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OpenTrials
Completed

NCT Number: NCT06096155

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

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.

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Key information

Conditions

Hip Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Loire Vendée Océan

Challans, Vendée, 85300, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Survival Rate at Mid/Long Term Follow-up

    Time frame: At 7/10 years after surgery

    Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision

Secondary outcomes

  1. Patient's Satisfaction

    Time frame: 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

  2. Adverse Events

    Time frame: At 7/10 years after surgery

    List type and occurence of adverse events

  3. Oblivion of Prosthesis

    Time frame: 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

  4. Absence of Squeaking

    Time frame: At 7/10 years after surgery

    Number of patients experiencing no squeaking

  5. Functional Improvement

    Time frame: At 7/10 years after surgery

    The only measure to be considered is "Modified Harris Hip Score" which consists of a 0 to 100 points scale (100 points is the better outcome). The data retrieved from site is only 1 figure ranging from 0 to 100.

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Acronym: 2022-09

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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