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NCT Number: NCT07520721

Poly vs Hybrid Glenoid in Stemless aTSA

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.

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Key information

Conditions

Glenohumeral Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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;
  • 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);
  • 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.

Exclusion criteria

  • 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.
  • Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or severe alcohol use disorder.
  • Imminent suicide risk.
  • Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment

Treatment and study plan

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).

Other names: Cemented polyethylene glenoid component

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.

Primary outcomes

  1. Constant-Murley Score (shoulder function)

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

    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.

Secondary outcomes

  1. Shoulder range of motion

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

    Active shoulder range of motion (e.g., forward flexion, abduction, external/internal rotation) assessed clinically to compare recovery between glenoid groups.

  2. Oxford Shoulder Score questionnaire

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

    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.

  3. Hospital Anxiety subscale questionnaire

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

    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.

  4. Hospital Depression subscale questionnaire

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

    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.

  5. Subjective Shoulder Value Scale

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

    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.

  6. Health-related quality of life - EuroQol-5D descriptive system

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

    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.

  7. Health-related quality of life - EuroQol-5D Visual Analogue Scal

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

    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.

  8. Work-Related Questionnaire for Upper Extremity Disorders

    Time frame: Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.

    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.

  9. Work Ability (single-item Work Ability Score) numeric scale

    Time frame: Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.

    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.

  10. Implant survival (radiographic loosening endpoint)

    Time frame: Up to 10 years postoperatively.

    Time-to-event implant survival where failure is defined as radiographic loosening and/or revision as specified in the protocol; compared between arms.

Other outcomes

  1. Number of implant-related complications

    Time frame: From surgery through 10 years postoperatively.

    Number of implant-related complications recorded from surgery through 10 years postoperatively.

  2. Number of non-implant-related complications

    Time frame: From surgery through 10 years postoperatively.

    Number of non-implant-related complications recorded from surgery through 10 years postoperatively.

  3. Number of implant-related adverse events

    Time frame: From surgery through 10 years postoperatively.

    Number of implant-related adverse events recorded from surgery through 10 years postoperatively.

  4. Number of non-implant-related adverse events

    Time frame: From surgery through 10 years postoperatively.

    Number of non-implant-related adverse events recorded from surgery through 10 years postoperatively.

Sponsors and collaborators

Lead sponsor

Spaarne Gasthuis

Other

Collaborators

  • Enovis
  • Isala

Registry information

Official study title

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

Acronym: Poly vs hybrid

Important dates

Study start
2025
Primary completion
2035
Study completion
2036
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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