Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

NCT06096155 | Completed Results

• 1 other identifier: 2022-09_Sagitta EVL-R
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices. The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems. Secondary objectives are to :

• study long term patient satisfaction with their hip prosthesis,
• confirm the long-term safety of these implants by studying the possible complications observed,
• evaluate the performance of these implants using clinical scores.

Conditions

Hip Arthropathy

Keywords

Total Hip Prosthesis Revision

Outcome Measures

Primary Outcomes (1)

• Survival Rate at Mid/Long Term Follow-up

  Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision

  At 7/10 years after surgery

Secondary Outcomes (5)

• Patient's Satisfaction

  At 7/10 years after surgery

• Adverse Events

  At 7/10 years after surgery

• Oblivion of Prosthesis

  At 7/10 years after surgery

• Absence of Squeaking

  At 7/10 years after surgery

• Functional Improvement

  At 7/10 years after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who needed a revision of total hip arthroplasty, implanted with a SAGITTA EVL-R revision femoral stem according to instructions for use, over a period of time between 31/01/2010 and 31/12/2015.

You may qualify if:

• Patient over 18 years old at the time of surgery,
• Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015,
• Affiliated to French health insurance system

You may not qualify if:

• Patient who has rejected to the use of his/her personal data,
• Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

Centre Hospitalier Loire Vendée Océan

Challans, Vendée, 85300, France

Location

Limitations and Caveats

Considering the retrospective aspect of this investigation, some preoperative data are missing or incomplete.

Results Point of Contact

• Title: Sponsor
• Organization: SERF

clinical@serf.fr

+33 4.72.05.60.10

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: June 13, 2023
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2025-04

Locations

FR (1)