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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
94
Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).
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.
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
RECRUITINGConstant-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.
Time frame: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.
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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Hospital Depression subscale questionnaire
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 years postoperatively.