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

Recruiting

• Conditions: Femoral Neck Fractures; Failure of Prosthetic Joint Implant; Hip Arthritis; Avascular Necrosis of the Femoral Head; Post-traumatic Osteoarthritis; Degenerative Hip Joint Disease
• Interventions: Device: Total hip arthroplasty (primary or revision)

• Registration Number: NCT05227924
• Lead Sponsor: Dedienne Sante S.A.S.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-21
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2034-09
• Study Completion: 2034-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 747

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SYMBOL medical devices	Total hip arthroplasty (primary or revision)	Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range

Primary Outcome Measures

Name	Time	Method
Survivorship of 13 individual SYMBOL orthopaedic components	10 years post-operative	The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.

Secondary Outcome Measures

Name	Time	Method
Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.	10 years post-operative	The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Radiographic assessment - Implant subsidence.	6 months, 18 months, 5 and 10 years post-operative	Stem subsidence will be classified based on the following: * Stem subsidence \< 3mm; * Stem subsidence between 3 and 5mm; * Stem subsidence \> 5mm; Note: This outcome will also be used for subgroup analyses by component association.
Radiographic assessment - Eterotopic ossifications.	6 months, 18 months, 5 and 10 years post-operative	Assessment will consider: - Presence or absence of eterotopic ossifications. If eterotopic ossification, grade will be specified.; This outcome will also be measured for subgroup analyses by component association.
Survivorship of all individual SYMBOL orthopaedic components	6 months, 18 months and 5 years post-operative	The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.
Adverse Device Effects.	Through study completion, an average of 10 years	All adverse device effects occurring from the time of subject enrollment until study termination or study completion including intra-operative adverse events.; Note: This outcome will also be used for subgroup analyses by component association.
Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)	Through study completion, an average of 10 years	The survival rate of a combinaison of implant (acetabular + femoral component) will be calculated on the basis of the first occurrence of implant revision from any cause.
Global patient satisfaction	18 months post-operative	Ordinal scale for global patient satisfaction assessment: - Possible values are: not satisfied/quite satisfied/satisfied/very satisfied ("Very satisfied" is the best possible outcome).
Radiographic assessment - Osteolysis (granuloma).	6 months, 18 months, 5 and 10 years post-operative	Assessment will consider: - Presence or absence of osteolysis. If osteolysis is present, impacted areas will be determined according to DeLee and Charnley or Gruen classification.; Note: This outcome will also be used for subgroup analyses by component association.
Pain intensity (Numeric Rating Scale)	Pre-operative, 6 months, 18 months, 5 and 10 years post-operative	Numeric Rating scale for pain intensity assessment: * Minimum value: 0 (=no pain); * Maximum value: 10 (= worst possible pain). (Higher scores mean worst outcome).; Note: This outcome will also be used for subgroup analyses by component association.
Radiographic assessment - Radiolucent lines.	6 months, 18 months, 5 and 10 years post-operative	Assessment will consider: - Presence or absence of radiolucent lines.; If radiolucent line is present: * Impacted areas will be determined according to DeLee and Charnley or Gruen classification.; * Type of radiolucent lines will be classified based on the following : \< 2mm - regular or \> 2mm - irregular.; Note: This outcome will also be used for subgroup analyses by component association.
Harris Hip Score (or modified Harris Hip Score) at each visit.	Pre-operative, 6 months, 18 months, 5 and 10 years post-operative	The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain, function, functional activities, absence of deformity, and hip range of motion.; Note: This outcome will also be used for subgroup analyses by component association.
EQ-5D-5L score	Pre-operative, 18 months, 5 and 10 years post-operative	The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.; The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale.; Note: This outcome will also be used for subgroup analyses by component association.
Hip joint patient satisfaction (Numeric Rating Scale)	5 years and10 years post-operative	Numeric rating scale : Percentage Scale for Hip Joint Patient Satisfaction Assessment.; Range of values: from 0 to 100. (100 is the best possible outcome and is equivalent to a normal hip).; Note: This outcome will also be used for subgroup analyses by component association.

Trial Locations

Locations (9)

Hôpital Privé de la Châtaigneraie; 🇫🇷 Beaumont, France

CH de Marmande - CHIC; 🇫🇷 Marmande, France

Hôpital Privé du Grand Narbonne; 🇫🇷 Montredon-des-Corbières, France

Polyclinique Grand Sud; 🇫🇷 Nîmes, France

Clinique Mutualiste Catalane; 🇫🇷 Perpignan, France

Clinique Mutualiste; 🇫🇷 Saint-Étienne, France

Hôpital Robert Schuman - UNEOS; 🇫🇷 Vantoux, France

CH de Péronne; 🇫🇷 Péronne, France

Hôpital d'Instruction des Armées Saint-Anne; 🇫🇷 Toulon, France