Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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 August 2016 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: August 19, 2016
Last verified: August 2016
History of Changes
  Purpose

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 Intervention
Fracture
 Device: Conservative treatment
Procedure: Operative treatment
Other: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Töölö Hospital:

Primary Outcome Measures:
  • The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary 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 ]
    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, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]
  • Percentage of recovered patients [ Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]

    Recovery is considered achieved, when following terms are met:

    1. Pain-NRS (0-10) at rest is 1 or less. AND
    2. Pain-NRS (0-10) in activities is 3 or less. AND
    3. Patient's general satisfaction of upper extremity condition is 7-10 on 0-10 NRS.

  • Percentage of patients with poor recovery [ Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years ] [ Designated as safety issue: No ]

    The result is considered poor, when following terms are met:

    1. Pain-NRS (0-10) at rest is 5 or more. OR
    2. Pain-NRS (0-10) in activities is 6 or more. OR
    3. Patient's general satisfaction of upper extremity condition is 0-3 on 0-10 NRS.
Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2025
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719887

Contacts
Contact: Lasse Rämö, MD +358505863300 lasse.ramo@iki.fi
Contact: Mika Paavola, MD, PhD +358504272481 mika.paavola@hus.fi

Locations
Finland
Töölö Hospital, Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Jarkko Pajarinen, MD, PhD    +358504271930    jarkko.pajarinen@hus.fi   
Contact: Mika Paavola, MD, PhD    +358504272481    mika.paavola@hus.fi   
Principal Investigator: Lasse Rämö, MD         
Sub-Investigator: Mika Paavola, MD, PhD         
Sub-Investigator: Jarkko Pajarinen, MD, PhD         
Sub-Investigator: Jan-Magnus Björkenheim, MD, PhD         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Vesa Lepola, MD, PhD       vesa.lepola@pshp.fi   
Principal Investigator: Vesa Lepola, MD, PhD         
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

Responsible Party: Lasse Ramo, MD, Töölö Hospital
ClinicalTrials.gov Identifier: NCT01719887     History of Changes
Other Study ID Numbers: HUS-118/13/03/02/2012 
Study First Received: October 28, 2012
Last Updated: August 19, 2016
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 29, 2016