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

• Conditions: Fracture; Radius, Lower or Distal End

• Registration Number: NCT04094935
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)

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.

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Study Start: 2019-10-11
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18
• Primary Completion: 2020-10
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 years old
• Fracture (s) of extra joint distal radius with or without joint refend in the sagitta plane
• Osteosynthesis by anterior locked plate
• Patient who did not oppose his participation in this research

Exclusion Criteria

• Distal radius fractures with joint refend frontal (posterior marginal)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screws exceeding the posterior cortical	3 months	Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.

Secondary Outcome Measures

Name	Time	Method
Tendon complications	3 months	Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.
Secondary displacement or dismantling	3 months	Proportion of secondary displacement or dismantling 3-month control radio equipment (change of the radial slope on the face and radial glene's anversion on the profile between X-rays at J0 and control x-rays)
Ablation of material or resumption early surgery	3 months	Proportion of ablation of material or resumption early surgery on secondary displacement rated at 3 months

Trial Locations

Locations (1)

St Antoine hospital - orthopaedic and traumatic surgery; 🇫🇷 Paris, France