Clinical trial NCT00809861: Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures
Official title: Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures. A Randomised Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: Mackay Base Hospital
Sponsor class: OTHER
Collaborators: name: James Cook University, Queensland, Australia
First posted: 2008-12-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* distal radius fracture
* age \> 18

Exclusion Criteria:

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

Primary outcomes:
measure: 20% difference in DASH scores
timeFrame: twelve weeks
Secondary outcomes:
measure: return to work
timeFrame: twelve weeks
Other outcomes:
Locations:
city: Mackay
country: Australia
facility: Mackay Base Hospital
state: Queensland
Study officials:
affiliation: Mackay Base Hospital
name: Herwig Drobetz, MD
role: PRINCIPAL_INVESTIGATOR
References: