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Enrolling by Invitation

NCT Number: NCT06848023

Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+

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.

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Key information

Conditions

Shoulder Injuries Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Wounds and Injuries

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Campbell Clinic

Germantown, Tennessee, 38138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reverse Total Shoulder Arthroplasty

Procedure

standard of care treatment reverse total shoulder arthroplasty delivered

Rotator Cuff Repair

Procedure

standard of care treatment rotator cuff repair delivered

Primary outcomes

  1. American Shoulder Elbow Surgeons

    Time frame: 90 days before surgery to day of surgery

    numeric scale to quantify shoulder function from zero (worst) to one hundred (best)

  2. American Shoulder Elbow Surgeons

    Time frame: one year after surgery

    numeric scale to quantify shoulder function from zero (worst) to one hundred (best)

  3. Visual Analog Scale

    Time frame: 90 days before surgery to day of surgery

    numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)

  4. Visual Analog Scale

    Time frame: one year after surgery

    numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)

  5. Single Assessment Numeric Evaluation

    Time frame: 90 days before surgery to day of surgery

    Satisfaction with Shoulder

  6. Single Assessment Numeric Evaluation

    Time frame: one year after surgery

    Satisfaction with Shoulder

Secondary outcomes

  1. Revision rate

    Time frame: one year after surgery

    occurrence of repeat surgery

  2. Sugaya

    Time frame: one year after surgery

    Measure of tendon quality from one (intact) to five (completely torn)

  3. Range of motion

    Time frame: 90 day to surgery

    shoulder movement measurement

  4. Range of motion

    Time frame: one year after surgery

    shoulder movement measurement

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears

Acronym: RTSA-RCR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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