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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fracture

Intervention / Treatment
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* Device: Conservative treatment
* Procedure: Operative treatment
* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative treatment<br>Conservative treatment with functional brace and physiotherapy. | Device: Conservative treatment<br>* Conservative treatment with functional brace.<br>Other: Physiotherapy<br>* Physiotherapy is arranged to both groups at 3 and 9 wks.<br>|
| Experimental: Operative treatment<br>Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks. | Procedure: Operative treatment<br>* Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.<br>Other: Physiotherapy<br>* Physiotherapy is arranged to both groups at 3 and 9 wks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disabilities of the Arm, Shoulder and Hand Score (DASH) |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective assessment of the function of the upper extremity | Numerical Rating Scale (NRS) 0-10 | 6 wks, 3, 6, 12 mo, 2, 5, 10 years | 
| 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 | Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups. | 6 wks, 3, 6, 12 mo, 2, 5, 10 years | 
| Cost-effectiveness | Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures. | 6 wks, 3, 6, 12 mo, 2, 5, 10 years | 
| Subjective assessment of the function of the upper extremity | Likert Scale 1-7 | 6 wks, 3, 6, 12 mo, 2, 5, 10 years | 
| Subjective assessment of the function of the elbow | Numerical Rating Scale (NRS) 0-10 | 6 wks, 3, 6, 12 mo, 2, 5, 10 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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humerus, humeral, shaft, diaphysis, fracture, RCT