP, be willing to attend physical therapy at Duke, and can fill out questionnaires and follow the study's visit schedule.Check my eligibility

What is being tested?

The study compares two post-surgery practices: one group will wear a sling for four weeks after shoulder replacement surgery, while the other will use it only until their nerve block wears off or up to three days post-surgery.See study design

What are the potential side effects?

Since this trial involves wearing a sling versus not wearing one after surgery, side effects may include discomfort from using or not using the sling, potential differences in recovery times or mobility issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have arthritis in my shoulder joint.

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I am between 18 and 100 years old.

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I have shoulder joint damage due to rotator cuff issues.

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I am scheduled for a specific shoulder replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to the first 2 years following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to the first 2 years following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to the first 2 years following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who develop any kind of postoperative complication

Secondary outcome measures

American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score

Single Assessment Numeric Evaluation (SANE) score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: No SlingExperimental Treatment1 Intervention

Participants in the no sling group will only wear a sling for three days postoperatively

Group II: SlingActive Control1 Intervention

Participants in the sling group will wear a sling according to current standard of care: 3 weeks postoperatively (2 weeks all the time, 3rd week at night and while in the community)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,416 Total Patients Enrolled

3 Trials studying Rotator Cuff Tears

185 Patients Enrolled for Rotator Cuff Tears

Oke A Anakwenze, MD, MBAPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any fresh participants being sought for this clinical trial?

"According to information made available on clinicaltrials.gov, this research project is currently in the process of recruiting participants. The original post was published December 1st 2023 and the trial has been updated most recently on December 7th 2023."

Answered by AI

Could someone aged 50+ partake in this test?

"This medical trial mandates that enrollees are of legal age (18+) to 100 years old. There also exist 7 separate studies for those below 18, and 133 additional trials designed specifically for aged patients over 65."

Answered by AI

How many individuals have received treatment in this medical experiment?

"Indeed, according to the information posted on clinicaltrials.gov, recruitment for this trial is currently underway. It was initially listed on December 1st 2023 and most recently updated seven days later. A total of 100 patients are needed at one site in order to complete the study."

Answered by AI

What qualifications are necessary to participate in this experiment?

"This clinical trial is searching for 100 individuals between the ages of 18 and 100 that suffer from cuff tear arthropathy. Eligible applicants must satisfy a number of criteria, including being scheduled to have primary reverse shoulder arthroplasty surgery, verbally consenting to participate in the study whilst possessing both mental and physical ability to do so, living within 20 miles of RTP, speaking English fluently as well as willing adhere their post-operative physical therapy regimen at Duke University."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sling vs No Sling After Reverse Total Shoulder Arthroplasty

2023. "Sling vs No Sling After Reverse Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06092996.