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Novel vs Traditional Sling After Shoulder Surgery

N/A
Recruiting
Research Sponsored by Orthopedic Institute, Sioux Falls, SD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing arthroscopic rotator cuff repair and anatomic total shoulder arthroplasty
Dominant extremity undergoing surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after surgery
Awards & highlights

Study Summary

This trial will compare a new type of shoulder sling to a traditional one to see which gives better patient satisfaction while still having good postoperative outcomes.

Who is the study for?
This trial is for individuals having surgery on their dominant shoulder due to rotator cuff tears or osteoarthritis. They must understand English and be willing to follow the study's procedures. People with previous shoulder surgeries, significant neck spine disease, nerve damage in the arms, or wrist/elbow disorders cannot participate.Check my eligibility
What is being tested?
The study aims to see if a new type of shoulder sling gives better patient satisfaction than the traditional one after keyhole surgery for rotator cuff repair or total shoulder replacement. It will check if both slings result in similar recovery outcomes.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing the sling, limited mobility issues during recovery, and possible skin irritation under where the sling sits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery for a shoulder injury or shoulder replacement.
Select...
My surgery is on my dominant hand or leg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after 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
Patient choice of type of sling to utilize from postoperative days 29-42
Sling satisfaction survey
Secondary outcome measures
Elbow
Shoulder Activity Level
Single Assessment Numeric Evaluation

Trial Design

2Treatment groups
Experimental Treatment
Group I: Initial Postoperative Immobilization with the standard abduction slingExperimental Treatment1 Intervention
20 patients will be placed in the traditional abduction sling after surgery for the first two weeks. For the second two weeks (days 15-28) they will crossover and utilize the novel sling. For the final two weeks (days 29-42) they will choose their preferred sling type and use it for the remainder of six week immobilization period.
Group II: Initial Immobilization with the novel slingExperimental Treatment1 Intervention
20 patients will be placed in the novel sling after surgery for the first two weeks. For the second two weeks (days 15-28) they will crossover and utilize the standard abduction sling. For the final two weeks (days 29-42) they will choose their preferred sling type and use it for the remainder of six week immobilization period.

Find a Location

Who is running the clinical trial?

Orthopedic Institute, Sioux Falls, SDLead Sponsor
4 Previous Clinical Trials
2,953 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
400 Patients Enrolled for Rotator Cuff Tears

Media Library

Novel sling Clinical Trial Eligibility Overview. Trial Name: NCT05274737 — N/A
Rotator Cuff Tears Research Study Groups: Initial Immobilization with the novel sling, Initial Postoperative Immobilization with the standard abduction sling
Rotator Cuff Tears Clinical Trial 2023: Novel sling Highlights & Side Effects. Trial Name: NCT05274737 — N/A
Novel sling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05274737 — N/A

Frequently Asked Questions

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

How many participants are allowed to be included in this experiment?

"Affirmative. The information housed on clinicaltrials.gov confirms that this trial, inaugurated on March 1st 2022 and subsequently modified June 13th 2022, is actively recruiting participants from one location with a total target of 40 individuals."

Answered by AI

Is it currently possible to enroll in this trial?

"Affirmative. The clinicaltrials.gov website confirms that this scientific investigation is presently enrolling participants; it was first advertised on March 1st 2022, with the most recent update being June 13th 2022. Forty patients must be found at a single site for successful completion of the trial."

Answered by AI
~13 spots leftby Mar 2025