Three Year Outcomes After Shoulder Arthroplasty
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?
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Vani J Sabesan, MD
- Telefonnummer: 754-233-3658
- E-post: sabes001@gmail.com
Studiesteder
-
-
Florida
-
Atlantis, Florida, Forente stater, 33462
- Sabesan Orthopaedics Research Inc
-
Ta kontakt med:
- Vani Sabesan, MD
- Telefonnummer: 754-233-3658
- E-post: sabesanorthoresearch@gmail.com
-
-
Iowa
-
North Liberty, Iowa, Forente stater, 52317
- Steindler Orthopaedic Clinic
-
Ta kontakt med:
- Vani Sabesan, MD
- Telefonnummer: 754-233-3658
- E-post: sabesanorthoresearch@gmail.com
-
-
Kansas
-
Leawood, Kansas, Forente stater, 66224
- Kansas City Orthopaedic Alliance
-
Ta kontakt med:
- Vani Sabesan, MD
- Telefonnummer: 754-233-3658
- E-post: sabesanorthoresearch@gmail.com
-
-
New York
-
Carmel, New York, Forente stater, 10512
- Somers Orthopaedic Surgery & Sports Medicine Group
-
Ta kontakt med:
- Vani Sabesan, MD
- Telefonnummer: 754-233-3658
- E-post: sabesanorthoresearch@gmail.com
-
-
Tennessee
-
Columbia, Tennessee, Forente stater, 38401
- Tennessee Orthopaedic Alliance
-
Ta kontakt med:
- Vani Sabesan, MD
- Telefonnummer: 754-233-3658
- E-post: sabesanorthoresearch@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Primary shoulder arthroplasty
- Age >18 years at the time of surgery
- At least 2 years from the date of surgery
Exclusion Criteria:
- Revision shoulder arthroplasty
- Acute fracture cases
- Inability to obtain consent for outcome collection
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Score
Tidsramme: 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.
|
Three Years Postoperatively
|
|
ASES Score
Tidsramme: 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.
|
One Year, Two Years Postoperatively
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Simple Shoulder Test score
Tidsramme: One Year, Two Years, and Three Years Postoperatively
|
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.
|
One Year, Two Years, and Three Years Postoperatively
|
|
Single Assessment Numeric Evaluation score
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
Participants rate their shoulder function as a percentage of normal from 0 to 100, with higher scores indicating better perceived shoulder function.
|
One Year, Two Years, Three Years Postoperatively
|
|
Constant-Murley score
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
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.
|
One Year, Two Years, Three Years Postoperatively
|
|
PENN Shoulder Score
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
The Penn Shoulder Score evaluates shoulder pain, satisfaction, and function.
Scores range from 0 to 100, with higher scores indicating better outcomes.
|
One Year, Two Years, Three Years Postoperatively
|
|
University of California Los Angeles Shoulder Score
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
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.
|
One Year, Two Years, Three Years Postoperatively
|
|
Shoulder Pain and Disability Index
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
The SPADI evaluates shoulder pain and disability.
Scores range from 0 to 100, with higher scores indicating greater pain and disability.
|
One Year, Two Years, Three Years Postoperatively
|
|
Disabilities of the Arm, Shoulder and Hand Score
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
The DASH evaluates symptoms and difficulty performing upper-extremity activities.
Scores range from 0 to 100, with higher scores indicating greater disability.
|
One Year, Two Years, Three Years Postoperatively
|
|
Western Ontario Osteoarthritis of the Shoulder Index
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
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.
|
One Year, Two Years, Three Years Postoperatively
|
|
Short Form-12 Outcome Score
Tidsramme: One Year, Two Years, Three Years Postoperatively
|
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.
|
One Year, Two Years, Three Years Postoperatively
|
|
Shoulder Range of Motion
Tidsramme: One, Two, Three Years Postoperatively
|
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.
|
One, Two, Three Years Postoperatively
|
|
Postoperative Complications
Tidsramme: From date of surgery to time of data abstraction
|
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.
|
From date of surgery to time of data abstraction
|
|
Revision Shoulder Surgery
Tidsramme: From date of surgery through time of study completion, an average of three years
|
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.
|
From date of surgery through time of study completion, an average of three years
|
|
Concordance between planned and implanted components
Tidsramme: Date of Index Surgery
|
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.
|
Date of Index Surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kim 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.
- 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.
- Best 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.
- Baumgarten 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.
- Raiss 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.
- Lilley 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.
- Hill 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.
- Barreto 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.
- Dragonas 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.
- Beleckas 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.
- Sanchez-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.
- Frank 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.
- Leafblad N, Asghar E, Tashjian RZ. Innovations in Shoulder Arthroplasty. J Clin Med. 2022 May 16;11(10):2799. doi: 10.3390/jcm11102799.
- Cuff 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.
- Chelli 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.
- Jo YH, Kim DH, Lee BG. When should reverse total shoulder arthroplasty be considered in glenohumeral joint arthritis? Clin Shoulder Elb. 2021 Dec;24(4):272-278. doi: 10.5397/cise.2021.00633. Epub 2021 Dec 1.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- SORE3Y001
- DPS-JMP-CS-2025-015 (Annet stipend/finansieringsnummer: DePuy Synthes)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .