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

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ClinicalTrials.gov Identifier: NCT01719887
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Tampere University Hospital
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Lasse Ramo, Töölö Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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.


Condition or disease Intervention/treatment Phase
Fracture Device: Conservative treatment Procedure: Operative treatment Other: Physiotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial.
Actual Study Start Date : October 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Conservative treatment
Conservative treatment with functional brace and physiotherapy.
 Device: Conservative treatment
Conservative treatment with functional brace applied after 7 days of initial treatment with prefabricated cork splint.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719887


Locations
Finland
Töölö Hospital, Helsinki University Central Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Töölö Hospital
Tampere University Hospital
National Institute for Health and Welfare, Finland
Investigators
Study Director: Mika Paavola, MD, PhD Töölö Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Protocol article in BMJ Open  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Lasse Ramo, MD, Töölö Hospital
ClinicalTrials.gov Identifier: NCT01719887     History of Changes
Other Study ID Numbers: HUS-118/13/03/02/2012
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Lasse Ramo, Töölö Hospital:
humerus
humeral
shaft
 diaphysis
fracture
RCT

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries