Poly vs Hybrid Glenoid in Stemless aTSA
ConditionGlenohumeral Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpaarne Gasthuis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid
Procedure/SurgeryStemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).
Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
Procedure/SurgeryStemless anatomic total shoulder arthroplasty (SMR system) with a hybrid polyethylene glenoid: porous trabecular titanium central peg intended for bone ingrowth plus cemented peripheral pegs.
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Standard cemented all-polyethylene pegged glenoidActive comparator 1 intervention
Group B: Hybrid trabecular titanium central-peg glenoidExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.Secondary outcomes
1
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.2
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.3
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.4
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.
Time frame
Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.Other outcomes
1
Number of implant-related complications
Number of implant-related complications recorded from surgery through 10 years postoperatively.
Time frame
From surgery through 10 years postoperatively.2
Number of non-implant-related complications
Number of non-implant-related complications recorded from surgery through 10 years postoperatively.
Time frame
From surgery through 10 years postoperatively.3
Number of implant-related adverse events
Number of implant-related adverse events recorded from surgery through 10 years postoperatively.
Time frame
From surgery through 10 years postoperatively.4
Number of non-implant-related adverse events
Number of non-implant-related adverse events recorded from surgery through 10 years postoperatively.
Time frame
From surgery through 10 years postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov