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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Arthropathy
• Intervention / Treatment: Device: Total Hip Arthroplasty Revision

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Chu de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Recruitment 120 adults patients representing 124 hips operated between 2011 and 2014.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival Rate of Stems	at 5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	The information will be collected from the patient by answering a Yes/No question at last follow-up. The following result correspond to the number of patients that have been satisfied	at 5 years follow-up
Functional Improvement	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the improvement in 3 scales: improved/unchanged/Worsen. The result present number of patient answering improved.	at 5 years follow-up
Pain Release	The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation. The patient will estimate the pain diminution with 2 options: Yes or No diminution of pain. Result presents the number of patient having pain diminution	at 5 years follow-up

Collaborators and Investigators

• Sponsor: Societe dEtude, de Recherche et de Fabrication
• Investigators: Principal Investigator: Louis-Etienne GAYET, MD, Poitiers University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Girard J, Roche O, Wavreille G, Canovas F, Le Beguec 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 2019-06-EVLR-N