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

April 8, 2025 updated by: Lasse Rämö, Töölö Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Töölö Hospital, Helsinki University Central Hospital
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 years old patient who agrees to the consent to participation in this study
  • Unilateral dislocated humeral shaft fracture (dislocation over thickness of the bone cortex, fracture below the level of insertion of pectoralis major muscle and 5 cm above the olecranon fossa)
  • Randomization can be done within 10 days and operation within 14 days after the initial trauma
  • Patient is willing to participate all follow-up visits

Exclusion Criteria:

  • Bilateral humeral shaft fracture
  • A significant concomitant trauma of the same upper extremity that warrants operative treatment (fracture, tendon injury, soft tissue trauma)
  • Other fracture or abdominal/thoracal trauma that warrants operative treatment
  • Open fracture
  • Pathological fracture
  • Multi-trauma patient
  • Vascular injury
  • Plexus injury
  • Previous trauma in the same upper extremity that causes functional deficit
  • Trauma or condition that warrants use of walking aid (crutches, wheelchair etc)
  • Disease that affects significantly general condition of the patient
  • Significantly impaired ability to co-operate for any reason (substance abuse, mental disorder, dementia)
  • Unwilling to accept both treatment methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conservative treatment
Conservative treatment with functional brace and physiotherapy.
Device: Conservative treatment
Conservative treatment with functional brace.
Other: Physiotherapy
Physiotherapy is arranged to both groups at 3 and 9 wks.
Experimental: Operative treatment
Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.
Other: Physiotherapy
Physiotherapy is arranged to both groups at 3 and 9 wks.
Procedure: Operative treatment
Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Disabilities of the Arm, Shoulder and Hand Score (DASH)
Time Frame: at 12 months
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective assessment of the function of the upper extremity
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
Numerical Rating Scale (NRS) 0-10
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Constant Score
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Elbow ROM
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Health-related quality of life (15D)
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Complications
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups.
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Cost-effectiveness
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Subjective assessment of the function of the upper extremity
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
Likert Scale 1-7
6 wks, 3, 6, 12 mo, 2, 5, 10 years
Subjective assessment of the function of the elbow
Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
Numerical Rating Scale (NRS) 0-10
6 wks, 3, 6, 12 mo, 2, 5, 10 years
The Disabilities of the Arm, Shoulder and Hand Score (DASH)
Time Frame: at 6 wks, 3, 6 mo, 2, 5, 10 years
at 6 wks, 3, 6 mo, 2, 5, 10 years
Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10
Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
Percentage of patients with acceptable symptom state (PASS)
Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Töölö Hospital

Collaborators

Helsinki University Central Hospital
Tampere University Hospital
Finnish Institute for Health and Welfare

Investigators

  • Study Director: Mika Paavola, MD, PhD, Töölö Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2012

Primary Completion (Actual)

January 1, 2019

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

October 28, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimated)

November 1, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS-118/13/03/02/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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