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Completed

NCT Number: NCT06096168

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

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.

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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 de Rouen - Hôpital Charles Nicolle

Rouen, Seine Maritime, 76000, 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 01/01/2016 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

Treatment and study plan

Primary outcomes

  1. Survival Rate at Mid Term Follow-up

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: 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

  2. Survival Rates at Mid Term Follow-up (by Component)

    Time frame: 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

  3. Survival Rates at Mid Term Follow-up (by Etiology)

    Time frame: 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

  4. Patient's Satisfaction

    Time frame: 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

  5. Oblivion of Prosthesis

    Time frame: 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

  6. Functional Improvement

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Societe dEtude, de Recherche et de Fabrication

Industry

Registry information

Acronym: 2022-10

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Jun 25, 2025

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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