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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05015101
Acronym
ETNA
Enrollment
408
Registered
2021-08-20
Start date
2021-09-30
Completion date
2021-12-26
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty

Brief summary

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

Detailed description

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

Interventions

Cohort observation

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Engh and Massin Score5 yearsThe 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

MeasureTime frameDescription
Stability of the femoral stem: frontal migration (varisation)5 yearsRadiological assessment of the stability of the femoral stem: frontal migration (varisation)
Gruen's zones assessment5 yearsImages of edging, osteolysis, stress shielding according to Gruen's zones
Periprosthetic ossifications (Brooker classification)5 yearsPeriprosthetic ossifications (Brooker classification)
Periprosthetic fractures (Vancouver classification)5 yearsPeriprosthetic fractures (Vancouver classification)
Stability of the femoral stem: axial migration (sinking)5 yearsRadiological assessment of the stability of the femoral stem: axial migration (sinking)
Oxford hip score5 yearsThe 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.
Forgotten Joint Score5 yearsLe 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).
Life span of prostheses5 yearsThe life span is the time between the implantation of the prosthesis and its complete or partial surgical revision.
Harris Hip Score (HHS)5 yearsThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026