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

This study is currently recruiting participants.

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Contacts and Locations

Verified May 2017 by Lasse Ramo, 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: May 28, 2017

Last verified: May 2017

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:

Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate.
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 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.

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Lasse Ramo, Töölö Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
Constant Score [ Time Frame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years ]
Elbow ROM [ Time Frame: 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 ]
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.
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.
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
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
The Disabilities of the Arm, Shoulder and Hand Score (DASH) [ Time Frame: 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 ]
Percentage of patients with acceptable symptom state (PASS) [ Time Frame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years ]


Estimated Enrollment:	80
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)
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

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: Mika Paavola, MD, PhD +358504272481 mika.paavola@hus.fi
Principal Investigator: Lasse Rämö, MD
Sub-Investigator: Mika Paavola, MD, PhD
Sub-Investigator: Tuomas Lähdeoja, MD
Sub-Investigator: Mikko Salmela, MD
Tampere University Hospital	Recruiting
Tampere, Finland
Contact: Bakir Sumrein, MD bakir.sumrein@pshp.fi
Principal Investigator: Bakir Sumrein, MD

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:	May 28, 2017

Keywords provided by Lasse Ramo, Töölö Hospital:


humerus humeral shaft	diaphysis fracture RCT

Additional relevant MeSH terms:


Fractures, Bone Wounds and Injuries

ClinicalTrials.gov processed this record on August 23, 2017

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