Glenohumeral Osteoarthritis
Conditions
Keywords
Osteoarthritis, Shoulder Joint, Arthroplasty, Replacement, Shoulder, Shoulder Prosthesis, Prostheses and Implants, Prosthesis Fixation, Prosthesis Failure, Prosthesis Loosening, Bone Cements, Polyethylene, Titanium, Osseointegration, Radiography
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.
Interventions
PROCEDUREAnatomic 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).
PROCEDUREAnatomic 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.
Sponsors
Spaarne Gasthuis
Isala
Enovis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant-Murley Score (shoulder function) | 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
| Measure | Time frame | Description |
|---|---|---|
| Shoulder range of motion | 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. |
| Oxford Shoulder Score questionnaire | 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. |
| Hospital Anxiety subscale questionnaire | 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. |
| Hospital Depression subscale questionnaire | 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. |
| Subjective Shoulder Value Scale | 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. |
| Health-related quality of life - EuroQol-5D descriptive system | 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. |
| Health-related quality of life - EuroQol-5D Visual Analogue Scal | 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. |
| Work-Related Questionnaire for Upper Extremity Disorders | 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. |
| Work Ability (single-item Work Ability Score) numeric scale | 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. |
| Implant survival (radiographic loosening endpoint) | 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. |
Countries
Netherlands
Outcome results
None listed