Arthroplasty, Replacement, ShoulderNCT07815535
Three Year Outcomes After Shoulder Arthroplasty
An observational study of Arthroplasty, Replacement, Shoulder and Arthritis Shoulder, run by Vani Sabesan at 5 sites in United States.
Trial summary
The purpose of this multicenter observational cohort study is to evaluate three-year outcomes in adults who underwent anatomic or reverse total shoulder arthroplasty using a contemporary shoulder implant system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder, Arthritis Shoulder, Rotator Cuff Arthropathy
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2026to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be identified from a cohort of individuals who underwent either a total or reverse shoulder arthroplasty from 2020-2024 using a single innovative implant system, with a target enrollment of 300 patients. The cohort will include patients from participating sites and the data collected will be deidentified.
Who may be able to join
- Primary shoulder arthroplasty
- Age >18 years at the time of surgery
- At least 2 years from the date of surgery
Who cannot join
- Revision shoulder arthroplasty
- Acute fracture cases
- Inability to obtain consent for outcome collection
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Sabesan Orthopaedics Research Inc
Atlantis, Florida, 33462
Vani Sabesan, MD, 754-233-3658, sabesanorthoresearch@gmail.com
Somers Orthopaedic Surgery & Sports Medicine Group
Carmel, New York, 10512
Vani Sabesan, MD, 754-233-3658, sabesanorthoresearch@gmail.com
Tennessee Orthopaedic Alliance
Columbia, Tennessee, 38401
Vani Sabesan, MD, 754-233-3658, sabesanorthoresearch@gmail.com
Kansas City Orthopaedic Alliance
Leawood, Kansas, 66224
Vani Sabesan, MD, 754-233-3658, sabesanorthoresearch@gmail.com
Steindler Orthopaedic Clinic
North Liberty, Iowa, 52317
Vani Sabesan, MD, 754-233-3658, sabesanorthoresearch@gmail.com
About this study
Official title: Evaluating Three-Year Outcomes For Total Versus Reverse Shoulder Arthroplasty
The purpose of this multicenter observational cohort study is to evaluate three-year outcomes in adults who underwent anatomic or reverse total shoulder arthroplasty using a contemporary shoulder implant system. The main questions it aims to answer are:
Are three-year patient-reported outcomes after anatomic total shoulder arthroplasty comparable to those after reverse total shoulder arthroplasty? How often do the implants used during surgery differ from the preoperative three-dimensional (3D) surgical plan, and are these differences associated with patient outcomes, complications, or revision surgery?
Read more
Researchers will compare patient-reported outcomes, function, complications, and revision rates between patients who underwent anatomic and reverse total shoulder arthroplasty.
Researchers will review participant existing medical records and surgical information. Participants whose two- or three-year outcome measures are not available may be asked to complete a one-time questionnaire by telephone or secure electronic survey. No treatments or additional clinical procedures will be performed as part of this study.
Read the detailed description
Contemporary shoulder arthroplasty systems incorporate modular components, updated implant geometry, three-dimensional (3D)-printed technology, and preoperative 3D surgical planning to support patient-specific implant selection and intraoperative decision-making. Although these features are intended to improve procedural efficiency and flexibility, multicenter evidence regarding their clinical performance and associated patient outcomes remains limited.
This multicenter observational cohort study will evaluate patients who underwent primary anatomic total shoulder arthroplasty (aTSA) or reverse total shoulder arthroplasty (rTSA) using a single contemporary shoulder arthroplasty platform between 2020 and 2024. The study will combine retrospective review of existing clinical data with prospective collection of missing two- or three-year patient-reported outcome measures at a single follow-up time point. No investigational treatment, study-directed procedure, or alteration to routine clinical care will occur.
Existing electronic medical records, operative reports, imaging, preoperative planning files, implant information, and patient-reported outcome databases will be retrospectively reviewed. Data collected will include demographic and clinical characteristics, surgical and implant details, preoperative planning parameters, postoperative function, patient-reported outcomes, complications, readmissions, reoperations, and revisions. When two- or three-year patient-reported outcomes are not available through routine clinical follow-up, participants may be contacted to complete a one-time validated questionnaire by telephone or secure electronic survey.
The primary analysis will evaluate whether three-year outcomes after aTSA are non-inferior to those after rTSA using the American Shoulder and Elbow Surgeons score and a prespecified non-inferiority margin of 9 points. Additional analyses will compare functional outcomes, complications, and revision rates between the two procedure groups.
Among patients with available preoperative 3D planning data, the study will also evaluate agreement between the planned and implanted glenoid and humeral components. Investigators will characterize the frequency and types of intraoperative deviations from the surgical plan and assess whether these deviations are associated with postoperative outcomes, complications, patient satisfaction, or revision surgery. The target sample size is up to 300 participants, with approximately 150 participants in each procedure group.
- Keywords
- anatomic total shoulder arthroplasty, reverse total shoulder arthroplasty, shoulder replacement, patient-reported outcomes, preoperative planning, implant selection, shoulder prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anatomic Total Shoulder Arthroplasty | Patients who underwent primary anatomic total shoulder arthroplasty using the study implant platform between 2020 and 2024. | |
| Reverse Total Shoulder Arthroplasty | Patients who underwent primary reverse total shoulder arthroplasty using the study implant platform between 2020 and 2024. |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons (ASES) Score
The ASES score is a patient-reported measure of shoulder pain and function scored from 0 to 100, with higher scores indicating better outcomes. Three-year ASES scores will be compared between patients who underwent anatomic and reverse total shoulder arthroplasty.
Measured: Three Years Postoperatively
ASES Score
The ASES score is a patient-reported measure of shoulder pain and function scored from 0 to 100, with higher scores indicating better outcomes. Three-year ASES scores will be compared between patients who underwent anatomic and reverse total shoulder arthroplasty.
Measured: One Year, Two Years Postoperatively
Secondary outcomes (13)
Simple Shoulder Test score
The Simple Shoulder Test is a 12-item patient-reported assessment of shoulder function. Scores range from 0 to 12, with higher scores indicating better shoulder function.
Measured: One Year, Two Years, and Three Years Postoperatively
Single Assessment Numeric Evaluation score
Participants rate their shoulder function as a percentage of normal from 0 to 100, with higher scores indicating better perceived shoulder function.
Measured: One Year, Two Years, Three Years Postoperatively
Constant-Murley score
The Constant-Murley score evaluates shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better shoulder function.
Measured: One Year, Two Years, Three Years Postoperatively
PENN Shoulder Score
The Penn Shoulder Score evaluates shoulder pain, satisfaction, and function. Scores range from 0 to 100, with higher scores indicating better outcomes.
Measured: One Year, Two Years, Three Years Postoperatively
University of California Los Angeles Shoulder Score
The UCLA Shoulder Score evaluates pain, function, active forward flexion, strength, and patient satisfaction. Scores range from 0 to 35, with higher scores indicating better outcomes.
Measured: One Year, Two Years, Three Years Postoperatively
Shoulder Pain and Disability Index
The SPADI evaluates shoulder pain and disability. Scores range from 0 to 100, with higher scores indicating greater pain and disability.
Measured: One Year, Two Years, Three Years Postoperatively
Disabilities of the Arm, Shoulder and Hand Score
The DASH evaluates symptoms and difficulty performing upper-extremity activities. Scores range from 0 to 100, with higher scores indicating greater disability.
Measured: One Year, Two Years, Three Years Postoperatively
Western Ontario Osteoarthritis of the Shoulder Index
The WOOS evaluates shoulder-related physical symptoms, sports and recreation, work, and emotional function. Scores will be converted to a percentage from 0 to 100, with higher normalized scores indicating better shoulder-related quality of life.
Measured: One Year, Two Years, Three Years Postoperatively
Short Form-12 Outcome Score
The SF-12 evaluates general health-related quality of life and produces physical and mental component summary scores. Higher scores indicate better health-related quality of life.
Measured: One Year, Two Years, Three Years Postoperatively
Shoulder Range of Motion
Shoulder forward flexion, abduction, external rotation, and internal rotation will be obtained from available clinical records. Forward flexion, abduction, and external rotation will be measured in degrees, and each motion will be analyzed separately.
Measured: One, Two, Three Years Postoperatively
Postoperative Complications
The number and percentage of participants experiencing postoperative complications, including infection, dislocation or instability, scapular notching, acromial stress fracture, implant failure, or rotator cuff failure, will be assessed through review of existing clinical records.
Measured: From date of surgery to time of data abstraction
Revision Shoulder Surgery
The number and percentage of participants undergoing revision shoulder arthroplasty or another reoperation involving the operative shoulder will be assessed through review of existing clinical records.
Measured: From date of surgery through time of study completion, an average of three years
Concordance between planned and implanted components
Among participants with available preoperative three-dimensional planning data, the proportion of cases in which the planned glenoid and humeral component characteristics match the components implanted during surgery will be determined. The number and percentage of cases with one or more deviations from the preoperative surgical plan will be assessed.
Measured: Date of Index Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, ShoulderStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vani Sabesan
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor-investigator, Vani Sabesan, Sabesan Orthopaedics Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815535
- Sponsor's protocol ID
- SORE3Y001
- Other IDs
- DPS-JMP-CS-2025-015
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simovitch R, Flurin PH, Wright T, Zuckerman JD, Roche CP. Quantifying success after total shoulder arthroplasty: the minimal clinically important difference. J Shoulder Elbow Surg. 2018 Feb;27(2):298-305. doi: 10.1016/j.jse.2017.09.013. Epub 2017 Nov 20.
PubMed 29162305Baumgarten KM. Patients who have intraoperative deviations in their preoperative plan have inferior clinical and radiographic outcomes after anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2023 Sep;32(9):e451-e463. doi: 10.1016/j.jse.2023.01.035. Epub 2023 Mar 2.
PubMed 36868298Raiss P, Walch G, Wittmann T, Athwal GS. Is preoperative planning effective for intraoperative glenoid implant size and type selection during anatomic and reverse shoulder arthroplasty? J Shoulder Elbow Surg. 2020 Oct;29(10):2123-2127. doi: 10.1016/j.jse.2020.01.098. Epub 2020 Apr 25.
PubMed 32340791Lilley BM, Lachance A, Peebles AM, Powell SN, Romeo AA, Denard PJ, Provencher CMT. What is the deviation in 3D preoperative planning software? A systematic review of concordance between plan and actual implant in reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 May;31(5):1073-1082. doi: 10.1016/j.jse.2021.12.006. Epub 2022 Jan 10.
PubMed 35017079Hill JR, Jackson GR, To W, Zmistowski B, Movassaghi A, Sabesan VJ. Navigating the future: A comprehensive review of technology in shoulder arthroplasty. J Hand Microsurg. 2025 Feb 4;17(3):100224. doi: 10.1016/j.jham.2025.100224. eCollection 2025 May.
PubMed 40170673Barreto Vega A, Ramkumar PN, Kassam H, Navarro RA. Advanced technology in shoulder arthroplasty surgery: Artificial intelligence, extended reality, and robotics. Shoulder Elbow. 2024 Jul;16(4):347-351. doi: 10.1177/17585732241259165. Epub 2024 Jun 5.
PubMed 39318415Dragonas CG, Mamarelis G, Dott C, Waseem S, Bajracharya A, Leivadiotou D. Anatomic Total Shoulder Arthroplasty Versus Reverse Total Shoulder Arthroplasty in Patients Aged Over 70 Without a Full-Thickness Rotator Cuff Tear: A Systematic Review and Meta-Analysis. J Shoulder Elb Arthroplast. 2023 Oct 6;7:24715492231206685. doi: 10.1177/24715492231206685. eCollection 2023.
PubMed 37808225Beleckas CM, Schodlbauer DF, Mousad AD, Levy JC. Evaluation of new normal after shoulder arthroplasty: comparison of anatomic vs. reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2025 Jun;34(6S):S43-S49. doi: 10.1016/j.jse.2025.02.010. Epub 2025 Mar 10.
PubMed 40074195Sanchez-Sotelo J. Current Concepts in Humeral Component Design for Anatomic and Reverse Shoulder Arthroplasty. J Clin Med. 2021 Nov 2;10(21):5151. doi: 10.3390/jcm10215151.
PubMed 34768670Frank JK, Siegert P, Plachel F, Heuberer PR, Huber S, Schanda JE. The Evolution of Reverse Total Shoulder Arthroplasty-From the First Steps to Novel Implant Designs and Surgical Techniques. J Clin Med. 2022 Mar 10;11(6):1512. doi: 10.3390/jcm11061512.
PubMed 35329837Leafblad N, Asghar E, Tashjian RZ. Innovations in Shoulder Arthroplasty. J Clin Med. 2022 May 16;11(10):2799. doi: 10.3390/jcm11102799.
PubMed 35628933Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.
PubMed 32858194Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.
PubMed 22258770Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90(6):1244-51. doi: 10.2106/JBJS.G.00775.
PubMed 18519317Chelli M, Boileau P, Domos P, Clavert P, Berhouet J, Collin P, Walch G, Favard L. Survivorship of Reverse Shoulder Arthroplasty According to Indication, Age and Gender. J Clin Med. 2022 May 10;11(10):2677. doi: 10.3390/jcm11102677.
PubMed 35628804
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Three-Year Outcomes For Total Versus Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT07815535
- Acronym / sponsor ID
- SORE3Y001
- Keywords
- anatomic total shoulder arthroplasty, reverse total shoulder arthroplasty, shoulder replacement, patient-reported outcomes, preoperative planning, implant selection, shoulder prosthesis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vani SabesanUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Sep 2026 (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.
The purpose of this multicenter observational cohort study is to evaluate three-year outcomes in adults who underwent anatomic or reverse total shoulder arthroplasty using a contemporary shoulder implant system. The main questions it aims to answer are:
Are three-year patient-reported outcomes after anatomic total shoulder arthroplasty comparable to those after reverse total shoulder arthroplasty? How often do the implants used during surgery differ from the preoperative three-dimensional (3D) surgical plan, and are these differences associated with patient outcomes, complications, or revision surgery?
Researchers will compare patient-reported outcomes, function, complications, and revision rates between patients who underwent anatomic and reverse total shoulder arthroplasty.
Researchers will review participant existing medical records and surgical information. Participants whose two- or three-year outcome measures are not available may be asked to complete a one-time questionnaire by telephone or secure electronic survey. No treatments or additional clinical procedures will be performed as part of this study.
Detailed description
Contemporary shoulder arthroplasty systems incorporate modular components, updated implant geometry, three-dimensional (3D)-printed technology, and preoperative 3D surgical planning to support patient-specific implant selection and intraoperative decision-making. Although these features are intended to improve procedural efficiency and flexibility, multicenter evidence regarding their clinical performance and associated patient outcomes remains limited.
This multicenter observational cohort study will evaluate patients who underwent primary anatomic total shoulder arthroplasty (aTSA) or reverse total shoulder arthroplasty (rTSA) using a single contemporary shoulder arthroplasty platform between 2020 and 2024. The study will combine retrospective review of existing clinical data with prospective collection of missing two- or three-year patient-reported outcome measures at a single follow-up time point. No investigational treatment, study-directed procedure, or alteration to routine clinical care will occur.
Existing electronic medical records, operative reports, imaging, preoperative planning files, implant information, and patient-reported outcome databases will be retrospectively reviewed. Data collected will include demographic and clinical characteristics, surgical and implant details, preoperative planning parameters, postoperative function, patient-reported outcomes, complications, readmissions, reoperations, and revisions. When two- or three-year patient-reported outcomes are not available through routine clinical follow-up, participants may be contacted to complete a one-time validated questionnaire by telephone or secure electronic survey.
The primary analysis will evaluate whether three-year outcomes after aTSA are non-inferior to those after rTSA using the American Shoulder and Elbow Surgeons score and a prespecified non-inferiority margin of 9 points. Additional analyses will compare functional outcomes, complications, and revision rates between the two procedure groups.
Among patients with available preoperative 3D planning data, the study will also evaluate agreement between the planned and implanted glenoid and humeral components. Investigators will characterize the frequency and types of intraoperative deviations from the surgical plan and assess whether these deviations are associated with postoperative outcomes, complications, patient satisfaction, or revision surgery. The target sample size is up to 300 participants, with approximately 150 participants in each procedure group.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomic Total Shoulder Arthroplasty | – | –Patients who underwent primary anatomic total shoulder arthroplasty using the study implant platform between 2020 and 2024. |
| Reverse Total Shoulder Arthroplasty | – | –Patients who underwent primary reverse total shoulder arthroplasty using the study implant platform between 2020 and 2024. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be identified from a cohort of individuals who underwent either a total or reverse shoulder arthroplasty from 2020-2024 using a single innovative implant system, with a target enrollment of 300 patients. The cohort will include patients from participating sites and the data collected will be deidentified.
Key inclusion criteria (3 listed)
- Primary shoulder arthroplasty
- Age >18 years at the time of surgery
- At least 2 years from the date of surgery
Key exclusion criteria (3 listed)
- Revision shoulder arthroplasty
- Acute fracture cases
- Inability to obtain consent for outcome collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Three Years Postoperatively
The ASES score is a patient-reported measure of shoulder pain and function scored from 0 to 100, with higher scores indicating better outcomes. Three-year ASES scores will be compared between patients who underwent anatomic and reverse total shoulder arthroplasty.
ASES Score
Time frame: One Year, Two Years Postoperatively
The ASES score is a patient-reported measure of shoulder pain and function scored from 0 to 100, with higher scores indicating better outcomes. Three-year ASES scores will be compared between patients who underwent anatomic and reverse total shoulder arthroplasty.
13 secondary outcomes
Simple Shoulder Test score
Time frame: One Year, Two Years, and Three Years Postoperatively
Single Assessment Numeric Evaluation score
Time frame: One Year, Two Years, Three Years Postoperatively
Constant-Murley score
Time frame: One Year, Two Years, Three Years Postoperatively
PENN Shoulder Score
Time frame: One Year, Two Years, Three Years Postoperatively
University of California Los Angeles Shoulder Score
Time frame: One Year, Two Years, Three Years Postoperatively
Shoulder Pain and Disability Index
Time frame: One Year, Two Years, Three Years Postoperatively
Disabilities of the Arm, Shoulder and Hand Score
Time frame: One Year, Two Years, Three Years Postoperatively
Western Ontario Osteoarthritis of the Shoulder Index
Time frame: One Year, Two Years, Three Years Postoperatively
Short Form-12 Outcome Score
Time frame: One Year, Two Years, Three Years Postoperatively
Shoulder Range of Motion
Time frame: One, Two, Three Years Postoperatively
Postoperative Complications
Time frame: From date of surgery to time of data abstraction
Revision Shoulder Surgery
Time frame: From date of surgery through time of study completion, an average of three years
Concordance between planned and implanted components
Time frame: Date of Index 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 11 Sep 2026.
- Background: PubMed 29162305Simovitch R, Flurin PH, Wright T, Zuckerman JD, Roche CP. Quantifying success after total shoulder arthroplasty: the minimal clinically important difference. J Shoulder Elbow Surg. 2018 Feb;27(2):298-305. doi: 10.1016/j.jse.2017.09.013. Epub 2017 Nov 20.
- Background: PubMed 36868298Baumgarten KM. Patients who have intraoperative deviations in their preoperative plan have inferior clinical and radiographic outcomes after anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2023 Sep;32(9):e451-e463. doi: 10.1016/j.jse.2023.01.035. Epub 2023 Mar 2.
- Background: PubMed 32340791Raiss P, Walch G, Wittmann T, Athwal GS. Is preoperative planning effective for intraoperative glenoid implant size and type selection during anatomic and reverse shoulder arthroplasty? J Shoulder Elbow Surg. 2020 Oct;29(10):2123-2127. doi: 10.1016/j.jse.2020.01.098. Epub 2020 Apr 25.
- Background: PubMed 35017079Lilley BM, Lachance A, Peebles AM, Powell SN, Romeo AA, Denard PJ, Provencher CMT. What is the deviation in 3D preoperative planning software? A systematic review of concordance between plan and actual implant in reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 May;31(5):1073-1082. doi: 10.1016/j.jse.2021.12.006. Epub 2022 Jan 10.
- Background: PubMed 40170673Hill JR, Jackson GR, To W, Zmistowski B, Movassaghi A, Sabesan VJ. Navigating the future: A comprehensive review of technology in shoulder arthroplasty. J Hand Microsurg. 2025 Feb 4;17(3):100224. doi: 10.1016/j.jham.2025.100224. eCollection 2025 May.
- Background: PubMed 39318415Barreto Vega A, Ramkumar PN, Kassam H, Navarro RA. Advanced technology in shoulder arthroplasty surgery: Artificial intelligence, extended reality, and robotics. Shoulder Elbow. 2024 Jul;16(4):347-351. doi: 10.1177/17585732241259165. Epub 2024 Jun 5.
- Background: PubMed 37808225Dragonas CG, Mamarelis G, Dott C, Waseem S, Bajracharya A, Leivadiotou D. Anatomic Total Shoulder Arthroplasty Versus Reverse Total Shoulder Arthroplasty in Patients Aged Over 70 Without a Full-Thickness Rotator Cuff Tear: A Systematic Review and Meta-Analysis. J Shoulder Elb Arthroplast. 2023 Oct 6;7:24715492231206685. doi: 10.1177/24715492231206685. eCollection 2023.
- Background: PubMed 40074195Beleckas CM, Schodlbauer DF, Mousad AD, Levy JC. Evaluation of new normal after shoulder arthroplasty: comparison of anatomic vs. reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2025 Jun;34(6S):S43-S49. doi: 10.1016/j.jse.2025.02.010. Epub 2025 Mar 10.
- Background: PubMed 34768670Sanchez-Sotelo J. Current Concepts in Humeral Component Design for Anatomic and Reverse Shoulder Arthroplasty. J Clin Med. 2021 Nov 2;10(21):5151. doi: 10.3390/jcm10215151.
- Background: PubMed 35329837Frank JK, Siegert P, Plachel F, Heuberer PR, Huber S, Schanda JE. The Evolution of Reverse Total Shoulder Arthroplasty-From the First Steps to Novel Implant Designs and Surgical Techniques. J Clin Med. 2022 Mar 10;11(6):1512. doi: 10.3390/jcm11061512.
- Background: PubMed 35628933Leafblad N, Asghar E, Tashjian RZ. Innovations in Shoulder Arthroplasty. J Clin Med. 2022 May 16;11(10):2799. doi: 10.3390/jcm11102799.
- Background: PubMed 32858194Best MJ, Aziz KT, Wilckens JH, McFarland EG, Srikumaran U. Increasing incidence of primary reverse and anatomic total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2021 May;30(5):1159-1166. doi: 10.1016/j.jse.2020.08.010. Epub 2020 Aug 26.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Shoulder and Arthritis Shoulder, run by Vani Sabesan at 5 sites 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 3 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Vani J Sabesan, MD (754-233-3658, sabes001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Score (time frame: Three Years Postoperatively). The study lists 2 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 NCT07815535, which also lists 16 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 11 Sep 2026.