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


CONCLUSIONS
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.
Pfeiffer
Boris M
BM
AO Clinical Investigation and Documentation, Clavadelerstrasse 8, CH-7270 Davos Platz, Switzerland. boris.pfeiffer@aofoundation.org
Nübling
Matthias
M
Siebert
Hartmut R
HR
Schädel-Höpfner
Michael
M
D000041:Absenteeism; D000208:Acute Disease; D000328:Adult; D001317:Austria; D001863:Bone Screws; D002370:Casts, Surgical; D015331:Cohort Studies; D015986:Confounding Factors, Epidemiologic; D005593:Fracture Fixation, Internal / Q000706:statistics & numerical data; D017102:Fracture Healing; D050723:Fractures, Bone / Q000534:rehabilitation / Q000601:surgery / Q000628:therapy*; D005858:Germany; D018737:Hand Strength; D006801:Humans; D007103:Immobilization / Q000706:statistics & numerical data; D016268:Internal Fixators; D010147:Pain Measurement; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D016059:Range of Motion, Articular; D020127:Recovery of Function; D012107:Research Design; D018401:Sample Size; D021361:Scaphoid Bone / Q000293:injuries* / Q000601:surgery; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome