Sling vs No Sling After Reverse Total Shoulder Arthroplasty

Study Purpose

This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient is scheduled to undergo a primary reverse shoulder arthroplasty procedure.
  • - Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
  • - Patient meets indications for primary reverse shoulder arthroplasty for the following diagnosis.
  • - Rotator cuff arthropathy.
  • - Glenohumeral arthritis.
  • - Patient is between 18-100 years old.
  • - Patient is English speaking.

Exclusion Criteria:

  • - A history of ipsilateral shoulder arthroplasty.
  • - A history of shoulder septic arthritis.
  • - A history of a proximal humeral fracture.
  • - Chronic locked dislocation.
  • - Rheumatoid arthritis.
  • - Tumors.
  • - Axillary nerve damage.
  • - Non-functioning deltoid muscle.
  • - Glenoid vault deficiency precluding baseplate fixation.
  • - Infection and neuropathic joints.
  • - Known or suspected non-compliance, drug or alcohol abuse.
  • - Patients incapable of judgement or under tutelage.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for imaging etc. - The subject is related to investigator as family members, employees, or other dependent persons

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06092996
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Oke A Anakwenze, MD, MBA
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Shoulder Disease, Rotator Cuff Tear Arthropathy, Shoulder Osteoarthritis
Additional Details

The purpose of this study is to determine whether or not a sling is necessary after the nerve block has worn off postoperatively for patients undergoing reverse total shoulder arthroplasty. Patients who are scheduled for a reverse total shoulder with the participating investigators will be approached for potential participation in the study. Before the surgery, subjects will be randomly assigned to either the Sling (control) group or the No-Sling (investigational) group. The Sling, or control, group will wear a sling through 3 weeks postoperatively. The No Sling (investigational) group, will wear a sling either through 3 days postoperatively. Following surgery, patients will be followed at their standard of care visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after their surgical date. The investigators will collect data from these standard of care visits including PROs (including but not limited to ASES and SANE), Adverse events data, and physical exam data including range of motion. Patients will be followed through their two-year visit and then taken off study.

Arms & Interventions

Arms

No Intervention: Sling

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)

Experimental: No Sling

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

Interventions

Other: - Time of Sling Use

Standard sling worn for only three days post operatively

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 27708

Site Contact

Caroline Questell, BSN

[email protected]

919-613-3670