Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 11:00 AM
Study NCT ID:
NCT04094935
Status:
UNKNOWN
Last Update Posted:
2019-11-18
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHORT
Brief Summary:
Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.
The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)
The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)
Detailed Description:
* Preoperative consultation
* Oral information of the patient of the protocol and delivery of the written information note
* Seeking patient's non-opposition to participating in the study
* Inclusion of the patient
* Surgical procedure for distal radius fracture + immediate post-operative radiography
* Intervention performed according to the usual practices of the service by the surgeon of the day without randomization
* Radiography: 2 shots: face and wrist profile
* Control X-ray + consultation
* Achieved at 3 weeks, 6 weeks and 3 months after the intervention
* X-rays: 2 shots: face and wrist profile
* Control ultrasound o Realized at 3 months after the intervention
End of participation in the study after consultation of 3 months.
* Oral information of the patient of the protocol and delivery of the written information note
* Seeking patient's non-opposition to participating in the study
* Inclusion of the patient
* Surgical procedure for distal radius fracture + immediate post-operative radiography
* Intervention performed according to the usual practices of the service by the surgeon of the day without randomization
* Radiography: 2 shots: face and wrist profile
* Control X-ray + consultation
* Achieved at 3 weeks, 6 weeks and 3 months after the intervention
* X-rays: 2 shots: face and wrist profile
* Control ultrasound o Realized at 3 months after the intervention
End of participation in the study after consultation of 3 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-A00429-48 | OTHER | ANSM | View |