Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01268397
Other study ID # Wilcke-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2009
Est. completion date December 2019

Study information

Verified date April 2018
Source Danderyd Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date December 2019
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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).

Study Design


Intervention

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
closed reduction and plaster treatment
closed reduction, below elbow plaster cast, semicircular for 5 week

Locations

Country Name City State
Sweden Division of Orthopaedics Danderyd Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Danderyd Hospital Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient-perceived disability measured by the PRWE and DASH questionnaires one year after wrist fracture
Secondary impairments (grip strength and range of motion compared with the uninjured wrist) one year after wrist fracture
See also
  Status Clinical Trial Phase
Completed NCT04046744 - Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery. N/A
Completed NCT05883410 - The Effect of Two Different Protocol in Wrist Joint Limitation After Distal Radius End Fractures N/A
Terminated NCT02464280 - Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT
Not yet recruiting NCT03937492 - EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY N/A
Recruiting NCT05943574 - PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
Active, not recruiting NCT04623346 - Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
Completed NCT02802358 - Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall N/A
Completed NCT03649542 - The Effects of Fluidotherapy® Exercise N/A
Not yet recruiting NCT03316768 - Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production
Completed NCT02015468 - The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating N/A
Active, not recruiting NCT06067074 - Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture N/A
Terminated NCT01293227 - WRx Distal Radius Wrist Fracture Study N/A
Completed NCT03126474 - Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study
Active, not recruiting NCT04716309 - Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP). N/A
Completed NCT02693288 - Comparing Efficacity of Analgesia Between Ultrasound-guided Nerve Block and Local Infiltration After Wrist Fracture Surgery N/A
Recruiting NCT05183477 - Fast Track for Wrist and Scaphoid Fractures N/A
Withdrawn NCT04527588 - Italian Translation of the Michigan Hand Outcomes Questionnaire
Completed NCT03555929 - Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine. Phase 3
Recruiting NCT04820114 - Proprioception and Multi Sensory Training After DRF N/A