Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
- Conditions
- Hip Arthropathy
- Registration Number
- NCT06096155
- 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 61
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival rate at mid/long term follow-up At 7/10 years after surgery Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision
- Secondary Outcome Measures
Name Time Method Oblivion of prosthesis At 7/10 years after surgery 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
Pain release At 7/10 years after surgery 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).Patient's satisfaction At 7/10 years after surgery Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied
Adverse events At 7/10 years after surgery List type and occurence of adverse events
Functional improvement At 7/10 years after surgery 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).
Trial Locations
- Locations (1)
Centre Hospitalier Loire Vendée Océan
🇫🇷Challans, Vendée, France