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

Fracture; Radius, Lower or Distal End Clinical Trial

— SHORT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094935
• Other study ID #: APHP 190158
• Secondary ID: 2019-A00429-48
• Status: Recruiting
• Start date: October 11, 2019
• Est. completion date: January 2021

Study information

• Verified date: November 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier HERISSON, Dr
• Email: olivierherisson[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fracture; Radius, Lower or Distal End
• Fractures, Bone

Locations

Country	Name	City	State
France	St Antoine hospital - orthopaedic and traumatic surgery	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screws exceeding the posterior cortical	Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.	3 months
Secondary	Tendon complications	Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.	3 months
Secondary	Secondary displacement or dismantling	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)	3 months
Secondary	Ablation of material or resumption early surgery	Proportion of ablation of material or resumption early surgery on secondary displacement rated at 3 months	3 months