Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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 - 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient age > 18 years at implantation.
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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).
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Patient informed of his/her participation and willing to participate in the study.
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Patient able to read, write and understand French.
Exclusion Criteria:
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Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
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Patient unable to follow study procedures.
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Patient who has already been included in the study for a total hip arthroplasty (primary or revision) with at least one SYMBOL medical device.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH de Marmande - CHIC | Marmande | France | 47207 | |
| 2 | CH du Forez | Montbrison | France | 42600 | |
| 3 | Clinique Mutualiste Catalane | Perpignan | France | 66140 | |
| 4 | CH de Péronne | Péronne | France | 80200 | |
| 5 | Hôpital d'Instruction des Armées Saint-Anne | Toulon | France | 83000 |
Sponsors and Collaborators
- Dedienne Sante S.A.S.
- EVAMED
Investigators
- Principal Investigator: Thomas Rousseau, Clinique Mutualiste Catalane
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMCF_SYMBOL_01