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Completed

NCT Number: NCT05015101

Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating

Evaluation of the clinical and radiological outcome of uncemented femoral stems according to their proximal coating.

Retrospective study

Completed

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Key information

Conditions

Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Sport

Paris, 75005, France

About this study

On a large population of patients having undergone total hip arthroplasty, divided into two cohorts constituted according to the type of femoral stem implanted (with or without proximal coating by MectaGrip):

Primary objective: To compare between the two groups the radiological osseointegration of the stems five years after arthroplasty.

Secondary objectives: To compare between the groups

  • The functional outcome of the arthroplasty
  • The frequency of radiological abnormalities (stress shielding, osteolysis, periprosthetic fractures or cracks, periprosthetic ossifications)
  • Frequency of complications

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient aged 18 years or older, having been informed of the research
  • A patient with at least five years of uncemented total hip replacement implanted as a first-line procedure
  • A patient who has been regularly monitored since surgery and for whom all clinical and radiological data are available at the five-year follow-up visit

Exclusion criteria

  • Patient operated for revision
  • History of femoral fracture (pre or per operative)
  • Chronic treatment likely to affect calcium metabolism and ossification
  • Patient under legal protection, guardianship or curatorship
  • A patient who has indicated his or her opposition to the use of his or her medical data (by completing and returning the non-opposition form that will be sent to him or her).

Treatment and study plan

Cohort observation

Other

Cohort observation

Primary outcomes

  1. Engh and Massin Score

    Time frame: 5 years

    The osseointegration of each stem will be assessed by the Engh and Massin score which evaluates the fixation (bone margins and bridges) and the stability of the stem (margins, pedestal, remodelling of the calcar, deterioration of the prosthesis-bone interface, migration, and particles) by associating negative or positive values for each of the parameters. The total constitutes an anatomopathological diagnosis of "confirmed bone rehab" (+ 10 pts and more), suspected (between 0 and + 10 pts), "fibrous encapsulation" (between - 10 and 0 pts) or an "unstable" prosthesis (below - 10 pts).

Secondary outcomes

  1. Stability of the femoral stem: axial migration (sinking)

    Time frame: 5 years

    Radiological assessment of the stability of the femoral stem: axial migration (sinking)

  2. Stability of the femoral stem: frontal migration (varisation)

    Time frame: 5 years

    Radiological assessment of the stability of the femoral stem: frontal migration (varisation)

  3. Gruen's zones assessment

    Time frame: 5 years

    Images of edging, osteolysis, stress shielding according to Gruen's zones

  4. Periprosthetic ossifications (Brooker classification)

    Time frame: 5 years

    Periprosthetic ossifications (Brooker classification)

  5. Periprosthetic fractures (Vancouver classification)

    Time frame: 5 years

    Periprosthetic fractures (Vancouver classification)

  6. Harris Hip Score (HHS)

    Time frame: 5 years

    The Harris Hip Score (HHS) consists of a history part and a clinical examination part that takes into account pain, function and mobility of the hip. A score between 90 and 100 points is defined as excellent, between 80 and 90 as good, between 70 and 80 as fair and below 70 as poor.

  7. Oxford hip score

    Time frame: 5 years

    The Oxford score is a self-assessment of hip joint function consisting of 12 questions scored from 0 to 4. The total score is calculated by adding up the results of each question. The lower the score, the more severe the functional impact.

  8. Forgotten Joint Score

    Time frame: 5 years

    Le Forgotten Joint Score (FJS-12), est un auto-questionnaire compose de 12 questions évaluant le degré d'oubli des prothèses de hanche dans une situation donnée de la vie quotidienne. Chaque réponse est choisie dans une échelle de Likert à 5 points avec les options de réponse allant de jamais (0) la plupart du temps (4).

  9. Life span of prostheses

    Time frame: 5 years

    The life span is the time between the implantation of the prosthesis and its complete or partial surgical revision.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating.

Acronym: ETNA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2021
Registry last updated
Jul 1, 2024

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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