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

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227924
• Other study ID #: PMCF_SYMBOL_01
• Status: Recruiting
• Start date: September 15, 2021
• Est. completion date: September 2034

Study information

• Verified date: March 2023
• Source: Dedienne Sante S.A.S.
• Contact: Marion Burland
• Phone: +33 (0)4 66 28 06 85
• Email: reg.aff[@]dedienne-sante.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 747
• Est. completion date: September 2034
• Est. primary completion date: September 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Head
• Degenerative Hip Joint Disease
• Failure of Prosthetic Joint Implant
• Femoral Neck Fractures
• Hip Arthritis
• Joint Diseases
• Necrosis
• Osteoarthritis, Hip
• Post-traumatic Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
France	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	CH de Péronne	Péronne
France	Clinique Mutualiste Catalane	Perpignan
France	Clinique Mutualiste	Saint-Étienne
France	Hôpital d'Instruction des Armées Saint-Anne	Toulon
France	Hôpital Robert Schuman - UNEOS	Vantoux

Sponsors (2)

Lead Sponsor	Collaborator
Dedienne Sante S.A.S.	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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