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

NCT00809861 | Completed DMC

• 1 other identifier: DCDRS00407
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 20% difference in DASH scores

  twelve weeks

Secondary Outcomes (1)

• return to work

  twelve weeks

Study Arms (2)

1

ACTIVE COMPARATOR

volar locking plating of distal radius fractures

Procedure: volar locking plating

2

ACTIVE COMPARATOR

Procedure: external immobilisation

Interventions

volar locking plating PROCEDURE

open reduction and internal fixation

1

external immobilisation PROCEDURE

closed reduction and external fixation

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• distal radius fracture
• age \> 18

You may not qualify if:

• intellectual or mental impairment
• \< 18 years of age

Sponsors & Collaborators

• Mackay Base Hospital: lead
• James Cook University, Queensland, Australia: collaborator

Study Sites (1)

Mackay Base Hospital

Mackay, Queensland, 4740, Australia

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Herwig Drobetz, MD

  Mackay Base Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Orthopaedics

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

AU (1)