Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

Study Research and Manufacturing Company (SERF)

Status: Completed

Conditions: Hip Arthropathy

Treatments: Device: Total Hip Arthroplasty Revision

Study type: Observational

Funder types: Industry

Identifiers

NCT05153473

2019-06-EVLR-N

Details and patient eligibility

About

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. Revision risk factors reported when considering the main surgical approaches. Studied from the Dutch arthroplasty registry found a revision rate in hemiarthroplasty (HA) of 1.6% at 1 year and 2.5% at 5 years postoperatively. For total hip replacement (THA), the rate was 2.4% at 1 and 4.3% at 5 years postoperatively. Analyze shows that the risk factors for hemiarthroplasty were male sex, age under 80 (regardless of gender), posterolateral approach and uncemented fixation. The risk factors for HAT were exactly the same, but they found that smoking also played a role. It should be noted that age as a risk factor for revision is not a risk during the first year after the fracture, but becomes one in the years that follow.

In order to maintain compliance with the directive on medical devices (93/42 / EEC [M5]) and the future regulation (EU) (2017/745) relating to medical devices, SERF has set up post-market clinical follow-ups ( PMCF). This PMCF study aims to improve knowledge related to the performance, safety and benefit / risk ratio of the Sagitta EVL-R stem and to monitor patient care strategy through this clinical evaluation. Significant clinical results as well as safety must be confirmed with this patient cohort. It is important to note that this cohort reflects the specific care strategy of the University Hospital of Poitiers. Therefore, the strategy could be different between hospitals and countries.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old.
• Patients that were treated with the sagitta EVL-R stem for an indication of arthroplasty and according to the Instruction For Use (IFU).
• Primary or secondary arthrosis,
• Advanced joint destruction resulting from rheumatoid arthritis or traumatic arthritis,
• A fracture or an avascular necrosis,
• Following a previous surgical operation, on condition that the new device does not interfere with the material in place.
• indicated in the case of primary or secondary arthrosis, displaced sub-capital or transcervical fracture as well as stages I and IIB bone loss according to the PAPROWSKI classification.
• The SAGITTA EVOLUTION for REVISION implant is recommended for indications according to the bone loss classifications of SOFCOT stages I to VI, PAPROSKY types I to VI and the AAOS types Ia to Ic.
• Dysplasia

Exclusion criteria

• Patient presenting a contraindication indicated in the IFU.

Trial design