RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
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: Shoulder arthroplasty.
- Who it may be relevant to
- Registry conditions: Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear. Basic parameters: from 18 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
- France, Monaco
- 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
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term. Secondary objectives are * Revision rate at each post op visit * Range of motion at each post op visit * Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit * Radiological assessment of implant positioning through geometrical parameters at each post op visit * Incidence of complications at each post op visit * Qualitative feedback from surgeons on the instrumentation
Detailed description
1004 cases are planned to be included in 11 groups of implants (range, indication and constructs).
Recruitment of patients can be retrospective or prospective, preferrably prospective.
Prospective follow-up of the patients after inclusion at 6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years , 7 years and 10 years postoperatively.
Interventions
- Procedure Shoulder arthroplasty
Total anatomical (TSA), hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Primary outcome measures
- Revision rate (KM) at 10 years postoperative [Time frame: at the end of the postoperative follow-up period of 10 years]
Secondary outcome measures (10)
- Revision rate (KM) at each post-operative visits [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years)]
- Range of Motions at each postoperative visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- QuickDASH score at each follow-up visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Constant-Murley score at each follow-up visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- ASES score at each postoperative visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- VAS pain at each postoperative visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- SSV score at each postoperative visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Radiological assessment of implant positioning at each postoperative visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Incidence of complications at each postoperative visit [Time frame: At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)]
- Qualitative feedback on the instrumentation [Time frame: at surgery reporting]
Eligibility criteria
Inclusion criteria
- Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.
- Patient aged 18 years and above
- Patient insured with a social security system
- Has been informed and did consent to participate to the study.
Exclusion criteria
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 21 centers
- CHU Amiens Picardie — Amiens
- CHU d' Angers — Angers
- Hôpital Jean Minjoz — Besançon
- Clinique Aguiléra — Biarritz
- Hôpital privé Saint-Martin — Caen
- Infirmerie Protestante — Caluire-et-Cuire
- CHMS Chambéry — Chambéry
- HÔPITAUX CIVILS de Colmar — Colmar
- … and 13 more centers
Monaco · 1 center
- Centre Hospitalier Princesse Grace — Monaco
Identifiers
NCT: NCT07558590 · FX_PROTOC_CL_19-03 · 2019-A01279-48