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

Hip Arthropathy Clinical Trial

— 2022-10  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096168
• Other study ID #: 2022-10_Sagitta EVL-R
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: Lydie BONNEVAY
• Phone: 04 72 05 60 10
• Email: l.bonnevay[@]serf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Locations

Country	Name	City	State
France	Centre Hospitalier de Rouen - Hôpital Charles Nicolle	Rouen	Seine Maritime

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate at mid term follow-up	Assess the survival rate at least, 4 year-follow-up, whatever the cause of revision	At 4/6 years after surgery
Secondary	Adverse events	List type and occurence of adverse events, investigated by clinical and radiological examination following investigator's usual practice	From per operative period to 4/6 years after surgery
Secondary	Survival rates at mid term follow-up (by component)	Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis	At 4/6 years after surgery
Secondary	Survival rates at mid term follow-up (by etiology)	Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology	At 4/6 years after surgery
Secondary	Patient's satisfaction	Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied	At 4/6 years after surgery
Secondary	Oblivion of prosthesis	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	At 4/6 years after surgery
Secondary	Functional improvement	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)	At 4/6 years after surgery