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

NCT03259906 | Terminated

• 1 other identifier: ALVERNHE LABATTUT 2016
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 45 years.

Conditions

Distal Intra-articular Radius Fracture With a Dorsal Tilt

Outcome Measures

Primary Outcomes (1)

• Evaluation of functional recovery using the DASH questionnaire

  6 months

Study Arms (2)

Osteosynthesis using a posterior plate

ACTIVE COMPARATOR

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

Osteosynthesis using an anterior plate

ACTIVE COMPARATOR

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

Interventions

DASH score OTHER

Questionnaire asking about Disability of Arm, Shoulder and Hand

Osteosynthesis using a posterior plate; Osteosynthesis using an anterior plate

X-ray PROCEDURE

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

Osteosynthesis using a posterior plate; Osteosynthesis using an anterior plate

posterior osteosynthesis PROCEDURE

Osteosynthesis using a posterior plate

Osteosynthesis using a posterior plate

Anterior osteosynthesis PROCEDURE

Osteosynthesis using an anterior plate

Osteosynthesis using an anterior plate

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 24, 2017
• Study Start: January 1, 2017
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

FR (1)