Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
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: Total joint arthroplasty of the glenohumeral joint.
- Who it may be relevant to
- Registry conditions: Osteoarthritis of the Shoulder. Basic parameters: 18 years — 80 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
- Germany
- 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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Overview
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).
Detailed 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.
Interventions
- Device Total joint arthroplasty of the glenohumeral joint
The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.
Primary outcome measures
- Constant-Murley Score (CMS) [Time frame: 3 months postoperative]
- Constant-Murley Score (CMS) [Time frame: 12 months postoperative]
- Constant-Murley Score (CMS) [Time frame: 24 months postoperative]
Secondary outcome measures (6)
- Oxford Shoulder Score (OSS) [Time frame: 3 months postoperative]
- Oxford Shoulder Score (OSS) [Time frame: 12 months postoperative]
- Oxford Shoulder Score (OSS) [Time frame: 24 months postoperative]
- Short Form Health 36 (SF-36) [Time frame: 3 months postoperative]
- Short Form Health 36 (SF-36) [Time frame: 12 months postoperative]
- Short Form Health 36 (SF-36) [Time frame: 24 months postoperative]
Eligibility criteria
Inclusion criteria
- Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
- Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
- Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
- Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
- Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).
Exclusion criteria
- Previous operation on the rotator cuff of the affected shoulder
- Dysfunctional rotator cuff
- Infection of the affected shoulder joint or systemic infection
- Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift — Hanover
Identifiers
NCT: NCT04468178 · IIT-RSA-Global-Icon-2020