Clinical trial NCT04094935: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture; Radius, Lower or Distal End
Keywords: Fracture of the radius
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients operated on for a fractured distal radius with an anterior locked plate in orthopaedic and trauma surgery in Saint Antoine Hospital, 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Screws exceeding the posterior cortical
timeFrame: 3 months
Secondary outcomes:
measure: Tendon complications
timeFrame: 3 months
measure: Secondary displacement or dismantling
timeFrame: 3 months
measure: Ablation of material or resumption early surgery
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: St Antoine hospital - orthopaedic and traumatic surgery
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier HERISSON, Dr
role: PRINCIPAL_INVESTIGATOR
References: