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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00016-43 | Registry Identifier | French clinical trials database [ANSM] |
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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of the treated fracture and mobility improvement) / Technical performances (Percutaneous implantation by mini-invasive approach, Efficiency of percutaneous implementation and efficiency of percuatneous cementing) / Safety performances (Preservation of the screw stability after implantation and preservation of the screw integrity after implantation). The safety and performance data about the InnoFix® screw will be used to obtain their CE marking according to the regulation (EU) 2017/745.
The principal objective of this clinical investigation is to assess the postoperative reduction in pain level of the patient at 6 weeks follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult cancer patient with a non-displaced pelvic pathologic fracture | Experimental | The fracture of the patients, treated with InnoFix® screw, is stabilized with a percutaneous fixation by internal cemented screw. This procedure is carried out by mini-invasive approach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous fixation by internal cemented screw (InnoFix®) | Device | Percutaneous fixation by internal cemented screw |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients which have a pain reduction rate, at 6 weeks postoperatively, equal or superior to 30% | Pain reduction is measured with the VAS scale : Zero is equivalent to no pain and 10 indicates the worst possible pain | From the patient inclusion date to 6 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients which have a pain reduction rate, at 6 months postoperatively, equal or superior to 30% | The pain is measured with the VAS scale: Zero is equivalent to no pain and 10 indicates the worst possible pain | From the patient inclusion date to 6 months postoperatively |
| Rate of postoperative stable fractures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric DESCHAMPS | Contact | +33 (0)1 42 11 42 11 | frederic.deschamps@gustaveroussy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Lambros TSELIKAS | Gustave ROUSSY Cancer Institute - Villejuif | Principal Investigator |
| Xavier BUY | BERGONIE Institute - Bordeaux | Principal Investigator |
| Roberto Luigi CAZZATO |
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Sponsor commitment to not transfert data outside the European Union
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| ID | Term |
|---|---|
| D005598 | Fractures, Spontaneous |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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Fracture stability is assessed with medical imaging: Length of fracture line in millieter (complete fracture) or fracture occurernce (impending fracture) |
| From end surgery to 6 weeks and 6 months postoperatively |
| Rate of patients which have a mobility improvement rate postoperatively | Mobility is measured with ECOG scale: | From the patient inclusion date to 6 weeks and 6 months postoperatively |
| Implantation success rate of the InnoFix® screw | Implantation succes is measured with medical imaging: Screw position compared to the fracture line and distance, in millimeters, of the distal tip of screw compared to the planned area and protrusion, in millimeters, of the proximal part of screw from the external cortex | At the end of surgery |
| Satisfaction rate of the radiologist regarding the efficiency of the percutaneous implementation | Efficiency of percutaneous implementation is based on the experiency of the radaiologist | At the end of surgery |
| Satisfaction rate of the radiologist regarding the efficiency of the percutaneous cementing | Efficiency of percutaneous cementing is based on the experiency of the radaiologist | At the end of surgery |
| Rate of stable InnoFix® screws postoperatively | Screw stability is measured with medical imaging: Screw displacement in millimeters and contact with anatomical structures or other implanted devices | From end surgery to 6 weeks and 6 months postoperatively |
| Rate of InnoFix® screws with their integrity preserved postoperatively | Screw integrity is measured with medical imaging: Disassembly, breakage or bending in millimeters | From end surgery to 6 weeks and 6 months postoperatively |
| Rate of patient which have had, at least, one adverse event in relation with the InnoFix® screw postoperatively | Adverse event reported | From the patient inclusion date to 6 months postoperatively |
| Rate of patient which have had, at least, one serious adverse event in relation with the InnoFix® screw postoperatively | Serious adverse event reported | From the patient inclusion date to 6 months postoperatively |
| Strasbourg Civil Hospital - Strasbourg |
| Principal Investigator |