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

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty
• Intervention / Treatment: Other: Cohort observation

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 Type: Observational
• Enrollment (Actual): 408

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Clinique du Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a total hip replacement for at least five years.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Frédéric LAUDE, MD PD, Clinique du Sport

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): December 26, 2021
• Study Completion (Actual): December 26, 2021

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: COS-RGDS-2019-12-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No