Clinical trial NCT01719887: Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial
Official title: Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fracture
Keywords: humerus
humeral
shaft
diaphysis
fracture
RCT
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Tampere University Hospital
name: Finnish Institute for Health and Welfare
First posted: 2012-11-01
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


Eligibility 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

Primary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand Score (DASH)
timeFrame: at 12 months
Secondary outcomes:
measure: Subjective assessment of the function of the upper extremity
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Constant Score
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Elbow ROM
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Health-related quality of life (15D)
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Complications
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Cost-effectiveness
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Subjective assessment of the function of the upper extremity
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: Subjective assessment of the function of the elbow
timeFrame: 6 wks, 3, 6, 12 mo, 2, 5, 10 years
measure: The Disabilities of the Arm, Shoulder and Hand Score (DASH)
timeFrame: at 6 wks, 3, 6 mo, 2, 5, 10 years
measure: Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10
timeFrame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
measure: Percentage of patients with acceptable symptom state (PASS)
timeFrame: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital, Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Töölö Hospital
name: Mika Paavola, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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 Clinical Trial. JAMA. 2020 May 12;323(18):1792-1801. doi: 10.1001/jama.2020.3182.
citation: 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 Prespecified Secondary Analysis of the FISH Randomized Clinical Trial. JAMA Surg. 2021 Apr 14;156(6):1-9. doi: 10.1001/jamasurg.2021.0906. Online ahead of print.
citation: Ramo L, Ibounig T, Sumrein BO, Lepola V, Paavola M, Taimela S, Jarvinen TLN; FISH Investigators. Five-Year Follow-Up of Surgery vs Functional Bracing for Closed Displaced Humeral Shaft Fractures. JAMA. 2024 Apr 2;331(13):1149-1151. doi: 10.1001/jama.2024.2671.
citation: Ibounig T, Juurakko J, Lahdeoja T, Sumrein BO, Jarvinen TLN, Paavola M, Ardern CL, Karjalainen T, Taimela S, Ramo L. Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data. BMC Med Res Methodol. 2022 Nov 10;22(1):291. doi: 10.1186/s12874-022-01776-6.