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

Hip Arthropathy Clinical Trial

Official title:

Retro-prospective and Observational Study of 120 Patients for the Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153473
• Other study ID #: 2019-06-EVLR-N
• Status: Completed
• Start date: June 24, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: December 2021
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 8, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Device:
• Total Hip Arthroplasty Revision
Hip revision surgery is performed to repair an artificial hip joint (prosthesis) that has been damaged over time due to an infection, or due to normal wear and tear of the prosthetic hip. Revision surgery helps to correct the problem so the hip can function normally again.

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

References & Publications (5)

Delaunay C, Epinette JA, Dawson J, Murray D, Jolles BM. Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population. Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. doi: 10.1016/j.otsr.2009.01.003. Epub 2009 Apr 3. — View Citation

Girard J, Roche O, Wavreille G, Canovas F, Le Béguec P. Stem subsidence after total hip revision: 183 cases at 5.9 years follow-up. Orthop Traumatol Surg Res. 2011 Apr;97(2):121-6. doi: 10.1016/j.otsr.2010.10.006. Epub 2011 Mar 23. — View Citation

Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141. — View Citation

Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6. — View Citation

Tangsataporn S, Safir OA, Vincent AD, Abdelbary H, Gross AE, Kuzyk PR. Risk Factors for Subsidence of a Modular Tapered Femoral Stem Used for Revision Total Hip Arthroplasty. J Arthroplasty. 2015 Jun;30(6):1030-4. doi: 10.1016/j.arth.2015.01.009. Epub 2015 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate according to Kaplan-Meier		Between 5 and 8 years
Secondary	Patient Satisfaction	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation	Between 5 and 8 years
Secondary	Functional improvement	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation	Between 5 and 8 years
Secondary	Pain release	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation	Between 5 and 8 years