Glenohumeral OsteoarthritisPoly vs hybridNCT07520721
Poly vs Hybrid Glenoid in Stemless aTSA
A study testing Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid and Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid in people with Glenohumeral Osteoarthritis, run by Spaarne Gasthuis at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid and Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Jun 2025to Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM
Arthur van Noort, Md, PHD, +31 6 30693570, AvanNoort@spaarnegasthuis.nl
Artin Akchi Masjediy, Bsc, +31 6 42045899, Aakchimasjediy@spaarnegasthuis.nl
About this study
Official 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
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
- Being tested
- Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid, Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
- Keywords
- Osteoarthritis, Shoulder Joint, Arthroplasty, Replacement, Shoulder, Shoulder Prosthesis, Prostheses and Implants, Prosthesis Fixation, Prosthesis Failure, Prosthesis Loosening, Bone Cements, Polyethylene, Titanium, Osseointegration, Radiography
- Medical subject headings
- Osteoarthritis, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoidProcedure or surgery
Also called Cemented polyethylene glenoid component
Stemless 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 glenoidProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard cemented all-polyethylene pegged glenoid | Active comparator | Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid. Receives: Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid |
| Hybrid trabecular titanium central-peg glenoid | Experimental | Hybrid trabecular titanium central-peg glenoid Receives: Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Jun 2025
- Primary completion30 Jul 2035 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Isala, Enovis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520721
- Sponsor's protocol ID
- NL83282.018.23
- Other IDs
- 2023.0616
- Acronym
- Poly vs hybrid
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD will not be shared because the protocol does not include an IPD-sharing plan and participant data are handled as coded personal data under GDPR/AVG with access restricted to authorized study personnel; any data transfer is limited to protocol-defined purposes (e.g., publication support).
Publications
Sheikhzadeh A, Wertli MM, Weiner SS, Rasmussen-Barr E, Weiser S. Do psychological factors affect outcomes in musculoskeletal shoulder disorders? A systematic review. BMC Musculoskelet Disord. 2021 Jun 19;22(1):560. doi: 10.1186/s12891-021-04359-6.
PubMed 34147071Lazarus MD, Jensen KL, Southworth C, Matsen FA 3rd. The radiographic evaluation of keeled and pegged glenoid component insertion. J Bone Joint Surg Am. 2002 Jul;84(7):1174-82. doi: 10.2106/00004623-200207000-00013.
PubMed 12107318Youderian AR, Ricchetti ET, Drews M, Iannotti JP. Determination of humeral head size in anatomic shoulder replacement for glenohumeral osteoarthritis. J Shoulder Elbow Surg. 2014 Jul;23(7):955-63. doi: 10.1016/j.jse.2013.09.005. Epub 2013 Dec 8.
PubMed 24321169Beck S, Martin RJ, Patsalis T, Burggraf M, Busch A, Landgraeber S, Alexander W. Determination of humeral inclination in stemless shoulder arthroplasty using plain radiographs. Orthop Rev (Pavia). 2019 Dec 2;11(4):8194. doi: 10.4081/or.2019.8194. eCollection 2019 Dec 2.
PubMed 31897278Werthel JD, Boux de Casson F, Burdin V, Athwal GS, Favard L, Chaoui J, Walch G. CT-based volumetric assessment of rotator cuff muscle in shoulder arthroplasty preoperative planning. Bone Jt Open. 2021 Jul;2(7):552-561. doi: 10.1302/2633-1462.27.BJO-2021-0081.R1.
PubMed 34315280Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016 Oct;25(10):1601-6. doi: 10.1016/j.jse.2016.03.010. Epub 2016 Jun 6.
PubMed 27282738Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.
PubMed 10512449Levin JM, Rodriguez K, Polascik BA, Zeng S, Warren E Jr, Rechenmacher A, Helmkamp J, Goltz DE, Wickman J, Klifto CS, Lassiter TE, Anakwenze O. Simple preoperative radiographic and computed tomography measurements predict adequate bone quality for stemless total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Dec;31(12):2481-2487. doi: 10.1016/j.jse.2022.05.008. Epub 2022 Jun 4.
PubMed 35671925Sluiter JK, Frings-Dresen MH. Quality of life and illness perception in working and sick-listed chronic RSI patients. Int Arch Occup Environ Health. 2008 Feb;81(4):495-501. doi: 10.1007/s00420-007-0222-z. Epub 2007 Jul 19.
PubMed 17638005El Fassi M, Bocquet V, Majery N, Lair ML, Couffignal S, Mairiaux P. Work ability assessment in a worker population: comparison and determinants of Work Ability Index and Work Ability score. BMC Public Health. 2013 Apr 8;13:305. doi: 10.1186/1471-2458-13-305.
PubMed 23565883Ilmarinen J, Tuomi K. Work ability of aging workers. Scand J Work Environ Health. 1992;18 Suppl 2:8-10. No abstract available.
PubMed 1514096Aerts BR, Kuijer PP, Beumer A, Eygendaal D, Frings-Dresen MH. WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP): Factor Analysis and Internal Consistency. Arch Phys Med Rehabil. 2018 Sep;99(9):1818-1826. doi: 10.1016/j.apmr.2018.03.013. Epub 2018 Apr 17.
PubMed 29678451Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000 Mar;82(3):304-14. doi: 10.2106/00004623-200003000-00002.
PubMed 10724223
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07520721
- Acronym / sponsor ID
- Poly vs hybrid / NL83282.018.23
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- Osteoarthritis, Shoulder Joint, Arthroplasty, Replacement, Shoulder, Shoulder Prosthesis, Prostheses and Implants, Prosthesis Fixation, Prosthesis Failure, Prosthesis Loosening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Collaborators
- Isala, Enovis
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jul 2035 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cemented all-polyethylene pegged glenoid | Active comparator | Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoidAnatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid. |
| Hybrid trabecular titanium central-peg glenoid | Experimental | Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoidHybrid trabecular titanium central-peg glenoid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -
- 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;
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoidAlso: Cemented polyethylene glenoid componentStemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept). | Procedure or surgery | Standard cemented all-polyethylene pegged glenoid |
| Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoidStemless anatomic total shoulder arthroplasty (SMR system) with a hybrid polyethylene glenoid: porous trabecular titanium central peg intended for bone ingrowth plus cemented peripheral pegs. | Procedure or surgery | Hybrid trabecular titanium central-peg glenoid |
Primary outcome
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.
10 secondary outcomes
Shoulder range of motion
Time frame: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Oxford Shoulder Score questionnaire
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Hospital Anxiety subscale questionnaire
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Hospital Depression subscale questionnaire
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Subjective Shoulder Value Scale
Time frame: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.
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 - EuroQol-5D Visual Analogue Scal
Time frame: Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.
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 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.
Implant survival (radiographic loosening endpoint)
Time frame: Up to 10 years postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 34147071Sheikhzadeh A, Wertli MM, Weiner SS, Rasmussen-Barr E, Weiser S. Do psychological factors affect outcomes in musculoskeletal shoulder disorders? A systematic review. BMC Musculoskelet Disord. 2021 Jun 19;22(1):560. doi: 10.1186/s12891-021-04359-6.
- Background: PubMed 12107318Lazarus MD, Jensen KL, Southworth C, Matsen FA 3rd. The radiographic evaluation of keeled and pegged glenoid component insertion. J Bone Joint Surg Am. 2002 Jul;84(7):1174-82. doi: 10.2106/00004623-200207000-00013.
- Background: PubMed 24321169Youderian AR, Ricchetti ET, Drews M, Iannotti JP. Determination of humeral head size in anatomic shoulder replacement for glenohumeral osteoarthritis. J Shoulder Elbow Surg. 2014 Jul;23(7):955-63. doi: 10.1016/j.jse.2013.09.005. Epub 2013 Dec 8.
- Background: PubMed 31897278Beck S, Martin RJ, Patsalis T, Burggraf M, Busch A, Landgraeber S, Alexander W. Determination of humeral inclination in stemless shoulder arthroplasty using plain radiographs. Orthop Rev (Pavia). 2019 Dec 2;11(4):8194. doi: 10.4081/or.2019.8194. eCollection 2019 Dec 2.
- Background: PubMed 34315280Werthel JD, Boux de Casson F, Burdin V, Athwal GS, Favard L, Chaoui J, Walch G. CT-based volumetric assessment of rotator cuff muscle in shoulder arthroplasty preoperative planning. Bone Jt Open. 2021 Jul;2(7):552-561. doi: 10.1302/2633-1462.27.BJO-2021-0081.R1.
- Background: PubMed 27282738Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016 Oct;25(10):1601-6. doi: 10.1016/j.jse.2016.03.010. Epub 2016 Jun 6.
- Background: PubMed 10512449Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.
- Background: PubMed 35671925Levin JM, Rodriguez K, Polascik BA, Zeng S, Warren E Jr, Rechenmacher A, Helmkamp J, Goltz DE, Wickman J, Klifto CS, Lassiter TE, Anakwenze O. Simple preoperative radiographic and computed tomography measurements predict adequate bone quality for stemless total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Dec;31(12):2481-2487. doi: 10.1016/j.jse.2022.05.008. Epub 2022 Jun 4.
- Background: PubMed 17638005Sluiter JK, Frings-Dresen MH. Quality of life and illness perception in working and sick-listed chronic RSI patients. Int Arch Occup Environ Health. 2008 Feb;81(4):495-501. doi: 10.1007/s00420-007-0222-z. Epub 2007 Jul 19.
- Background: PubMed 23565883El Fassi M, Bocquet V, Majery N, Lair ML, Couffignal S, Mairiaux P. Work ability assessment in a worker population: comparison and determinants of Work Ability Index and Work Ability score. BMC Public Health. 2013 Apr 8;13:305. doi: 10.1186/1471-2458-13-305.
- Background: PubMed 1514096Ilmarinen J, Tuomi K. Work ability of aging workers. Scand J Work Environ Health. 1992;18 Suppl 2:8-10. No abstract available.
- Background: PubMed 29678451Aerts BR, Kuijer PP, Beumer A, Eygendaal D, Frings-Dresen MH. WOrk-Related Questionnaire for UPper extremity disorders (WORQ-UP): Factor Analysis and Internal Consistency. Arch Phys Med Rehabil. 2018 Sep;99(9):1818-1826. doi: 10.1016/j.apmr.2018.03.013. Epub 2018 Apr 17.
- Individual participant dataSharing planned: No. De-identified IPD will not be shared because the protocol does not include an IPD-sharing plan and participant data are handled as coded personal data under GDPR/AVG with access restricted to authorized study personnel; any data transfer is limited to protocol-defined purposes (e.g., publication support).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid and Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid in people with Glenohumeral Osteoarthritis, run by Spaarne Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (shoulder function) (time frame: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07520721, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.