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

GCS Ramsay Santé pour l'Enseignement et la Recherche408 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

408

Conditions

Arthroplasty

Interventions

Cohort observationOTHER

Cohort observation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Clinique du Sport

Paris, France

Outcomes

Primary Outcomes

Engh and Massin Score

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).

Time frame: 5 years

Secondary Outcomes

Stability of the femoral stem: axial migration (sinking)

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

Time frame: 5 years

Stability of the femoral stem: frontal migration (varisation)

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

Time frame: 5 years

Gruen's zones assessment

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

Time frame: 5 years

Periprosthetic ossifications (Brooker classification)

Time frame: 5 years

Periprosthetic fractures (Vancouver classification)

Time frame: 5 years

Harris Hip Score (HHS)

Data from ClinicalTrials.gov

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