Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: reversed glenoid prothesis.
- Who it may be relevant to
- Registry conditions: Arthroplasty, Replacement, Shoulder, Glenoid Cavity, Osteoarthritis of the Shoulder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study
Overview
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.
Interventions
- Device reversed 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.
Primary outcome measures
- Change in baseline Constant-Murley Score after surgery [Time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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 informed consent process and has signed the EC approved informed consent form
Exclusion criteria
- Pregnant patients
- Skeletally immature patients
- Prisoners
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 3 centers
- AZ St-Elisabeth — Herentals
- University Hospital Leuven - Traumatology — Leuven
- University Hospital Leuven - Orthopedics — Leuven
Netherlands · 1 center
- Sint-Maartenskliniek — Nijmegen
Identifiers
NCT: NCT03806881 · SMAT009