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

N/AEnrolling By InvitationNCT03806881

Materialise24 enrolled

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Arthroplasty, Replacement, Shoulder Glenoid Cavity Osteoarthritis of the Shoulder

Interventions

reversed glenoid prothesisDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

AZ St-Elisabeth

Herentals, Belgium

University Hospital Leuven - Traumatology

Leuven, Belgium

University Hospital Leuven - Orthopedics

Leuven, Belgium

Sint-Maartenskliniek

Nijmegen, Netherlands

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.