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

NCT05015101 | Completed

• 1 other identifier: COS-RGDS-2019-12-012
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Stability of the femoral stem: axial migration (sinking)

  5 years

• Stability of the femoral stem: frontal migration (varisation)

  5 years

• Gruen's zones assessment

  5 years

• Periprosthetic ossifications (Brooker classification)

  5 years

• Periprosthetic fractures (Vancouver classification)

  5 years

Interventions

Cohort observation OTHER

Cohort observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique du Sport

Paris, 75005, France

Location

Study Officials

• Frédéric LAUDE, MD PD

  Clinique du sport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: September 30, 2021
• Primary Completion: December 26, 2021
• Study Completion: December 26, 2021
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)