Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures

This study has been completed.
Sponsor:
Collaborator:
James Cook University, Queensland, Australia
Information provided by (Responsible Party):
Dr. Herwig Drobetz, Mackay Base Hospital
ClinicalTrials.gov Identifier:
NCT00809861
First received: December 16, 2008
Last updated: May 28, 2014
Last verified: May 2014

December 16, 2008
May 28, 2014
August 2008
December 2013   (final data collection date for primary outcome measure)
20% difference in DASH scores [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
20 percent difference in mean DASH and PRWE
Complete list of historical versions of study NCT00809861 on ClinicalTrials.gov Archive Site
return to work [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
return to work
Not Provided
Not Provided
 
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures. A Randomised Controlled Prospective Study

Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed.

Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer).

Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation).

Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Distal Radius Fractures
  • Procedure: volar locking plating
    open reduction and internal fixation
  • Procedure: external immobilisation
    closed reduction and external fixation
  • Active Comparator: 1
    volar locking plating of distal radius fractures
    Intervention: Procedure: volar locking plating
  • Active Comparator: 2
    Intervention: Procedure: external immobilisation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • distal radius fracture
  • age > 18

Exclusion Criteria:

  • intellectual or mental impairment
  • < 18 years of age
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00809861
DCDRS00407
Yes
Dr. Herwig Drobetz, Mackay Base Hospital
Mackay Base Hospital
James Cook University, Queensland, Australia
Principal Investigator: Herwig Drobetz, MD Mackay Base Hospital
Mackay Base Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP