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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Töölö Hospital
Sponsor:
Collaborators:
Tampere University Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Lasse Ramo, Töölö Hospital
ClinicalTrials.gov Identifier:
NCT01719887
First received: October 28, 2012
Last updated: November 16, 2014
Last verified: November 2014

October 28, 2012
November 16, 2014
October 2012
October 2025   (final data collection date for primary outcome measure)
  • Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10 [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Pain at rest and in activity, Change in Numerical Rating Scale (NRS) 0-10 [ Time Frame: at 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Change in The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01719887 on ClinicalTrials.gov Archive Site
  • Subjective assessment of the function of the upper extremity [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Numerical Rating Scale (NRS) 0-10
  • Constant Score [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Elbow ROM [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Health-related quality of life (15D) [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: Yes ]
    Incidence of re-fracture, reoperation, infection and iatrogenic radial palsy is recorded and compared between study groups.
  • Union [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Time to union, non-union, malunion
  • Cost-effectiveness [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.
  • Subjective assessment of the function of the upper extremity [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Likert Scale 1-7
  • Subjective assessment of the function of the elbow [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Numerical Rating Scale (NRS) 0-10
  • The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 6 wks, 3, 6 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10 [ Time Frame: at 6 wks, 3, 6 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Subjective assessment of the function of the upper extremity [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Numerical Rating Scale (NRS) 0-10
  • Constant Score [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Elbow ROM [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Health-related quality of life (15D) [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: Yes ]
    Incidence of re-fracture, reoperation, infection and iatrogenic radial palsy is recorded and compared between study groups.
  • Union [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Time to union, non-union, malunion
  • Cost-effectiveness [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.
  • Subjective assessment of the function of the upper extremity [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Likert Scale 1-7
  • Subjective assessment of the function of the elbow [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
    Numerical Rating Scale (NRS) 0-10
Not Provided
Not Provided
 
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.

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 phycisian) 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Fracture
  • Device: Conservative treatment
    Conservative treatment with functional brace applied after 7 days of initial treatment with prefabricated cork splint.
  • 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.
  • Active Comparator: Conservative treatment
    Conservative treatment with functional brace and physiotherapy.
    Interventions:
    • Device: Conservative treatment
    • Other: Physiotherapy
  • Experimental: Operative treatment
    Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.
    Interventions:
    • Procedure: Operative treatment
    • Other: Physiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2025
October 2025   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lasse Rämö, MD +358505863300 lasse.ramo@iki.fi
Contact: Mika Paavola, MD, PhD +358504272481 mika.paavola@hus.fi
Finland
 
NCT01719887
HUS-118/13/03/02/2012
No
Lasse Ramo, Töölö Hospital
Töölö Hospital
  • Tampere University Hospital
  • National Institute for Health and Welfare, Finland
Study Director: Mika Paavola, MD, PhD Töölö Hospital
Töölö Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP