Humeral Fracture, Proximal, Revision of a Shoulder Prosthesis
Conditions
Brief summary
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the HUMELOCK II(r) long cemented humeral stem (shoulder prosthesis) 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 * Constant Score, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Pain score (VAS) 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
Detailed description
Recruitment of patients can be retrospective or prospective, mainly retrospectively. Follow-up will be prospective from the date of study inception. Recruitment will include all cases available at the selected investigation centers. 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
PROCEDUREShoulder arthroplasty
Hemi anatomical (HSA) or reversed (RSA) shoulder arthroplasties.
Sponsors
FX Solutions
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for hemi anatomic or total reversible shoulder replacement with Long Cemented HUMELOCK II® humeral stem for Trauma or Revision indication, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision rate (KM) at 10 years postoperative | at the end of the postoperative follow-up period of 10 years | Survival rate (%) at 10 years calculated by means of Kaplan-Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision rate (KM) at each postoperative visit | At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years) | Survival rate (%) at each postoperative visit calculated by means of Kaplan-Meier method |
| Range of Motions at each postoperative visit | 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 postopererative visit | At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years) | The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function and the lower the pain is. |
| ASES score at each postoperative visit | At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years) | ASES (American Shoulder and Elbow Surgeons) score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function. |
| VAS pain at each postoperative visit | At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years) | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). |
| Radiological assessment of implant positioning at each postoperative visit | 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 | At each postoperative visit (6 weeks, 3 or 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years) | — |
Countries
France
Contacts
CONTACTKathy TRIER, PhD
CONTACTGabriel GUEUGNON
Outcome results
None listed