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

NCT ID: NCT05015101

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

408 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2021-12-26

Brief Summary

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

Retrospective study

Detailed Description

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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

Conditions

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Arthroplasty

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Cohort observation

Cohort observation

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric LAUDE, MD PD

Role: PRINCIPAL_INVESTIGATOR

Clinique du sport

Locations

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Clinique du Sport

Paris, , France

Site Status

Countries

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France

Other Identifiers

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COS-RGDS-2019-12-012

Identifier Type: -

Identifier Source: org_study_id

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