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CompletedNCT00809861Updated May 29, 2014

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

An interventional study of volar locking plating and external immobilisation in Distal Radius Fractures, sponsored by Mackay Base Hospital. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-29.

Sponsored by Mackay Base Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Distal Radius Fractures
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 52 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

This is the only study on the registry with Mackay Base Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • distal radius fracture
  • age > 18

Exclusion criteria

Exclusion Criteria:

  • intellectual or mental impairment
  • \< 18 years of age
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    1

    volar locking plating of distal radius fractures

    Procedure: volar locking plating

  • Active comparator
    2

    Procedure: external immobilisation

Interventions

  • Procedurevolar locking plating

    open reduction and internal fixation

  • Procedureexternal immobilisation

    closed reduction and external fixation

06

What researchers measure

Primary outcomes

  1. 20% difference in DASH scores

    Time frame: twelve weeks

Secondary outcomes

  1. return to work

    Time frame: twelve weeks

07

Study locations

1 site
  • Mackay Base Hospital
    Mackay, Queensland 4740, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00809861
Lead sponsor
Mackay Base Hospital
Collaborators
James Cook University, Queensland, Australia
Responsible party
Dr. Herwig Drobetz (Director Orthopaedics, Mackay Base Hospital) — Principal investigator
First posted
Dec 17, 2008
Start date
Aug 2008
Primary completion
Dec 2013
Completion
Dec 2013
Last update
May 29, 2014

Study contacts

Herwig Drobetz, MD
principal investigator · Mackay Base Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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