RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
Key facts
- Who runs it
- FX Solutions
- Where
- Amiens, Angers, Besançon, Biarritz, Caen, Caluire-et-Cuire, Chambéry, Colmar, Dijon, La Roche-sur-Yon, Les Sables-d'Olonne, Lyon, Nantes, Paris, Pessac, Quimper, Saint-Etienne, Saint-Herblain, Saint-Nazaire, and Strasbourg, FranceSee the 21 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Recruiting
- People taking part
- 1,004 people, planned
- Started
- 1 Jun 2020
- Expected to end
- Jun 2037
- Type of study
- Observational, 11 groups
- Treatments tested
- Shoulder arthroplasty
- Record updated
- 30 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Neurological pathologies compromising the shoulder stability
- Morbid obesity
- Muscular deficiencies impairing the shoulder joint
Where in France
Also in 1 other country, 1 site
- Chu Amiens PicardieAmiens, FranceContact: Kathy TRIER, PhDTaking people
- CHU d AngersAngers, FranceContact: LANCIGU, MDTaking people
- Hopital Jean MinjozBesançon, FranceContact: OBERT, Pr, MDTaking people
- Clinique AguiléraBiarritz, FranceContact: LEGER, MDTaking people
- Hôpital Privé Saint MartinCaen, FranceContact: DORDAIN, MDTaking people
- Infirmerie ProtestanteCaluire-et-Cuire, FranceContact: Thierry AUTHOM, MDTaking people
- CHMS ChambéryChambéry, FranceContact: Emmanuel BEAUDOUIN, MDTaking people
- Hôpitaux Civils de ColmarColmar, FranceContact: ROBIAL, MDTaking people
- Hôpital Privé Dijon BourgogneDijon, FranceContact: GONZALVEZ, MDTaking people
- Clinique Saint CharlesLa Roche-sur-Yon, FranceContact: HEIZMANN, MDTaking people
- Clinique chirurgicale Porte OcéaneLes Sables-d'Olonne, FranceContact: MARCHAND, MDTaking people
- Clinique Saint CharlesLyon, FranceContact: Thierry AUTHOM, MDTaking people
- L'Hôpital Privé du ConfluentNantes, FranceContact: BARGOIN, MDTaking people
- Clinique des MaussinsParis, FranceContact: Geoffroy NOURISSAT, MDTaking people
- Hôpital BichatParis, FranceContact: BOYER, Pr, MDTaking people
- Pavillon de la MutualitePessac, FranceContact: SEIVERTTaking people
- Clinique Saint Michel et Sainte AnneQuimper, FranceContact: SONNARD, MDTaking people
- Clinique MutualisteSaint-Etienne, FranceContact: BARAY, MDTaking people
- Polyclinique de l'AtlantiqueSaint-Herblain, FranceContact: PAUMIER, MDTaking people
- C. H. St- NazaireSaint-Nazaire, FranceContact: JAMARD, MDTaking people
- Clinique de l'OrangerieStrasbourg, FranceContact: ANTONI, MDTaking people
About the trial
What the trial wants to find out
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.
Read full original descriptionShow less
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
The 11 groups in the trial
- Group 1: HUMELOCK II® TSA
Subjects treated with HUMELOCK II® Anatomic Shoulder System
Treatment: Shoulder arthroplasty
- Group 21: cementless HUMELOCK II® RSA - trauma
Subjects treated with cementless HUMELOCK II® Reversible Shoulder System for traumatic indications
Treatment: Shoulder arthroplasty
- Group 22: cemented long HUMELOCK II® RSA - revision
Subjects treated with cemented long HUMELOCK II® Reversible Shoulder System for revision indications
Treatment: Shoulder arthroplasty
- Group 31: SHUMELOCK REVERSED® - degenerative
Subjects treated with HUMELOCK REVERSED® Shoulder System for degenerative indications
Treatment: Shoulder arthroplasty
- Group 32: HUMELOCK REVERSED® - trauma
Subjects treated with HUMELOCK REVERSED® Shoulder System for traumatic indications
Treatment: Shoulder arthroplasty
- Group 4: cementless HUMERIS® Anatomic - degenerative
Subjects treated with cementless HUMERIS® Anatomic Shoulder System for degenerative indications
Treatment: Shoulder arthroplasty
- Group 5: cementless HUMERIS® RSA - degenerative
Subjects treated with cementless HUMERIS® Reversible Shoulder System for degenerative indications
Treatment: Shoulder arthroplasty
- Group 6: EASYTECH® TSA - degenerative
Subjects treated with EASYTECH® Anatomic Shoulder System for degenerative indications
Treatment: Shoulder arthroplasty
- Group 7: EASYTECH® RSA - revision
Subjects treated with EASYTECH® Reversible Shoulder System for revision indications
Treatment: Shoulder arthroplasty
- Group 8: EASYTECH® RSA - degenerative
Subjects treated with EASYTECH® Reversed Shoulder System for degenerative indications
Treatment: Shoulder arthroplasty
- Group 33: HUMELOCK REVERSED® - revision
Subjects treated with HUMELOCK REVERSED® Shoulder System for revision indications
Treatment: Shoulder arthroplasty
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 April 2026