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NCT Number: NCT01719887

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Töölö Hospital, Helsinki University Central Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative treatment

Device

Conservative treatment with functional brace.

Operative treatment

Procedure

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

Physiotherapy

Other

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

Primary outcomes

  1. The Disabilities of the Arm, Shoulder and Hand Score (DASH)

    Time frame: at 12 months

Secondary outcomes

  1. 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

  2. Constant Score

    Time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years

  3. Elbow ROM

    Time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years

  4. Health-related quality of life (15D)

    Time frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years

  5. 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. 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.

  7. 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

  8. 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

  9. The Disabilities of the Arm, Shoulder and Hand Score (DASH)

    Time frame: at 6 wks, 3, 6 mo, 2, 5, 10 years

  10. 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

  11. Percentage of patients with acceptable symptom state (PASS)

    Time frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years

Sponsors and collaborators

Lead sponsor

Töölö Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2028
First posted
Nov 1, 2012
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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