Clinical Trials Logo
  1. Home
  2. Osteoarthritis of the Shoulder
  3. NCT04468178

Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

Osteoarthritis of the Shoulder Clinical Trial

Official title:
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

Clinical Trial Summary

The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

Clinical Trial Description

The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical). As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination. Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation. The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04468178
Study type Interventional
Source Hannover Medical School
Contact Tomas Smith, PD Dr.
Phone +49 511 5354 310
Email tomas.smith@diakovere.de
Status Recruiting
Phase N/A
Start date September 17, 2021
Completion date December 31, 2027
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05160441 - Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis Phase 3
Suspended NCT02204228 - TITAN™ Reverse Shoulder System
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
Enrolling by invitation NCT03806881 - Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
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