Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
This study is currently recruiting participants.
Verified December 2011 by Danderyd Hospital
Sponsor:
Danderyd Hospital
Information provided by (Responsible Party):
Maria Wilcke, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01268397
First received: December 29, 2010
Last updated: December 9, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.
| Condition | Intervention |
|---|---|
|
Fracture of the Distal Radius Wrist Fracture |
Procedure: open reduction and internal fixation with a volar plate Procedure: closed reduction and plaster treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment. |
Resource links provided by NLM:
Further study details as provided by Danderyd Hospital:
Primary Outcome Measures:
- patient-perceived disability measured by the PRWE and DASH questionnaires [ Time Frame: one year after wrist fracture ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- impairments (grip strength and range of motion compared with the uninjured wrist) [ Time Frame: one year after wrist fracture ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: open reduction and internal fixation with a volar plate |
Procedure: open reduction and internal fixation with a volar plate
flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
Other Name: plate: Königsee or Aculoc from Swmac, Sweden
|
| Active Comparator: closed reduction and plaster treatment |
Procedure: closed reduction and plaster treatment
closed reduction, below elbow plaster cast for 5 week
|
Detailed Description:
We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).
Exclusion Criteria:
- Previous displaced fracture of the distal radius.
- Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268397
Contacts
| Contact: Maria Wilcke, MD | +46708294613 | maria.wilcke@ds.se |
| Contact: Kristin Olsson, MD | +4686555000 | kristin.olsson@ds.se |
Locations
| Sweden | |
| Division of Orthopaedics Danderyd Hospital | Recruiting |
| Stockholm, Sweden, S-18288 | |
| Contact: Maria Wilcke, ND +46708294613 maria.wilcke@ds.se | |
| Contact: Kristin Olsson, MD +4686555000 kristin.olsson@ds.se | |
| Principal Investigator: Per Adolpson, MD, PhD | |
Sponsors and Collaborators
Danderyd Hospital
Investigators
| Study Director: | Per Y Adolphson, MD, PhD | Karolinska Institute at Danderyd Hospital |
More Information
No publications provided
| Responsible Party: | Maria Wilcke, MD, Danderyd Hospital |
| ClinicalTrials.gov Identifier: | NCT01268397 History of Changes |
| Other Study ID Numbers: | Wilcke-02 |
| Study First Received: | December 29, 2010 |
| Last Updated: | December 9, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Danderyd Hospital:
|
elderly wrist fracture fracture of the distal radius volar plate plaster cast |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013