Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems

NCT06096168 | Completed Results

• 1 other identifier: 2022-10_Sagitta EVL-R
• Study Type: observational
• Target: 42
• 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. In order to reflect current practice, a comprehensive and continuous series of patients will be included. 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.

Conditions

Hip Arthropathy

Keywords

Total Hip Prosthesis Revision

Outcome Measures

Primary Outcomes (1)

• Survival Rate at Mid Term Follow-up

  Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.

  Between 4 to 7 years after surgery

Secondary Outcomes (6)

• Adverse Events

  From per operative period to 4/6 years after surgery

• Survival Rates at Mid Term Follow-up (by Component)

  At 4/6 years after surgery

• Survival Rates at Mid Term Follow-up (by Etiology)

  At 4/6 years after surgery

• Patient's Satisfaction

  At 4/6 years after surgery

• Oblivion of Prosthesis

  At 4/6 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 31/01/2016 and 31/12/2018.

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 01/01/2016 and 31/12/2018,
• Affiliated to French health insurance system

You may not qualify if:

• Patient who has not expressed consent for data collection and participation in the study,
• Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
• Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
• Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

Centre Hospitalier de Rouen - Hôpital Charles Nicolle

Rouen, Seine Maritime, 76000, France

Location

Results Point of Contact

• Title: Sponsor
• Organization: SERF

clinical@serf.fr

0472056010

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: April 13, 2023
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-04

Locations

FR (1)