RecruitingNot Applicable

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

France1,004 participantsStarted 2020-06-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Revision rate (KM) at 10 years postoperative

Timeframe: at the end of the postoperative follow-up period of 10 years

Trial details

NCT IDNCT07558590

SponsorFX Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2036-12-31

Contact for this trial

Kathy TRIER, PhD

800-280-0775 ktrier@fxshouldersolutions.com