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

Arthroplasty Clinical Trial

— ETNA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05015101
• Other study ID #: COS-RGDS-2019-12-012
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Frédéric LAUDE, MD
• Phone: 06 03 44 45 45
• Email: flaude[@]mac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Retrospective study

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 408
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthroplasty

Intervention

Other:
• Cohort observation
Cohort observation

Locations

Country	Name	City	State
France	Clinique du Sport	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stability of the femoral stem: axial migration (sinking)	Radiological assessment of the stability of the femoral stem: axial migration (sinking)	5 years
Secondary	Stability of the femoral stem: frontal migration (varisation)	Radiological assessment of the stability of the femoral stem: frontal migration (varisation)	5 years
Secondary	Gruen's zones assessment	Images of edging, osteolysis, stress shielding according to Gruen's zones	5 years
Secondary	Periprosthetic ossifications (Brooker classification)	Periprosthetic ossifications (Brooker classification)	5 years
Secondary	Periprosthetic fractures (Vancouver classification)	Periprosthetic fractures (Vancouver classification)	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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