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

Hip Arthropathy Clinical Trial

— 2022-09  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096155
• Other study ID #: 2022-09_Sagitta EVL-R
• Status: Recruiting
• Start date: June 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• 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 01/01/2010 and 31/12/2015,

• Affiliated to French health insurance system

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Locations

Country	Name	City	State
France	Centre Hospitalier Loire Vendée Océan	Challans	Vendée

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/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	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 7/10 years after surgery
Secondary	Adverse events	List type and occurence of adverse events	At 7/10 years after surgery
Secondary	Oblivion of prosthesis	Assess the degree of forgetfulness of the prosthesis using FJS-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 7/10 years after surgery
Secondary	Pain release	Evaluate pain using Modified Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome).; The pain evaluation is picked out from the global Harris Hip Score. The pain item is scored on a 0 to 44 points scale (44 points means no pain).	At 7/10 years after surgery
Secondary	Functional improvement	Evaluate walking, limping and activities of daily life using Modified Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome).; The functional improvement is picked out from the global Harris Hip Score and can be measured with 3 subscores : The walking ablility is assessed by 2 items (support for walk and distance walked, each one is scored a 0 to 11 points scale (11 points is the better outcome).; The limping is assessed by a 0 to 11 points scale (11 points is the better outcome).; The activities of daily life are assessed by a 0 to 14 points scale (14 points is the better outcome).	At 7/10 years after surgery