Shoulder InjuriesRTSA-RCRNCT06848023
Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+
An observational study of Shoulder Injuries and Shoulder Pain, run by Campbell Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Shoulder Injuries, Shoulder Pain
- What is being tested?
- Reverse Total Shoulder Arthroplasty and Rotator Cuff Repair
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects will be patients of either Dr. Brolin or Dr. Throckmorton who had either a reverse total shoulder arthroplasty or rotator cuff repair for treatment of a three tendon tear and are 60 years of age and older.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears
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.
Read the detailed description
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.
- Conditions
- Shoulder Injuries, Shoulder Pain
- Being tested
- Reverse Total Shoulder Arthroplasty, Rotator Cuff Repair
- Medical subject headings
- Shoulder Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total Shoulder ArthroplastyProcedure or surgery
standard of care treatment reverse total shoulder arthroplasty delivered
Rotator Cuff RepairProcedure or surgery
standard of care treatment rotator cuff repair delivered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Reverse Total Shoulder Arthroplasty | |
| 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. Receives: Procedure: Rotator Cuff Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder Elbow Surgeons
numeric scale to quantify shoulder function from zero (worst) to one hundred (best)
Measured: 90 days before surgery to day of surgery
American Shoulder Elbow Surgeons
numeric scale to quantify shoulder function from zero (worst) to one hundred (best)
Measured: one year after surgery
Visual Analog Scale
numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)
Measured: 90 days before surgery to day of surgery
Visual Analog Scale
numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)
Measured: one year after surgery
Single Assessment Numeric Evaluation
Satisfaction with Shoulder
Measured: 90 days before surgery to day of surgery
Single Assessment Numeric Evaluation
Satisfaction with Shoulder
Measured: one year after surgery
Secondary outcomes (4)
Revision rate
occurrence of repeat surgery
Measured: one year after surgery
Sugaya
Measure of tendon quality from one (intact) to five (completely torn)
Measured: one year after surgery
Range of motion
shoulder movement measurement
Measured: 90 day to surgery
Range of motion
shoulder movement measurement
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start10 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler J Brolin, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848023
- Sponsor's protocol ID
- 25-010480-XP
- Acronym
- RTSA-RCR
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared.
Publications
Allert JW, Sellers TR, Simon P, Christmas KN, Patel S, Frankle MA. Massive Rotator Cuff Tears in Patients Older Than Sixty-five: Indications for Cuff Repair versus Reverse Total Shoulder Arthroplasty. Am J Orthop (Belle Mead NJ). 2018 Dec;47(12). doi: 10.12788/ajo.2018.0109.
PubMed 30650169Jacquot A, Dezaly C, Goetzmann T, Roche O, Sirveaux F, Mole D; French Society for Shoulder, Elbow (SOFEC). Is rotator cuff repair appropriate in patients older than 60 years of age? prospective, randomised trial in 103 patients with a mean four-year follow-up. Orthop Traumatol Surg Res. 2014 Oct;100(6 Suppl):S333-8. doi: 10.1016/j.otsr.2014.04.004. Epub 2014 Aug 23.
PubMed 25155203Robinson PM, Wilson J, Dalal S, Parker RA, Norburn P, Roy BR. Rotator cuff repair in patients over 70 years of age: early outcomes and risk factors associated with re-tear. Bone Joint J. 2013 Feb;95-B(2):199-205. doi: 10.1302/0301-620X.95B2.30246.
PubMed 23365029Gowda CS, Mirza K, Galagali DA. Rotator Cuff Tears: Correlation Between Clinical Examination, Magnetic Resonance Imaging and Arthroscopy. Cureus. 2024 Mar 12;16(3):e56065. doi: 10.7759/cureus.56065. eCollection 2024 Mar.
PubMed 38618461Adam MF, Ladermann A, Denard PJ, Lacerda F, Collin P. Preoperative diagnosis and rotator cuff status impact functional internal rotation following reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2024 Jul;33(7):1570-1576. doi: 10.1016/j.jse.2023.11.020. Epub 2024 Jan 11.
PubMed 38218405
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Patients 60 Years of Age and Older: Reverse Total Shoulder Arthroplasty Versus Rotator Cuff Repair Involving Three Tendon Tears
- ClinicalTrials.gov ID
- NCT06848023
- Acronym / sponsor ID
- RTSA-RCR / 25-010480-XP
- Conditions
- Shoulder Injuries, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reverse Total Shoulder Arthroplasty | – | Procedure: Reverse Total Shoulder ArthroplastyRetrospective 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 | – | Procedure: Rotator Cuff RepairRetrospective 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. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects will be patients of either Dr. Brolin or Dr. Throckmorton who had either a reverse total shoulder arthroplasty or rotator cuff repair for treatment of a three tendon tear and are 60 years of age and older.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reverse Total Shoulder Arthroplastystandard of care treatment reverse total shoulder arthroplasty delivered | Procedure or surgery | Reverse Total Shoulder Arthroplasty |
| Rotator Cuff Repairstandard of care treatment rotator cuff repair delivered | Procedure or surgery | Rotator Cuff Repair |
Primary outcome
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)
American Shoulder Elbow Surgeons
Time frame: one year after surgery
numeric scale to quantify shoulder function from zero (worst) to one hundred (best)
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)
Visual Analog Scale
Time frame: one year after surgery
numeric scale to quantify shoulder pain from zero (no pain) to ten (worst pain)
Single Assessment Numeric Evaluation
Time frame: 90 days before surgery to day of surgery
Satisfaction with Shoulder
Single Assessment Numeric Evaluation
Time frame: one year after surgery
Satisfaction with Shoulder
4 secondary outcomes
Revision rate
Time frame: one year after surgery
Sugaya
Time frame: one year after surgery
Range of motion
Time frame: 90 day to surgery
Range of motion
Time frame: one year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 30650169Allert JW, Sellers TR, Simon P, Christmas KN, Patel S, Frankle MA. Massive Rotator Cuff Tears in Patients Older Than Sixty-five: Indications for Cuff Repair versus Reverse Total Shoulder Arthroplasty. Am J Orthop (Belle Mead NJ). 2018 Dec;47(12). doi: 10.12788/ajo.2018.0109.
- Results publication: PubMed 25155203Jacquot A, Dezaly C, Goetzmann T, Roche O, Sirveaux F, Mole D; French Society for Shoulder, Elbow (SOFEC). Is rotator cuff repair appropriate in patients older than 60 years of age? prospective, randomised trial in 103 patients with a mean four-year follow-up. Orthop Traumatol Surg Res. 2014 Oct;100(6 Suppl):S333-8. doi: 10.1016/j.otsr.2014.04.004. Epub 2014 Aug 23.
- Results publication: PubMed 23365029Robinson PM, Wilson J, Dalal S, Parker RA, Norburn P, Roy BR. Rotator cuff repair in patients over 70 years of age: early outcomes and risk factors associated with re-tear. Bone Joint J. 2013 Feb;95-B(2):199-205. doi: 10.1302/0301-620X.95B2.30246.
- Results publication: PubMed 38618461Gowda CS, Mirza K, Galagali DA. Rotator Cuff Tears: Correlation Between Clinical Examination, Magnetic Resonance Imaging and Arthroscopy. Cureus. 2024 Mar 12;16(3):e56065. doi: 10.7759/cureus.56065. eCollection 2024 Mar.
- Results publication: PubMed 38218405Adam MF, Ladermann A, Denard PJ, Lacerda F, Collin P. Preoperative diagnosis and rotator cuff status impact functional internal rotation following reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2024 Jul;33(7):1570-1576. doi: 10.1016/j.jse.2023.11.020. Epub 2024 Jan 11.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler J Brolin, MD principal investigator
Campbell Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injuries and Shoulder Pain, run by Campbell Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder Elbow Surgeons (time frame: 90 days before surgery to day of surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06848023, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.