ClinicalTrials.gg
Active, not recruitingNCT03806881Updated Oct 8, 2026

Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant

An observational study in Arthroplasty, Replacement, Shoulder, Glenoid Cavity and Osteoarthritis of the Shoulder, sponsored by Materialise. Active, not recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Materialise · Observational

Updated Oct 8, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 53 studies in Osteoarthritis with a site in Belgium — 5 open to participants now, 13 under way, 1 of them phase 3. Osteoarthritis · Belgium.

Planned enrollment
15th of 15
24 · median 154
Started
2019
with 1 other
Observational
15 of 53
1 open now
Primary completion
2030-03
later than 8 of 12 live
Registered
41st of 53
by date

Among the 53 studies in Osteoarthritis with a site in Belgium, this one is the 15th largest by planned enrollment of the 15 observational ones that give a count, is one of 2 that started in 2019, is one of 15 observational ones, reaches primary completion later than 8 of the 12 other live ones, and was the 41st registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 437 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

5 of the 53 studies in Osteoarthritis with a site in Belgium are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 286 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Arthroplasty, Replacement, Shoulder
  • Glenoid Cavity
  • Osteoarthritis of the Shoulder

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 process and has signed the EC approved informed consent form

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients
  • Skeletally immature patients
  • Prisoners
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • Treatment group

    Patients treated with a Glenius Glenoid Reconstruction System

    Device: reversed glenoid prothesis

Interventions

  • Devicereversed glenoid prothesis

    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.

    Also known as: Glenius Glenoid Reconstruction system

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

Secondary outcomes

  1. 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).

    Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

  2. 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).

    Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

  3. 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).

    Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

  4. 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).

    Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery

  5. 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.

    Time frame: 6 weeks after surgery

  6. 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.

    Time frame: 6 weeks after surgery

  7. 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.

    Time frame: 1 year after surgery

  8. 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.

    Time frame: 1 year after surgery

  9. 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)

    Time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery

  10. 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)

    Time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery

  11. 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)

    Time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery

  12. 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.

    Time frame: up to 5 years after surgery

  13. 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.

    Time frame: up to 5 year after surgery

07

Study locations

4 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2019 (actual). Primary completion is estimated for Mar 2030, 128 months after the start.

Of 82 industry-sponsored observational studies under Osteoarthritis, half reached primary completion within 93 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 184. This study's planned 128 months is above that.

Counting every sponsor, half of 228 studies reached it within 57 months; a quarter within 21 and three quarters within 141.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Oct 2024 → Mar 2030 and completion Dec 2028 → Mar 2030.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2019
First posted
Jan 16, 2019
StartActual
Jul 1, 2019
Primary completionEst.
Mar 2030was Oct 2024
CompletionEst.
Mar 2030was Dec 2028
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Active, not recruiting
changed Oct 8, 2026
Primary completion
Oct 1, 2024→Mar 2030
Oct 8, 2026
Study completion
Dec 1, 2028→Mar 2030
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Enrolling by invitation→Active, not recruiting
    Primary completion Oct 1, 2024→Mar 2030
    Study completion Dec 1, 2028→Mar 2030
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03806881
Lead sponsor
Materialise
Responsible party
Sponsor
First posted
Jan 16, 2019
Start date
Jul 1, 2019
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Oct 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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