Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate

Distal Intra-articular Radius Fracture With a Dorsal Tilt Clinical Trial

— PAPPO  

Official title:

Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03259906
• Other study ID #: ALVERNHE LABATTUT 2016
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation.

First-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications.

In the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients who have provided written informed consent

• Patients older than 45 years

• Patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages B2, C1, C2 and C3)

Exclusion Criteria:

• Adults under guardianship

• Patients without national health insurance cover

• Pregnant or breast-feeding women

• Patients presenting other injuries in the same upper limb

• Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers)

• Pre-trauma paralysis of the limb

• Open fracture

• Fracture with palmer tilt or extra-articular

Related Conditions & MeSH terms

• Distal Intra-articular Radius Fracture With a Dorsal Tilt
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• DASH score
Questionnaire asking about Disability of Arm, Shoulder and Hand

Procedure:
• X-ray
postoperative x-rays at 6 weeks, 3, 6 and 12 months
• posterior osteosynthesis
Osteosynthesis using a posterior plate
• Anterior osteosynthesis
Osteosynthesis using an anterior plate

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of functional recovery using the DASH questionnaire		6 months