Poly vs Hybrid Glenoid in Stemless aTSA

NCT07520721 | Recruiting DMC

• 2 other identifiers: NL83282.018.232023.0616
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glenohumeral Osteoarthritis

Keywords

Osteoarthritis; Shoulder Joint; Arthroplasty, Replacement, Shoulder; Shoulder Prosthesis; Prostheses and Implants; Prosthesis Fixation; Prosthesis Failure; Prosthesis Loosening; Bone Cements; Polyethylene; Titanium; Osseointegration; Radiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Shoulder range of motion

  Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.

• Oxford Shoulder Score questionnaire

  Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.

• Hospital Anxiety subscale questionnaire

  Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.

• Hospital Depression subscale questionnaire

  Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.

• Subjective Shoulder Value Scale

  Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.

Other Outcomes (4)

• Number of implant-related complications

  From surgery through 10 years postoperatively.

• Number of non-implant-related complications

  From surgery through 10 years postoperatively.

• Number of implant-related adverse events

  From surgery through 10 years postoperatively.

Study Arms (2)

Standard cemented all-polyethylene pegged glenoid

ACTIVE COMPARATOR

Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid.

Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid

Hybrid trabecular titanium central-peg glenoid

EXPERIMENTAL

Hybrid trabecular titanium central-peg glenoid

Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid

Interventions

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).

Also known as: Cemented polyethylene glenoid component

Standard cemented all-polyethylene pegged glenoid

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.

Hybrid trabecular titanium central-peg glenoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Both genders;
• Age 18 years old;
• Life expectancy over 5 years;
• Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments;
• Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;
• 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.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;
• Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.

You may not qualify if:

• Patient requiring revision shoulder arthroplasty;
• Osteoporosis with a history of non-traumatic fractures;
• Steroid injections within the previous 6 months;
• Contralateral shoulder replacement within the previous 3 months;
• Meta-epiphyseal bony defect (including large cysts);
• Significant proven or suspicious infection of the target shoulder or any serious infectious disease
• Significant neurological or musculoskeletal disorders that may compromise functional recovery;
• Known or suspicious hypersensitivity to the metal or other materials of the implant;
• 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;
• Any systemic disease which may affect outcome.
• Active or metastatic neoplastic disease
• Chemotherapy and/or radiotherapy within the last 6 months
• Previous organ transplant
• Participation in any clinical research study that may interfere with this study
• A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder.

Sponsors & Collaborators

• Spaarne Gasthuis: lead
• Enovis: collaborator
• Isala: collaborator

Study Sites (1)

Spaarne Gasthuis

Hoofddorp, North Holland, 2134 TM, Netherlands

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Osteoarthritis; Prosthesis Failure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: April 9, 2026
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 30, 2035
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)