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

Distal Radius Fractures Clinical Trial

Official title:

Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures. A Randomised Controlled Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809861
• Other study ID #: DCDRS00407
• Status: Completed
• Phase: N/A
• First received: December 16, 2008
• Last updated: May 28, 2014
• Start date: August 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Mackay Base Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• distal radius fracture

• age > 18

Exclusion Criteria:

• intellectual or mental impairment

• < 18 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• volar locking plating
open reduction and internal fixation
• external immobilisation
closed reduction and external fixation

Locations

Country	Name	City	State
Australia	Mackay Base Hospital	Mackay	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Base Hospital	James Cook University, Queensland, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% difference in DASH scores		twelve weeks	No
Secondary	return to work		twelve weeks	No