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

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.

Conditions

• Fracture

Interventions

DEVICE

Conservative treatment

Conservative treatment with functional brace.

PROCEDURE

Operative treatment

Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.

OTHER

Physiotherapy

Physiotherapy is arranged to both groups at 3 and 9 wks.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Finnish Institute for Health and Welfare

  collaborator OTHER_GOV

• Töölö Hospital

  lead OTHER

Principal Investigators

• Mika Paavola, MD, PhD · Töölö Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-04

Primary Completion

2019-01-31

Completion

2028-01-31

Countries

• Finland

Study Locations