Clinical Trials Logo
  1. Home
  2. Osteoarthritis of the Shoulder
  3. NCT03806881

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

Osteoarthritis of the Shoulder Clinical Trial

Official title:
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study

Clinical 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03806881
Study type Observational
Source Materialise
Contact
Status Enrolling by invitation
Phase
Start date July 1, 2019
Completion date December 1, 2028
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05160441 - Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis Phase 3
Active, not recruiting NCT02204228 - TITAN™ Reverse Shoulder System
Recruiting NCT04468178 - Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder N/A
Withdrawn NCT03770546 - Amnion-Based Injections in the Shoulder N/A
Active, not recruiting NCT05049993 - Pyrocarbon Clinical Follow-up Study
Terminated NCT04160091 - Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis Phase 2
Completed NCT00479687 - SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder N/A
Recruiting NCT04228419 - TSA vs RSA in Glenohumeral Osteoarthritis N/A
Enrolling by invitation NCT03404778 - Comprehensive Reverse Shoulder Data Collection
Completed NCT02052206 - Reconstruction of Complex Proximal Humeral Fractures. N/A
Completed NCT03887650 - LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs Phase 4
Active, not recruiting NCT04634773 - Unravelling the Etiology of Shoulder Osteoarthritis N/A
Completed NCT01697865 - Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction N/A
Active, not recruiting NCT01587560 - A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant N/A
Completed NCT03385408 - Effectiveness of HILT in Shoulder Osteoarthritis N/A
Active, not recruiting NCT03097406 - Functional Outcome and Complications After Global Unite ® Prostheses
Active, not recruiting NCT03409718 - Database Retrieval for the Comprehensive Shoulder
Withdrawn NCT04134442 - Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome Phase 4
Completed NCT03382262 - Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip Phase 2
Active, not recruiting NCT03726554 - Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty N/A