Arthroplasty, Replacement, ShoulderNCT03806881
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
An observational study of Arthroplasty, Replacement, Shoulder and Glenoid Cavity, run by Materialise at 4 sites in 2 countries.
Trial summary
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder, Glenoid Cavity, Osteoarthritis of the Shoulder
- What is being tested?
- reversed glenoid prothesis
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jul 2019to Mar 2030
- Phase
- Observational
- 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
Study population: The study population consists of patients having primary or revision shoulder joint replacement with severe glenoid bone defects caused by:(1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, (2) Inflammatory degenerative joint disease such as rheumatoid arthritis or (3) Congenital malformations, posttraumatic deformities or removal of components during revision surgery
Who may be able to join
- patients having primary or revision shoulder joint replacement with severe glenoid bone defects
- Patient is 18 years of age or older
- Patient can follow the Glenius system procedure that is standard of care
- Patient is willing to cooperate in the required post-operative therapy
- Patient has participated in the informed consent process and has signed the EC approved informed consent form
Who cannot join
- Pregnant patients
- Skeletally immature patients
- Prisoners
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
AZ St-Elisabeth
Herentals
University Hospital Leuven - Traumatology
Leuven, 3000
University Hospital Leuven - Orthopedics
Leuven
About this study
Official title: Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system
Read the detailed description
The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these cases, standard reconstruction of the glenoid is not possible because of the lack of body support of the glenoid rim or columns.
The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is designed based on a detailed 3D CT analysis of the defect with special reference to bone quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories are defined for each individual patient, which accommodate screws that are positioned and angled towards the best bone stock available in the glenoid/coracoid/scapula with each specific patient. The surgeon provides feedback on the the design and orientation of the implant needed to achieve the optimal inclination of the head and the position \& offset of the joint's centre of rotation.
Because Glenius is a relatively new product and only for use in specific and complex cases of severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce. With this study we aim to collect long-term clinical and radiological follow-up data for patients treated with Glenius in a uniform, standardized way.
- Being tested
- reversed glenoid prothesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reversed glenoid prothesisDevice
Also called Glenius Glenoid Reconstruction system
All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Patients treated with a Glenius Glenoid Reconstruction System Receives: Device: reversed glenoid prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Constant-Murley Score after surgery
The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).
Measured: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Secondary outcomes (13)
Change in baseline Simple Shoulder Test (SST) after surgery
The SST is a function scale with 12 items, used to assess improvement in shoulder function after treatment interventions and to check the patient's ability to tolerate or perform 12 activities of daily living. The scores range from 0 (worst functional outcome) to 100 (best functional outcome).
Measured: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Change in baseline Oxford Shoulder Score (OSS) after surgery
The OSS is a 12-item patient-reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. The score ranges from 0 (no pain or functional impairement) to 60 (worst pain and functional impairement).
Measured: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
change in general health EQ5D score after surgery
EQ-5D is a standardized patient-reported outcome for measuring generic health status. The questionnaire has two components: a health state description measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. and a general evaluation of their overall health status using the visual analogue scale (EQ-VAS).
Measured: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
change in baseline pain score using Visual Analogue Scales (VAS) after surgery
The VAS pain score is a patient-reported evaluation of pain intensity on a Visual Analogue Scales (VAS) between 0 (no pain) and 100 (worst pain imaginable).
Measured: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Translational deviation from planned implant position
translational deviation (in mm) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.
Measured: 6 weeks after surgery
Rotational deviation from planned implant position
Rotational deviation (in degrees) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.
Measured: 6 weeks after surgery
Translational deviation from initial implant position
translational deviation (in mm) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.
Measured: 1 year after surgery
Rotational deviation from initial implant position
Rotational deviation (in degrees) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.
Measured: 1 year after surgery
Scapular notching
scapular notching will be graded according to the Sirveaux classification system (2004) on a shoulder radiograph. The classification goes from 0 (no notching) to 4 (erosion over the inferior screw with extension under the baseplate)
Measured: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
Radiolucensies
Radiolucencies surrounding the glenoid component will be graded according to the system of Lazarus (Lazarus et al 2002) on a shoulder radiograph. The classification goes from 0 (no lucensies) to 5 (gross lucensies and radiographic loosening)
Measured: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
Heterotopic ossifications
periarticular heterotopic ossification (HO) will be scored according to a modified Brooker classification system of HO of the hip (Verhofste et al 2016) on a shoulder radiograph. The classification goes from 0 (no ossifications) to 3 (complete ankylosis of the shoulder)
Measured: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
rate of implant revision surgeries up to 5 years after surgery
Implant survival will be calculated by calculating the rate of implant revision surgeries up to 5 years after surgery.
Measured: up to 5 years after surgery
Complication rate
the number and kind of (severe) adverse (device) events: device/shoulder related A(D)Es, SA(D)Es and device deficiencies that could have led to an SAE will be collected.
Measured: up to 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Jul 2019
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, ShoulderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materialise
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806881
- Sponsor's protocol ID
- SMAT009
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03806881
- Acronym / sponsor ID
- SMAT009
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- MaterialiseIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 Jan 2019 (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.
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system
Detailed description
The Glenius glenoid implant is a solution for patients who need a reversed glenoid reconstruction (primary or revision) because of a severely damaged glenoid associated with severe bone loss. In these cases, standard reconstruction of the glenoid is not possible because of the lack of body support of the glenoid rim or columns.
The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is designed based on a detailed 3D CT analysis of the defect with special reference to bone quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories are defined for each individual patient, which accommodate screws that are positioned and angled towards the best bone stock available in the glenoid/coracoid/scapula with each specific patient. The surgeon provides feedback on the the design and orientation of the implant needed to achieve the optimal inclination of the head and the position \& offset of the joint's centre of rotation.
Because Glenius is a relatively new product and only for use in specific and complex cases of severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce. With this study we aim to collect long-term clinical and radiological follow-up data for patients treated with Glenius in a uniform, standardized way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Device: reversed glenoid prothesisPatients treated with a Glenius Glenoid Reconstruction System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients having primary or revision shoulder joint replacement with severe glenoid bone defects caused by:(1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, (2) Inflammatory degenerative joint disease such as rheumatoid arthritis or (3) Congenital malformations, posttraumatic deformities or removal of components during revision surgery
Key inclusion criteria (5 listed)
- patients having primary or revision shoulder joint replacement with severe glenoid bone defects
- Patient is 18 years of age or older
- Patient can follow the Glenius system procedure that is standard of care
- Patient is willing to cooperate in the required post-operative therapy
- Patient has participated in the informed consent process and has signed the EC approved informed consent form
Key exclusion criteria (3 listed)
- Pregnant patients
- Skeletally immature patients
- Prisoners
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 |
|---|---|---|
| reversed glenoid prothesisAlso: Glenius Glenoid Reconstruction systemAll patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered. | Device | Treatment group |
Primary outcome
Change in baseline Constant-Murley Score after surgery
Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).
13 secondary outcomes
Change in baseline Simple Shoulder Test (SST) after surgery
Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Change in baseline Oxford Shoulder Score (OSS) after surgery
Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
change in general health EQ5D score after surgery
Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
change in baseline pain score using Visual Analogue Scales (VAS) after surgery
Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Translational deviation from planned implant position
Time frame: 6 weeks after surgery
Rotational deviation from planned implant position
Time frame: 6 weeks after surgery
Translational deviation from initial implant position
Time frame: 1 year after surgery
Rotational deviation from initial implant position
Time frame: 1 year after surgery
Scapular notching
Time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
Radiolucensies
Time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
Heterotopic ossifications
Time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
rate of implant revision surgeries up to 5 years after surgery
Time frame: up to 5 years after surgery
Complication rate
Time frame: up to 5 year after surgery
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Shoulder and Glenoid Cavity, run by Materialise at 4 sites in 2 countries.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline Constant-Murley Score after surgery (time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.