Poly vs Hybrid Glenoid in Stemless aTSA (Poly vs hybrid)

A Randomised, Multicentre, Prospective, Non-inferiority Clinical Study Analysing Outcomes of a Cemented Pegged Polyethylene Glenoid Component Versus a Hybrid Polyethylene and Trabecular Titanium Glenoid Component in Patients With Osteoarthritis Treated With an Anatomical SMR Stemless Shoulder Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Glenohumeral Osteoarthritis
• Intervention / Treatment: Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid; Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Hoofddorp, North Holland, Netherlands, 2134 TM
      • Recruiting
      • Spaarne Gasthuis
      • Contact: Arthur van Noort, Md, PHD; Phone Number: +31 6 30693570; Email: AvanNoort@spaarnegasthuis.nl
      • Contact: Artin Akchi Masjediy, Bsc; Phone Number: +31 6 42045899; Email: Aakchimasjediy@spaarnegasthuis.nl
      • Principal Investigator: Arthur van Noort, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Both genders;
2. Age 18 years old;
3. Life expectancy over 5 years;
4. Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments;
5. Patient is requiring primary unilateral or staged bilateral anatomic arthroplasty based on physical examination, medical history and X ray examination. (In cases where bilateral aTSA's are indicated, the patient will be included for the second aTSA again when the patient meets the inclusion criteria);
6. Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;
7. A diagnosis in the target shoulder of osteoarthritis; according to the classification of Walch, the glenoid should be a type A1, A2 or B1. Retroversion should not exceed 15 degrees.
8. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;
9. Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.

Exclusion Criteria:

1. Patient requiring revision shoulder arthroplasty;
2. Osteoporosis with a history of non-traumatic fractures;
3. Steroid injections within the previous 6 months;
4. Contralateral shoulder replacement within the previous 3 months;
5. Meta-epiphyseal bony defect (including large cysts);
6. Significant proven or suspicious infection of the target shoulder or any serious infectious disease
7. Significant neurological or musculoskeletal disorders that may compromise functional recovery;
8. Known or suspicious hypersensitivity to the metal or other materials of the implant;
9. Unwillingness or inability (i.e. alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
10. Any systemic disease which may affect outcome.
11. Active or metastatic neoplastic disease
12. Chemotherapy and/or radiotherapy within the last 6 months
13. Previous organ transplant
14. Participation in any clinical research study that may interfere with this study
15. A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder.
16. Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or severe alcohol use disorder.
17. Imminent suicide risk.
18. Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard cemented all-polyethylene pegged glenoid; Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid.	Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid; Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).; Other Names: Cemented polyethylene glenoid component
Experimental: Hybrid trabecular titanium central-peg glenoid	Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Spaarne Gasthuis
• Collaborators: Isala; Enovis

Publications and helpful links

General Publications

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• 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.
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• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
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• 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.
• 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.
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• 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.
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Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): July 30, 2035
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Osseointegration; Titanium; Arthroplasty, Replacement, Shoulder; Prostheses and Implants; Shoulder Joint; Radiography; Polyethylene; Bone Cements; Prosthesis Failure; Shoulder Prosthesis; Prosthesis Fixation; Prosthesis Loosening
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Prosthesis Failure
• Other Study ID Numbers: NL83282.018.23; 2023.0616 (Other Identifier: METC Amsterdam UMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No