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| Name | Class |
|---|---|
| EVAMED | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYMBOL medical devices | Patients undergoing total hip arthroplasty with at least one medical device from the SYMBOL range |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty (primary or revision) | Device | Total hip arthroplasty with at least one medical device from the SYMBOL range |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient requiring total hip arthroplasty
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion Burland | Contact | +33 (0)4 66 28 06 85 | reg.aff@dedienne-sante.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Rousseau | Clinique Mutualiste Catalane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé de la Châtaigneraie | Recruiting | Beaumont | 63110 | France | ||
| CH de Marmande - CHIC |
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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:
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:
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:
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 |
| Terminated |
| Marmande |
| 47207 |
| France |
| Hôpital Privé du Grand Narbonne | Recruiting | Montredon-des-Corbières | 11100 | France |
| Polyclinique Grand Sud | Recruiting | Nîmes | 30932 | France |
| Clinique Mutualiste Catalane | Recruiting | Perpignan | 66140 | France |
| CH de Péronne | Recruiting | Péronne | 80200 | France |
| Clinique Mutualiste | Recruiting | Saint-Etienne | 83000 | France |
| Hôpital d'Instruction des Armées Saint-Anne | Recruiting | Toulon | 83000 | France |
| Hôpital Robert Schuman - UNEOS | Recruiting | Vantoux | 57070 | France |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D005265 | Femoral Neck Fractures |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| D024162 | Second-Look Surgery |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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