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

February 21, 2024 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Osteosynthesis using a posterior plate
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
Procedure: posterior osteosynthesis
Osteosynthesis using a posterior plate
Active Comparator: Osteosynthesis using an anterior plate
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
Procedure: Anterior osteosynthesis
Osteosynthesis using an anterior plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of functional recovery using the DASH questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 4, 2018

Study Completion (Actual)

July 4, 2018

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALVERNHE LABATTUT 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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