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

NCT01719887 | Active Not Recruiting

• 1 other identifier: HUS-118/13/03/02/2012
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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. 1.Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate.
2. 2.Conservative treatment with functional bracing

Conditions

Fracture

Keywords

humerus; humeral; shaft; diaphysis; fracture; RCT

Outcome Measures

Primary Outcomes (1)

• The Disabilities of the Arm, Shoulder and Hand Score (DASH)

  at 12 months

Secondary Outcomes (11)

• Subjective assessment of the function of the upper extremity

  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

  6 wks, 3, 6, 12 mo, 2, 5, 10 years

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

Conservative treatment with functional brace and physiotherapy.

Device: Conservative treatment; Other: Physiotherapy

Operative treatment

EXPERIMENTAL

Operative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.

Procedure: Operative treatment; Other: Physiotherapy

Interventions

Conservative treatment DEVICE

Conservative treatment with functional brace.

Conservative treatment

Operative treatment PROCEDURE

Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.

Operative treatment

Physiotherapy OTHER

Physiotherapy is arranged to both groups at 3 and 9 wks.

Conservative treatment; Operative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Töölö Hospital: lead
• Helsinki University Central Hospital: collaborator
• Tampere University Hospital: collaborator
• Finnish Institute for Health and Welfare: collaborator

Study Sites (2)

Töölö Hospital, Helsinki University Central Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Related Publications (5)

• 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.

  PMID: 28694341 BACKGROUND

• 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.

  PMID: 32396179 RESULT

• 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.

  PMID: 33851991 RESULT

• 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.

  PMID: 38436996 RESULT

• 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.

  PMID: 36357855 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Conservative Treatment; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mika Paavola, MD, PhD

  Töölö Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: November 1, 2012
• Study Start: November 4, 2012
• Primary Completion: January 1, 2019
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

FI (2)