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TerminatedNCT03259906PAPPOUpdated Feb 22, 2024

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

An interventional study of DASH score and X-ray in Distal Intra-articular Radius Fracture With a Dorsal Tilt, sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of performance
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Distal Intra-articular Radius Fracture With a Dorsal Tilt
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Osteosynthesis using a posterior plate

    Other: DASH score · Procedure: X-ray · Procedure: posterior osteosynthesis

  • Active comparator
    Osteosynthesis using an anterior plate

    Other: DASH score · Procedure: X-ray · Procedure: Anterior osteosynthesis

Interventions

  • OtherDASH score

    Questionnaire asking about Disability of Arm, Shoulder and Hand

  • ProcedureX-ray

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

  • Procedureposterior osteosynthesis

    Osteosynthesis using a posterior plate

  • ProcedureAnterior osteosynthesis

    Osteosynthesis using an anterior plate

05

What researchers measure

Primary outcomes

  1. Evaluation of functional recovery using the DASH questionnaire

    Time frame: 6 months

06

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, 21000, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03259906
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Jan 2017
Primary completion
Jul 4, 2018
Completion
Jul 4, 2018
Last update
Feb 22, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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