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

Sponsor

Töölö Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01719887

Collaborator

Helsinki University Central Hospital (Other), Tampere University Hospital (Other), Finnish Institute for Health and Welfare (Other)

Enrollment

Locations

Arms

181.9

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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:

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 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.

Condition or Disease	Intervention/Treatment	Phase
Fracture	Device: Conservative treatment Procedure: Operative treatment Other: Physiotherapy	N/A

Study Design

Study Type:

Interventional

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 :

Nov 4, 2012

Actual Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conservative treatment Conservative treatment with functional brace and physiotherapy.	Device: Conservative treatment Conservative treatment with functional brace. 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.

Arm

Intervention/Treatment

Active Comparator: Conservative treatment

Conservative treatment with functional brace and physiotherapy.

Device: Conservative treatment

Conservative treatment with functional brace.

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

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective assessment of the function of the upper extremity [6 wks, 3, 6, 12 mo, 2, 5, 10 years]
Numerical Rating Scale (NRS) 0-10
Constant Score [6 wks, 3, 6, 12 mo, 2, 5, 10 years]
Elbow ROM [6 wks, 3, 6, 12 mo, 2, 5, 10 years]
Health-related quality of life (15D) [6 wks, 3, 6, 12 mo, 2, 5, 10 years]
Complications [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 [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 [6 wks, 3, 6, 12 mo, 2, 5, 10 years]
Likert Scale 1-7
Subjective assessment of the function of the elbow [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) [at 6 wks, 3, 6 mo, 2, 5, 10 years]
Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10 [at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years]
Percentage of patients with acceptable symptom state (PASS) [at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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