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

NCT ID: NCT03259906

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-04

Brief Summary

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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.

Detailed Description

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Conditions

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Distal Intra-articular Radius Fracture With a Dorsal Tilt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Osteosynthesis using a posterior plate

Group Type ACTIVE_COMPARATOR

DASH score

Intervention Type OTHER

Questionnaire asking about Disability of Arm, Shoulder and Hand

X-ray

Intervention Type PROCEDURE

postoperative x-rays at 6 weeks, 3, 6 and 12 months

posterior osteosynthesis

Intervention Type PROCEDURE

Osteosynthesis using a posterior plate

Osteosynthesis using an anterior plate

Group Type ACTIVE_COMPARATOR

DASH score

Intervention Type OTHER

Questionnaire asking about Disability of Arm, Shoulder and Hand

X-ray

Intervention Type PROCEDURE

postoperative x-rays at 6 weeks, 3, 6 and 12 months

Anterior osteosynthesis

Intervention Type PROCEDURE

Osteosynthesis using an anterior plate

Interventions

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DASH score

Questionnaire asking about Disability of Arm, Shoulder and Hand

Intervention Type OTHER

X-ray

postoperative x-rays at 6 weeks, 3, 6 and 12 months

Intervention Type PROCEDURE

posterior osteosynthesis

Osteosynthesis using a posterior plate

Intervention Type PROCEDURE

Anterior osteosynthesis

Osteosynthesis using an anterior plate

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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ALVERNHE LABATTUT 2016

Identifier Type: -

Identifier Source: org_study_id

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