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

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ClinicalTrials.gov Identifier: NCT03259906
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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 60 years.


Condition or disease Intervention/treatment Phase
Distal Intra-articular Radius Fracture With a Dorsal Tilt Other: DASH score Procedure: X-ray Procedure: posterior osteosynthesis Procedure: Anterior osteosynthesis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Evaluation of functional recovery using the DASH questionnaire [ Time Frame: 6 months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have provided written informed consent
  • Patients older than 60 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259906


Contacts
Contact: Ludovic LABATTUT, MD 03 80 29 33 74 Ludovic.LABATTUT@chu-dijon.fr

Locations
France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Ludovic LABATTUT    03 80 29 33 74    Ludovic.LABATTUT@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03259906     History of Changes
Other Study ID Numbers: ALVERNHE LABATTUT 2016
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries