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FractureNCT01719887

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

A study testing Conservative treatment, Operative treatment and Physiotherapy in people with Fracture, run by Töölö Hospital at 2 sites in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fracture
What is being tested?
Conservative treatment, Operative treatment and Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
2 sitesFinland
Study dates
4 Nov 2012to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • Töölö Hospital, Helsinki University Central Hospital

    Helsinki

  • Tampere University Hospital

    Tampere

Other trials in Finland

About this study

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

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:

Read more
  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.

Conditions
Fracture
Being tested
Conservative treatment, Operative treatment, Physiotherapy
Keywords
humerus, humeral, shaft, diaphysis, fracture, RCT
Medical subject headings
Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conservative treatmentDevice

    Conservative treatment with functional brace.

  • Operative treatmentProcedure or surgery

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

  • PhysiotherapyOther

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

Study groups in NCT01719887
Study groupRoleWhat they receive
Conservative treatmentActive comparatorConservative treatment with functional brace and physiotherapy.
Receives: Device: Conservative treatment; Other: Physiotherapy
Operative treatmentExperimentalOperative treatment with open reduction and internal fixation with 4,5mm locking compression plate. Physiotherapy at 3 and 9 wks.
Receives: Procedure: Operative treatment; Other: Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at 12 months

Secondary outcomes (11)

  1. Subjective assessment of the function of the upper extremity

    Numerical Rating Scale (NRS) 0-10

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

  2. Constant Score

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

  3. Elbow ROM

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

  4. Health-related quality of life (15D)

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

  5. Complications

    Incidence of complications (i.e. non-union, malunion, re-fracture, reoperation, infection and iatrogenic radial palsy) is recorded and compared between study groups.

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

  6. Cost-effectiveness

    Quality-adjusted life years/months measured as a change in 15D tool, pain-NRS and other outcome measures.

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

  7. Subjective assessment of the function of the upper extremity

    Likert Scale 1-7

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

  8. Subjective assessment of the function of the elbow

    Numerical Rating Scale (NRS) 0-10

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

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

    Measured: at 6 wks, 3, 6 mo, 2, 5, 10 years

  10. Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10

    Measured: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years

  11. Percentage of patients with acceptable symptom state (PASS)

    Measured: at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study start4 Nov 2012
  3. Primary completionJan 2019
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719887
Sponsor's protocol ID
HUS-118/13/03/02/2012
Status last verified
Sep 2026
First submitted
28 Oct 2012
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28694341

  • 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.

    PubMed 32396179

  • 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.

    PubMed 33851991

  • 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.

    PubMed 38436996

  • 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.

    PubMed 36357855

Questions about this trial

What is this clinical trial studying?

A study testing Conservative treatment, Operative treatment and Physiotherapy in people with Fracture, run by Töölö Hospital at 2 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Disabilities of the Arm, Shoulder and Hand Score (DASH) (time frame: at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01719887, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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