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

Completed

• Conditions: Arthroplasty

• Registration Number: NCT05015101
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-20
• Study Start: 2021-09-30
• Primary Completion: 2021-12-26
• Study Completion: 2021-12-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Engh and Massin Score	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 Outcome Measures

Name	Time	Method
Stability of the femoral stem: axial migration (sinking)	5 years	Radiological assessment of the stability of the femoral stem: axial migration (sinking)
Stability of the femoral stem: frontal migration (varisation)	5 years	Radiological assessment of the stability of the femoral stem: frontal migration (varisation)
Gruen's zones assessment	5 years	Images of edging, osteolysis, stress shielding according to Gruen's zones
Forgotten Joint Score	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).
Life span of prostheses	5 years	The life span is the time between the implantation of the prosthesis and its complete or partial surgical revision.
Oxford hip score	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.
Periprosthetic ossifications (Brooker classification)	5 years	Periprosthetic ossifications (Brooker classification)
Periprosthetic fractures (Vancouver classification)	5 years	Periprosthetic fractures (Vancouver classification)
Harris Hip Score (HHS)	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.

Trial Locations

Locations (1)

Clinique du Sport; 🇫🇷 Paris, France