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

Completed

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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	Between 4 to 7 years after surgery	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.

Secondary Outcome Measures

Name	Time	Method
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
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)
Adverse Events	From per operative period to 4/6 years after surgery	List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice
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
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. Percentage of patients with implant in place dispatched following reason for implantation
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

Trial Locations

Locations (1): Centre Hospitalier de Rouen - Hôpital Charles Nicolle
🇫🇷
Rouen, Seine Maritime, France
Centre Hospitalier de Rouen - Hôpital Charles Nicolle
🇫🇷Rouen, Seine Maritime, France