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Humeral Shaft Fractures: Measuring Recovery after Operative versus Non-operative Treatment (HUMMER): A multicenter comparative observational study.

Completed
Conditions
Humeral shaft fracture
Registration Number
NL-OMON23527
Lead Sponsor
Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of SurgeryErasmus Medical Center, Medical Research Ethics Committee (MREC)
Brief Summary

Mahabier KC, Van Lieshout EMM, Bolhuis HW, Bos PK, Bronkhorst MWGA, Bruijninckx MMM, De Haan J, Deenik AR, Dwars BJ, Eversdijk MG, Goslings JC, Haverlag R, Heetveld MJ, Kerver AJH, Kolkman KA, Leenhouts PA, Meylaerts SAG, Onstenk R, Poeze M, Poolman RP, Punt BJ, Roerdink WH, Roukema GR, Tanka AKF, Sintenie JB, Soesman NMR, Ten Holder EJT, Van der Elst M, Van der Heijden MHWM, Van der Linden FM, Van der Zwaal P, Van Dijk JP, Van Jonbergen HPW, Verleisdonk EJMM, Vroemen JPAM, Waleboer M, Wittich P, Zuidema WP, Polinder S, Verhofstad MHJ, Den Hartog D. HUMeral Shaft Fractures: MEasuring Recovery after Operative versus Non-operative Treatment (HUMMER): a multicenter comparative observational study. BMC Musculoskelet Disord 2014 Feb 11;15(1):39.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
400
Inclusion Criteria

1. Adult men or women aged 18 years and older (with no upper age limit);

2. A fracture of the humeral shaft, AO class 12A or 12B (confirmed on X-ray);

Exclusion Criteria

1. Polytraumatized patients affecting treatment and rehabilitation of the affected arm;

2. Patients treated with an external fixator;

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
DASH (Disabilities of the Arm, Shoulder, and Hand) score.
Secondary Outcome Measures
NameTimeMethod
1. Constant score;<br /><br>2. Pain level (VAS);<br /><br>3. Range of Motion of the shoulder and elbow joints;<br /><br>4. Rate of complications;<br /><br>5. Rate of secondary interventions;<br /><br>6. Time to resumption of work and activities of daily living;<br /><br>7. Health-related quality of life (SF-36 and EQ-5D);<br /><br>8. Costs;<br /><br>9. Cost-effectiveness.
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