A prospective multi-center cohort study of acute non-displaced fractures of the scaphoid: operative versus non-operative treatment [NCT00205985]

Boris M Pfeiffer, Matthias Nübling, Hartmut R Siebert, Michael Schädel-Höpfner, Boris M Pfeiffer, Matthias Nübling, Hartmut R Siebert, Michael Schädel-Höpfner

Abstract

Background: Acute scaphoid fractures are common in active adults and do lead to reasonable time lost to work. One important goal of treatment is early return to work or sport. On this background, the adequate treatment of non-displaced acute scaphoid fractures is still under discussion. The aim of this study is to compare time to return to previous activity level comparing surgical versus non-surgical treatment of non-displaced acute scaphoid fractures.

Methods/design: The study is designed as a non-randomized multiple center cohort study including 12 sites in Germany and Austria. The inclusion period is planned to be 12 months with a follow up of 6 months. Allocation to operative or non-operative treatment is chosen by the patient together with his treating surgeon. The primary outcome is time to return to previous activity level adapted for loading of the wrist in daily life as measured by a newly developed questionnaire (PLDL-wrist). Factors identified a priori to be associated with the outcome, e.g., poverty status, age, education, smoking status, gender, and occupation, are measured to ensure adequate control for their potential confounding effects.

Discussion: The rationale and the design of a multiple center cohort study are presented. As it is not considered feasible to randomize patients in this study, potential confounding effects need to be controlled adequately.

Trial registration: ClinicalTrials.gov NCT00205985.

Figures

Figure 1
Figure 1
Number of publications of studies with RTW as outcome parameter. Pubmed-search from 1966 – 12/2003 using the search strategies: (1) [('return' OR 'day* lost' OR 'disability') AND 'work'] OR 'sick leave'; Limit: 'Clinical Trial' (2) {[('return' OR 'day* lost' OR 'disability') AND 'work'] OR 'sick leave'} AND 'Orthopaedic Procedures [mh]'. The abstracts of the retrieved publications were scanned to identify clinical studies using either 'return to work' or 'time of sick leave' as primary or secondary outcome. The found studies were categorised into one of the following 6 groups: 'Hand', 'Spine', 'Long Bone', 'Foot and Ankle', 'Knee' or 'Neck and Shoulder'.
Figure 2
Figure 2
Follow up procedures. At 6-weeks, 3-months and 6-months, the determination of the outcomes is done during in-house visits of the patients in the clinic. At 3-weeks, 9-weeks and 15-weeks, the QAS and PLDL-wrist questionnaires are retrieved via telephone interview.

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