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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 747

Contacts and Locations

• Study Contact: Name: Marion Burland; Phone Number: +33 (0)4 66 28 06 85; Email: reg.aff@dedienne-sante.com

Study Locations

• France
  • Beaumont, France, 63110
    • Recruiting
    • Hôpital Privé de la Chataigneraie
  • Marmande, France, 47207
    • Terminated
    • CH de Marmande - CHIC
  • Montredon-des-Corbières, France, 11100
    • Recruiting
    • Hôpital Privé du Grand Narbonne
  • Nîmes, France, 30932
    • Recruiting
    • Polyclinique Grand Sud
  • Perpignan, France, 66140
    • Recruiting
    • Clinique Mutualiste Catalane
  • Péronne, France, 80200
    • Recruiting
    • CH de Péronne
  • Saint-Étienne, France, 83000
    • Recruiting
    • Clinique Mutualiste
  • Toulon, France, 83000
    • Recruiting
    • Hôpital d'Instruction des Armées Saint-Anne
  • Vantoux, France, 57070
    • Recruiting
    • Hôpital Robert Schuman - UNEOS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient requiring total hip arthroplasty

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SYMBOL medical devices; Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range	Device: Total hip arthroplasty (primary or revision); Total hip arthroplasty with at least one medical device from the SYMBOL range

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of all individual SYMBOL orthopaedic components	The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.	6 months, 18 months and 5 years post-operative
Survivorship of the SYMBOL STEM VARA CEM orthopaedic implant.	The survival rate of an orthopaedic implant will be calculated on the basis of the first occurrence of implant revision from any cause.	10 years post-operative
Survivorship of the SYMBOL implants by component assembly (acetabular + femoral components)	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.	Through study completion, an average of 10 years
Adverse Device Effects.	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.	Through study completion, an average of 10 years
Radiographic assessment - Implant subsidence.	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.	6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Osteolysis (granuloma).	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.	6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Radiolucent lines.	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.	6 months, 18 months, 5 and 10 years post-operative
Radiographic assessment - Eterotopic ossifications.	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.	6 months, 18 months, 5 and 10 years post-operative
Harris Hip Score (or modified Harris Hip Score) at each visit.	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.	Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
Pain intensity (Numeric Rating Scale)	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.	Pre-operative, 6 months, 18 months, 5 and 10 years post-operative
EQ-5D-5L score	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.	Pre-operative, 18 months, 5 and 10 years post-operative
Global patient satisfaction	Ordinal scale for global patient satisfaction assessment: - Possible values are: not satisfied/quite satisfied/satisfied/very satisfied ("Very satisfied" is the best possible outcome).	18 months post-operative
Hip joint patient satisfaction (Numeric Rating Scale)	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.	5 years and10 years post-operative

Collaborators and Investigators

• Sponsor: Dedienne Sante S.A.S.
• Collaborators: EVAMED
• Investigators: Principal Investigator: Thomas Rousseau, Clinique Mutualiste Catalane

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Hip Injuries; Osteoarthritis; Hip Fractures; Joint Diseases; Necrosis; Osteoarthritis, Hip; Femoral Neck Fractures
• Other Study ID Numbers: PMCF_SYMBOL_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No