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

Recruiting

• Conditions: Hip Arthropathy

• Registration Number: NCT06096168
• Lead Sponsor: Societe dEtude, de Recherche et de Fabrication

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-13
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate at mid term follow-up	At 4/6 years after surgery	Assess the survival rate at least, 4 year-follow-up, whatever the cause of revision

Secondary Outcome Measures

Name	Time	Method
Adverse events	From per operative period to 4/6 years after surgery	List type and occurence of adverse events, investigated by clinical and radiological examination following investigator's usual practice
Oblivion of prosthesis	At 4/6 years after surgery	Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) : FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities
Survival rates at mid term follow-up (by component)	At 4/6 years after surgery	Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis
Functional improvement	At 4/6 years after surgery	Evaluate pain, walking, limping and activities of daily life using Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome)
Patient's satisfaction	At 4/6 years after surgery	Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied
Survival rates at mid term follow-up (by etiology)	At 4/6 years after surgery	Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology

Trial Locations

Locations (1)

Centre Hospitalier de Rouen - Hôpital Charles Nicolle; 🇫🇷 Rouen, Seine Maritime, France