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

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01719887
• Other study ID #: HUS-118/13/03/02/2012
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2012
• Est. completion date: January 2028

Study information

• Verified date: November 2023
• Source: Töölö Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: January 2028
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Device:
• Conservative treatment
Conservative treatment with functional brace.

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.

Locations

Country	Name	City	State
Finland	Töölö Hospital, Helsinki University Central Hospital	Helsinki
Finland	Tampere University Hospital	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
Töölö Hospital	Finnish Institute for Health and Welfare, Helsinki University Central Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (3)

Ramo L, Paavola M, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Jarvinen TLN, Taimela S; FISH Investigators. Outcomes With Surgery vs Functional Bracing for Patients With Closed, Displaced Humeral Shaft Fractures and the Need for Secondary Surgery: A Pres — View Citation

Ramo L, Sumrein BO, Lepola V, Lahdeoja T, Ranstam J, Paavola M, Jarvinen T, Taimela S; FISH Investigators. Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clin — View Citation

Ramo L, Taimela S, Lepola V, Malmivaara A, Lahdeoja T, Paavola M. Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort. BMJ Open. 2017 Jul 9;7(7):e014076. doi: 10.1136/bmjopen-2016-014076. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Disabilities of the Arm, Shoulder and Hand Score (DASH)		at 12 months
Secondary	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
Secondary	Constant Score		6 wks, 3, 6, 12 mo, 2, 5, 10 years
Secondary	Elbow ROM		6 wks, 3, 6, 12 mo, 2, 5, 10 years
Secondary	Health-related quality of life (15D)		6 wks, 3, 6, 12 mo, 2, 5, 10 years
Secondary	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
Secondary	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
Secondary	Subjective assessment of the function of the upper extremity	Likert Scale 1-7	6 wks, 3, 6, 12 mo, 2, 5, 10 years
Secondary	Subjective assessment of the function of the elbow	Numerical Rating Scale (NRS) 0-10	6 wks, 3, 6, 12 mo, 2, 5, 10 years
Secondary	The Disabilities of the Arm, Shoulder and Hand Score (DASH)		at 6 wks, 3, 6 mo, 2, 5, 10 years
Secondary	Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10		at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
Secondary	Percentage of patients with acceptable symptom state (PASS)		at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years

External Links

•   1-year results in JAMA
•   2-year results in JAMA Surgery
•   Protocol article in BMJ Open