Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate (PAPPO)
Primary Purpose
Distal Intra-articular Radius Fracture With a Dorsal Tilt
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DASH score
X-ray
posterior osteosynthesis
Anterior osteosynthesis
Sponsored by
About this trial
This is an interventional treatment trial for Distal Intra-articular Radius Fracture With a Dorsal Tilt
Eligibility 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
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Osteosynthesis using a posterior plate
Osteosynthesis using an anterior plate
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of functional recovery using the DASH questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03259906
First Posted
August 21, 2017
Last Updated
August 23, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03259906
Brief Title
Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Intra-articular Radius Fracture With a Dorsal Tilt
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteosynthesis using a posterior plate
Arm Type
Active Comparator
Arm Title
Osteosynthesis using an anterior plate
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
DASH score
Intervention Description
Questionnaire asking about Disability of Arm, Shoulder and Hand
Intervention Type
Procedure
Intervention Name(s)
X-ray
Intervention Description
postoperative x-rays at 6 weeks, 3, 6 and 12 months
Intervention Type
Procedure
Intervention Name(s)
posterior osteosynthesis
Intervention Description
Osteosynthesis using a posterior plate
Intervention Type
Procedure
Intervention Name(s)
Anterior osteosynthesis
Intervention Description
Osteosynthesis using an anterior plate
Primary Outcome Measure Information:
Title
Evaluation of functional recovery using the DASH questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ludovic LABATTUT, MD
Phone
03 80 29 33 74
Email
Ludovic.LABATTUT@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic LABATTUT
Phone
03 80 29 33 74
Email
Ludovic.LABATTUT@chu-dijon.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
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