Fracture of Distal Radius Clinical Trial
— fradiusOfficial title:
Treatement of Extension Fractures of the Distal Radius : Prospective Randomized Postoperative Comparison Between Trans-styloid and Intrafical Pinning on the One Side and Volar Fixed-angle Plating on the Other Side.
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Department of Bone Surgery | Limoges, |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |