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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00809861

Registration number

NCT00809861

Ethics application status

Date submitted

16/12/2008

Date registered

17/12/2008

Date last updated

29/05/2014

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

DCDRS00407

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Distal Radius Fractures

Condition category

Condition code

Injuries and Accidents

Fractures

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Surgery - volar locking plating
Treatment: Surgery - external immobilisation

Active comparator: 1 - volar locking plating of distal radius fractures

Active comparator: 2 -

Treatment: Surgery: volar locking plating
open reduction and internal fixation

Treatment: Surgery: external immobilisation
closed reduction and external fixation

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

20% difference in DASH scores

Timepoint [1]

twelve weeks

Secondary outcome [1]

return to work

Timepoint [1]

twelve weeks

Eligibility

Key inclusion criteria

* distal radius fracture
* age > 18

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* intellectual or mental impairment
* < 18 years of age

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/08/2008

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/12/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mackay Base Hospital - Mackay

Recruitment postcode(s) [1]

4740 - Mackay

Funding & Sponsors

Primary sponsor type

Other

Name

Mackay Base Hospital

Address

Country

Other collaborator category [1]

Other

Name [1]

James Cook University, Queensland, Australia

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT00809861

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Herwig Drobetz, MD

Address

Mackay Base Hospital

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00809861

Trial Review

Did you know?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00809861