Clinical trial NCT03806881: Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Official title: Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Arthroplasty, Replacement, Shoulder
Glenoid Cavity
Osteoarthritis of the Shoulder
Lead sponsor: Materialise
Sponsor class: INDUSTRY
First posted: 2019-01-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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.

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

Primary outcomes:
measure: Change in baseline Constant-Murley Score after surgery
timeFrame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
Secondary outcomes:
measure: Change in baseline Simple Shoulder Test (SST) after surgery
timeFrame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
measure: Change in baseline Oxford Shoulder Score (OSS) after surgery
timeFrame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
measure: change in general health EQ5D score after surgery
timeFrame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
measure: change in baseline pain score using Visual Analogue Scales (VAS) after surgery
timeFrame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
measure: Translational deviation from planned implant position
timeFrame: 6 weeks after surgery
measure: Rotational deviation from planned implant position
timeFrame: 6 weeks after surgery
measure: Translational deviation from initial implant position
timeFrame: 1 year after surgery
measure: Rotational deviation from initial implant position
timeFrame: 1 year after surgery
measure: Scapular notching
timeFrame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
measure: Radiolucensies
timeFrame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
measure: Heterotopic ossifications
timeFrame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
measure: rate of implant revision surgeries up to 5 years after surgery
timeFrame: up to 5 years after surgery
measure: Complication rate
timeFrame: up to 5 year after surgery
Other outcomes:
Locations:
city: Herentals
country: Belgium
facility: AZ St-Elisabeth
city: Leuven
country: Belgium
facility: University Hospital Leuven - Traumatology
city: Leuven
country: Belgium
facility: University Hospital Leuven - Orthopedics
city: Nijmegen
country: Netherlands
facility: Sint-Maartenskliniek
Study officials:
References: