Treatement of Extension Fractures of the Distal Radius

NCT00492492 | Completed DMC

• 1 other identifier: I06029
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of extension fractures of the distal radius : prospective randomized postoperative comparison between trans-styloid and intrafocal pinning on the one side and volar fixed-angle plating on the other side.

Conditions

Fracture of Distal Radius

Keywords

radius,; pinning,; fixed-angle plate,; quick-DASH,; HERZBERG-score.

Outcome Measures

Primary Outcomes (1)

• The main judging criterion will lay on an X-ray assessment of the distal radius, we will try to find a loss of reduction.

  3 months

Secondary Outcomes (1)

• The secondary criteria will lay on fonctional scores (quickDASH and Herzberg score), as well as on post-operative X-ray assessments in order to compare post-operative reduction of the distal radius fracture.

  6 weeks, 3 months, 6 months

Study Arms (2)

trans-styloid and intrafocal pinning on the one side

OTHER

trans-styloid and intrafocal pinning on the one side

Procedure: trans-styloid and intrafocal pinning on the one side

volar fixed-angle plating on the other side

OTHER

volar fixed-angle plating on the other side

Procedure: volar fixed-angle plating on the other side

Interventions

trans-styloid and intrafocal pinning on the one side PROCEDURE

trans-styloid and intrafocal pinning on the one side

volar fixed-angle plating on the other side PROCEDURE

volar fixed-angle plating on the other side

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient who is affiliated to the NHS (National Health Service)
• patient who has officially given his consent
• on over 50 year old patient
• Patient with an extension fracture of the distal radius
• patient who is in no condition to express his consent

You may not qualify if:

• patient who is under the protection of justice
• Patient with an open fracture
• Patient with an flexion fracture of the distal radius
• Patient with a metastasis localized in the distal radius
• traumatised patient
• patient who is liable not to profit by medical follow-up in Limoges hospital after he has been operated on
• A pregnant woman / a parturient / a breast-feeding mother
• patient who is serving a sentence .
• patient sent to hospital without his consent

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Department of Bone Surgery

Limoges, 87000, France

Location

Related Publications (1)

• Marcheix PS, Dotzis A, Benko PE, Siegler J, Arnaud JP, Charissoux JL. Extension fractures of the distal radius in patients older than 50: a prospective randomized study comparing fixation using mixed pins or a palmar fixed-angle plate. J Hand Surg Eur Vol. 2010 Oct;35(8):646-51. doi: 10.1177/1753193410364179. Epub 2010 Mar 17.

  PMID: 20237186 BACKGROUND

Study Officials

• Jean-Louis CHARISSOUX, MD

  CHU LIMOGES

  PRINCIPAL INVESTIGATOR

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: June 26, 2007
• First Posted: June 27, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

FR (1)