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 Type
OBSERVATIONAL
Enrollment
747
Total hip arthroplasty with at least one medical device from the SYMBOL range
Hôpital Privé de la Châtaigneraie
Beaumont, France
RECRUITINGCH de Marmande - CHIC
Marmande, France
TERMINATEDHôpital Privé du Grand Narbonne
Montredon-des-Corbières, France
RECRUITINGPolyclinique Grand Sud
Nîmes, France
RECRUITINGClinique Mutualiste Catalane
Perpignan, France
RECRUITINGCH de Péronne
Péronne, France
RECRUITINGClinique Mutualiste
Saint-Etienne, France
RECRUITINGHôpital d'Instruction des Armées Saint-Anne
Toulon, France
RECRUITINGHôpital Robert Schuman - UNEOS
Vantoux, France
RECRUITINGSurvivorship 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.
Time frame: 10 years post-operative
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 5 years and10 years post-operative
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