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Clinical Trial

Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial

NCT: NCT01719887 · ACTIVE_NOT_RECRUITING

NCT IDNCT01719887
StatusACTIVE_NOT_RECRUITING
Start Date2012-11-04
Completion2028-01
SponsorTöölö Hospital (OTHER)
First posted
Last updated

Brief Summary

Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures. These fractures have historically been treated mainly conservatively with good results. Recent development in fracture treatment and findings that certain fracture types are more prone to non-union and bracing-related functional problems of adjacent joints are somewhat common have caused increasing interest in treating these fractures surgically. Return to activities is also considered to be quicker among surgically treated patients. The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who are willing to participate in the study after informed consent are randomly assigned to two different treatment methods: 1. Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate. 2. Conservative treatment with functional bracing The randomization is done using blocked randomization (block sizes are not known by the enrolling or assigning physician) and stratification is done according to fracture type (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no palsy). Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and clinical and radiological assessments are made. The physiotherapist doing objective functional measurements is blinded to treatment method. Both study groups receive physiotherapy after the initial treatment.

Frequently Asked Questions

What is Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial?

Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial is a clinical trial registered under NCT01719887. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT01719887?

The current status of NCT01719887 (Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial) is: ACTIVE_NOT_RECRUITING.

When did Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial start?

Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial started on 2012-11-04.

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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