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
  Purpose

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.


Condition Intervention
Distal Radius Fractures
Procedure: volar locking plating
Procedure: external immobilisation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures. A Randomised Controlled Prospective Study

Resource links provided by NLM:


Further study details as provided by Mackay Base Hospital:

Primary Outcome Measures:
  • 20% difference in DASH scores [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • return to work [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: August 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
volar locking plating of distal radius fractures
Procedure: volar locking plating
open reduction and internal fixation
Active Comparator: 2 Procedure: external immobilisation
closed reduction and external fixation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • distal radius fracture
  • age > 18

Exclusion Criteria:

  • intellectual or mental impairment
  • < 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809861

Locations
Australia, Queensland
Mackay Base Hospital
Mackay, Queensland, Australia, 4740
Sponsors and Collaborators
Mackay Base Hospital
James Cook University, Queensland, Australia
Investigators
Principal Investigator: Herwig Drobetz, MD Mackay Base Hospital
  More Information

No publications provided

Responsible Party: Dr. Herwig Drobetz, Director Orthopaedics, Mackay Base Hospital
ClinicalTrials.gov Identifier: NCT00809861     History of Changes
Other Study ID Numbers: DCDRS00407
Study First Received: December 16, 2008
Last Updated: May 28, 2014
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 08, 2014