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Recruiting NCT05227924

Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

— Observational Degenerative Hip Joint Disease Post-traumatic Osteoarthritis Hip Arthritis Femoral Neck Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total hip arthroplasty (primary or revision).
Who it may be relevant to
Registry conditions: Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.

Interventions

  • Device Total hip arthroplasty (primary or revision)
    Total hip arthroplasty with at least one medical device from the SYMBOL range

Primary outcome measures

  • Survivorship of 13 individual SYMBOL orthopaedic components [Time frame: 10 years post-operative]
Secondary outcome measures (12)
  • Survivorship of all individual SYMBOL orthopaedic components [Time frame: 6 months, 18 months and 5 years post-operative]
  • Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant. [Time frame: 10 years post-operative]
  • Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components) [Time frame: Through study completion, an average of 10 years]
  • Adverse Device Effects. [Time frame: Through study completion, an average of 10 years]
  • Radiographic assessment - Implant subsidence. [Time frame: 6 months, 18 months, 5 and 10 years post-operative]
  • Radiographic assessment - Osteolysis (granuloma). [Time frame: 6 months, 18 months, 5 and 10 years post-operative]
  • Radiographic assessment - Radiolucent lines. [Time frame: 6 months, 18 months, 5 and 10 years post-operative]
  • Radiographic assessment - Eterotopic ossifications. [Time frame: 6 months, 18 months, 5 and 10 years post-operative]
  • Harris Hip Score (or modified Harris Hip Score) at each visit. [Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative]
  • Pain intensity (Numeric Rating Scale) [Time frame: Pre-operative, 6 months, 18 months, 5 and 10 years post-operative]
  • EQ-5D-5L score [Time frame: Pre-operative, 18 months, 5 and 10 years post-operative]
  • Global patient satisfaction [Time frame: 18 months post-operative]

Eligibility criteria

Inclusion criteria

  • Patient age > 18 years at implantation.
  • Patient who will undergo, during the study's period of inclusion, a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device (DEDIENNE Santé).
  • Patient informed of his/her participation and willing to participate in the study.
  • Patient able to read, write and understand French.

Exclusion criteria

  • Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
  • Patient unable to follow study procedures.
  • Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 9 centers
  • Hôpital Privé de la Châtaigneraie — Beaumont
  • CH de Marmande - CHIC — Marmande
  • Hôpital Privé du Grand Narbonne — Montredon-des-Corbières
  • Polyclinique Grand Sud — Nîmes
  • Clinique Mutualiste Catalane — Perpignan
  • CH de Péronne — Péronne
  • Clinique Mutualiste — Saint-Etienne
  • Hôpital d'Instruction des Armées Saint-Anne — Toulon
  • … and 1 more center

Identifiers

NCT: NCT05227924 · PMCF_SYMBOL_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗