Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+

Study Purpose

To compare the one year outcomes between 60 year old patients with a three tendon tear treated as part of their standard of care with either a reverse total shoulder arthroplasty or rotator cuff repair surgery.

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.	Observational
Eligible Ages	60 Years - 95 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 60 years of age or more at time of surgery.

- One year post-reverse total shoulder arthroplasty or one year post-rotator cuff repair involving all three tendons (infraspinatus, supraspinatus, subscapularis) - Surgery completed by Dr.

Tyler Brolin or Dr. Thomas Throckmorton.

Exclusion Criteria:

- Less than 60 years of age at time of surgery.

- Less than one year post-reverse total shoulder arthroplasty or post-rotator cuff repair.

- Procedure completed by another provider than Dr.

Brolin or Dr. Throckmorton.

- Worker's compensation.

- Fewer than three tendon tear

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.	NCT06848023
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.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Campbell Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tyler J Brolin, MD
Principal Investigator Affiliation	Campbell Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Shoulder Injuries, Shoulder Pain

Additional Details

A retrospective record review will be completed to identify eligible subjects who had either a reverse total shoulder arthroplasty or rotator cuff repair to treat their three tendon tear. Medical record abstraction of standard of care will be completed among the reverse total shoulder arthroplasty cohort. Rotator cuff repair subjects will be contacted with a study invitation and scheduled for a single study visit to collect three patient reported outcomes, assess range of motion and complete a ten-minute magnetic resonance imaging exam following signed consent.

Arms & Interventions

Arms

: Reverse Total Shoulder Arthroplasty

Retrospective record review and data abstraction of standard of care data preoperative and at least one year postoperative to include patient reported outcomes and range of motion measurements.

: Rotator Cuff Repair

Retrospective record review and data abstraction of standard of care data preoperative to include patient reported outcomes and range of motion measurements. Study invitation will be extended to subjects for completion of a single study visit to collect three patient reported outcomes, range of motion and a ten minute magnetic resonance imaging exam.

Interventions

Procedure: - Reverse Total Shoulder Arthroplasty

standard of care treatment reverse total shoulder arthroplasty delivered

Procedure: - Rotator Cuff Repair

standard of care treatment rotator cuff repair delivered

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.

Campbell Clinic, Germantown 4624601, Tennessee 4662168

Status

Address

Campbell Clinic

Germantown 4624601, Tennessee 4662168, 38138

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