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

NCT ID: NCT00809861

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Distal Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

volar locking plating of distal radius fractures

Group Type: ACTIVE_COMPARATOR

volar locking plating

Intervention Type: PROCEDURE

open reduction and internal fixation

2

Group Type: ACTIVE_COMPARATOR

external immobilisation

Intervention Type: PROCEDURE

closed reduction and external fixation

Interventions

volar locking plating

open reduction and internal fixation

Intervention Type: PROCEDURE

external immobilisation

closed reduction and external fixation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• distal radius fracture
• age > 18

Exclusion Criteria

• intellectual or mental impairment
• < 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Cook University, Queensland, Australia

OTHER

Sponsor Role: collaborator

Mackay Base Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Herwig Drobetz

Director Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herwig Drobetz, MD

Role: PRINCIPAL_INVESTIGATOR

Mackay Base Hospital

Locations

Mackay Base Hospital

Mackay, Queensland, Australia

Countries

Australia

Other Identifiers

DCDRS00407

Identifier Type: -

Identifier Source: org_study_id