Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023.0616 | Other Identifier | METC Amsterdam UMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Isala | OTHER |
| Enovis | INDUSTRY |
Not provided
Not provided
Not provided
Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty. Multicentre, stratified block randomization with variable block sizes; patient- and assessor-blinded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard cemented all-polyethylene pegged glenoid | Active Comparator | Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid. |
|
| Hybrid trabecular titanium central-peg glenoid | Experimental | Hybrid trabecular titanium central-peg glenoid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid | Procedure | Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept). |
| Measure | Description | Time Frame |
|---|---|---|
| Constant-Murley Score (shoulder function) | Clinical shoulder function assessed with the Constant-Murley Score (absolute and age/sex-adjusted) comparing hybrid versus standard glenoid fixation after anatomic total shoulder arthroplasty. The Constant-Murley Score ranges from 0 to 100 points, with 0 indicating the worst outcome and 100 indicating the best shoulder function. | Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder range of motion | Active shoulder range of motion (e.g., forward flexion, abduction, external/internal rotation) assessed clinically to compare recovery between glenoid groups. | Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively. |
| Oxford Shoulder Score questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Number of implant-related complications | Number of implant-related complications recorded from surgery through 10 years postoperatively. | From surgery through 10 years postoperatively. |
| Number of non-implant-related complications |
Inclusion Criteria:
-
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaarne Gasthuis | Recruiting | Hoofddorp | North Holland | 2134 TM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34147071 | Background | Sheikhzadeh A, Wertli MM, Weiner SS, Rasmussen-Barr E, Weiser S. Do psychological factors affect outcomes in musculoskeletal shoulder disorders? A systematic review. BMC Musculoskelet Disord. 2021 Jun 19;22(1):560. doi: 10.1186/s12891-021-04359-6. | |
| 12107318 | Background | Lazarus MD, Jensen KL, Southworth C, Matsen FA 3rd. The radiographic evaluation of keeled and pegged glenoid component insertion. J Bone Joint Surg Am. 2002 Jul;84(7):1174-82. doi: 10.2106/00004623-200207000-00013. |
Not provided
Not provided
De-identified IPD will not be shared because the protocol does not include an IPD-sharing plan and participant data are handled as coded personal data under GDPR/AVG with access restricted to authorized study personnel; any data transfer is limited to protocol-defined purposes (e.g., publication support).
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2024 | Feb 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2024 | Apr 1, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid | Procedure | Stemless anatomic total shoulder arthroplasty (SMR system) with a hybrid polyethylene glenoid: porous trabecular titanium central peg intended for bone ingrowth plus cemented peripheral pegs. |
|
Patient-reported shoulder pain and function measured with the Oxford Shoulder Score, comparing both glenoid fixation concepts. The Oxford Shoulder Score ranges from 0 to 48 points, with higher scores indicating a better outcome / better shoulder function. This is inferred from the 12-item questionnaire with 5 response options per item shown in the uploaded form. |
| Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively. |
| Hospital Anxiety subscale questionnaire | Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-D), a 7-item subscale of the full questionnaire. The Hospital Anxiety and Depression Scale is generally interpreted per subscale rather than as a single total score. The Anxiety and Depression subscales are assessed separately, each ranging from 0 to 21 points, with higher scores indicating more symptoms and therefore a worse outcome. | Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively. |
| Hospital Depression subscale questionnaire | Depressive symptoms assessed with the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D), a 7-item subscale of the full questionnaire. The Hospital Anxiety and Depression Scale is generally interpreted per subscale rather than as a single total score. The Anxiety and Depression subscales are assessed separately, each ranging from 0 to 21 points, with higher scores indicating more symptoms and therefore a worse outcome. | Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively. |
| Subjective Shoulder Value Scale | Patient-rated shoulder function as a percentage of normal (0-100%), comparing treatment arms. The Subjective Shoulder Value ranges from 0% to 100%, with higher percentages indicating better perceived shoulder function. | Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively. |
| Health-related quality of life - EuroQol-5D descriptive system | Health-related quality of life assessed with the EuroQol-5D descriptive system, which includes five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-level scale ranging from no problems to extreme problems. The combination of responses across the five domains is used to generate one overall health-state profile rather than a simple summed total score. | Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively. |
| Health-related quality of life - EuroQol-5D Visual Analogue Scal | Generic quality-of-life measured with the EQ-5D to compare overall health status between study arms.The EQ-5D visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health. | Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively. |
| Work-Related Questionnaire for Upper Extremity Disorders | Work limitations related to upper-extremity function assessed with the WRFQ-UE. The WorkQ-up consists of 17 items scored from 0 to 5 (or marked not applicable), resulting in a total score range of 0 to 85 if all items are applicable, with higher scores indicating more difficulty at work and therefore a worse outcome. | Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively. |
| Work Ability (single-item Work Ability Score) numeric scale | Self-rated work ability assessed with a single-item Work Ability Score to evaluate work capacity over time. The Work Ability Score ranges from 0 to 10 points, with higher scores indicating better work ability and therefore a better outcome. | Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively. |
| Implant survival (radiographic loosening endpoint) | Time-to-event implant survival where failure is defined as radiographic loosening and/or revision as specified in the protocol; compared between arms. | Up to 10 years postoperatively. |
Number of non-implant-related complications recorded from surgery through 10 years postoperatively.
| From surgery through 10 years postoperatively. |
| Number of implant-related adverse events | Number of implant-related adverse events recorded from surgery through 10 years postoperatively. | From surgery through 10 years postoperatively. |
| Number of non-implant-related adverse events | Number of non-implant-related adverse events recorded from surgery through 10 years postoperatively. | From surgery through 10 years postoperatively. |
| 24321169 | Background | Youderian AR, Ricchetti ET, Drews M, Iannotti JP. Determination of humeral head size in anatomic shoulder replacement for glenohumeral osteoarthritis. J Shoulder Elbow Surg. 2014 Jul;23(7):955-63. doi: 10.1016/j.jse.2013.09.005. Epub 2013 Dec 8. |
| 31897278 | Background | Beck S, Martin RJ, Patsalis T, Burggraf M, Busch A, Landgraeber S, Alexander W. Determination of humeral inclination in stemless shoulder arthroplasty using plain radiographs. Orthop Rev (Pavia). 2019 Dec 2;11(4):8194. doi: 10.4081/or.2019.8194. eCollection 2019 Dec 2. |
| 34315280 | Background | Werthel JD, Boux de Casson F, Burdin V, Athwal GS, Favard L, Chaoui J, Walch G. CT-based volumetric assessment of rotator cuff muscle in shoulder arthroplasty preoperative planning. Bone Jt Open. 2021 Jul;2(7):552-561. doi: 10.1302/2633-1462.27.BJO-2021-0081.R1. |
| 27282738 | Background | Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016 Oct;25(10):1601-6. doi: 10.1016/j.jse.2016.03.010. Epub 2016 Jun 6. |
| 10512449 | Background | Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2. |
| 35671925 | Background | Levin JM, Rodriguez K, Polascik BA, Zeng S, Warren E Jr, Rechenmacher A, Helmkamp J, Goltz DE, Wickman J, Klifto CS, Lassiter TE, Anakwenze O. Simple preoperative radiographic and computed tomography measurements predict adequate bone quality for stemless total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Dec;31(12):2481-2487. doi: 10.1016/j.jse.2022.05.008. Epub 2022 Jun 4. |
| 17638005 | Background | Sluiter JK, Frings-Dresen MH. Quality of life and illness perception in working and sick-listed chronic RSI patients. Int Arch Occup Environ Health. 2008 Feb;81(4):495-501. doi: 10.1007/s00420-007-0222-z. Epub 2007 Jul 19. |
| 23565883 | Background | El Fassi M, Bocquet V, Majery N, Lair ML, Couffignal S, Mairiaux P. Work ability assessment in a worker population: comparison and determinants of Work Ability Index and Work Ability score. BMC Public Health. 2013 Apr 8;13:305. doi: 10.1186/1471-2458-13-305. |
| 1514096 | Background | Ilmarinen J, Tuomi K. Work ability of aging workers. Scand J Work Environ Health. 1992;18 Suppl 2:8-10. No abstract available. |
| 29678451 | Background | Aerts BR, Kuijer PP, Beumer A, Eygendaal D, Frings-Dresen MH. WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP): Factor Analysis and Internal Consistency. Arch Phys Med Rehabil. 2018 Sep;99(9):1818-1826. doi: 10.1016/j.apmr.2018.03.013. Epub 2018 Apr 17. |
| 6880820 | Background | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. |
| 10109801 | Background | EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. |
| 10724223 | Background | Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000 Mar;82(3):304-14. doi: 10.2106/00004623-200003000-00002. |
| 20421170 | Background | Berendes T, Pilot P, Willems J, Verburg H, te Slaa R. Validation of the Dutch version of the Oxford Shoulder Score. J Shoulder Elbow Surg. 2010 Sep;19(6):829-36. doi: 10.1016/j.jse.2010.01.017. Epub 2010 Apr 24. |
| 8682827 | Background | Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996 Jul;78(4):593-600. |
| 15889027 | Background | Katolik LI, Romeo AA, Cole BJ, Verma NN, Hayden JK, Bach BR. Normalization of the Constant score. J Shoulder Elbow Surg. 2005 May-Jun;14(3):279-85. doi: 10.1016/j.jse.2004.10.009. |
| 3791738 | Background | Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. |
| 11408901 | Background | Antuna SA, Sperling JW, Cofield RH, Rowland CM. Glenoid revision surgery after total shoulder arthroplasty. J Shoulder Elbow Surg. 2001 May-Jun;10(3):217-24. doi: 10.1067/mse.2001.113961. |
| 25870114 | Background | Habermeyer P, Lichtenberg S, Tauber M, Magosch P. Midterm results of stemless shoulder arthroplasty: a prospective study. J Shoulder Elbow Surg. 2015 Sep;24(9):1463-72. doi: 10.1016/j.jse.2015.02.023. Epub 2015 Apr 11. |
| 27053583 | Background | Churchill RS, Chuinard C, Wiater JM, Friedman R, Freehill M, Jacobson S, Spencer E Jr, Holloway GB, Wittstein J, Lassiter T, Smith M, Blaine T, Nicholson GP. Clinical and Radiographic Outcomes of the Simpliciti Canal-Sparing Shoulder Arthroplasty System: A Prospective Two-Year Multicenter Study. J Bone Joint Surg Am. 2016 Apr 6;98(7):552-60. doi: 10.2106/JBJS.15.00181. |
| 29162305 | Background | 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. |
| 32529404 | Background | Malahias MA, Kostretzis L, Gkiatas I, Chronopoulos E, Brilakis E, Antonogiannakis E. Total shoulder arthroplasty with hybrid fixation of glenoid components consisting of cementless porous metal pegs or cage along with cemented backside polyethylene surface: a systematic review. Musculoskelet Surg. 2020 Dec;104(3):229-236. doi: 10.1007/s12306-020-00670-y. Epub 2020 Jun 11. |
| 35645649 | Background | Haleem A, Sedrak P, Gohal C, Athwal GS, Khan M, Alolabi B. Hybrid Glenoid Designs in Anatomic Total Shoulder Arthroplasty: A Systematic Review. HSS J. 2022 May;18(2):219-228. doi: 10.1177/15563316211040829. Epub 2021 Sep 3. |
| 32564898 | Background | Sharplin PK, Frampton CMA, Hirner M. Cemented vs. uncemented glenoid fixation in total shoulder arthroplasty for osteoarthritis: a New Zealand Joint Registry study. J Shoulder Elbow Surg. 2020 Oct;29(10):2097-2103. doi: 10.1016/j.jse.2020.03.008. Epub 2020 Jun 9. |
| 29752154 | Background | Page RS, Pai V, Eng K, Bain G, Graves S, Lorimer M. Cementless versus cemented glenoid components in conventional total shoulder joint arthroplasty: analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Shoulder Elbow Surg. 2018 Oct;27(10):1859-1865. doi: 10.1016/j.jse.2018.03.017. Epub 2018 May 8. |
| 24951741 | Background | Papadonikolakis A, Matsen FA 3rd. Metal-Backed Glenoid Components Have a Higher Rate of Failure and Fail by Different Modes in Comparison with All-Polyethylene Components: A Systematic Review. J Bone Joint Surg Am. 2014 Jun 18;96(12):1041-1047. doi: 10.2106/JBJS.M.00674. |
| 26227769 | Background | Boileau P, Moineau G, Morin-Salvo N, Avidor C, Godeneche A, Levigne C, Baba M, Walch G. Metal-backed glenoid implant with polyethylene insert is not a viable long-term therapeutic option. J Shoulder Elbow Surg. 2015 Oct;24(10):1534-43. doi: 10.1016/j.jse.2015.02.012. Epub 2015 Jul 27. |
| 32085766 | Background | Kim DM, Aldeghaither M, Alabdullatif F, Shin MJ, Kholinne E, Kim H, Jeon IH, Koh KH. Loosening and revision rates after total shoulder arthroplasty: a systematic review of cemented all-polyethylene glenoid and three modern designs of metal-backed glenoid. BMC Musculoskelet Disord. 2020 Feb 21;21(1):114. doi: 10.1186/s12891-020-3135-6. |
| 17015609 | Background | Bohsali KI, Wirth MA, Rockwood CA Jr. Complications of total shoulder arthroplasty. J Bone Joint Surg Am. 2006 Oct;88(10):2279-92. doi: 10.2106/JBJS.F.00125. No abstract available. |
| 21419661 | Background | Gonzalez JF, Alami GB, Baque F, Walch G, Boileau P. Complications of unconstrained shoulder prostheses. J Shoulder Elbow Surg. 2011 Jun;20(4):666-82. doi: 10.1016/j.jse.2010.11.017. Epub 2011 Mar 21. No abstract available. |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |