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Fracture of Shaft of HumerusPhase 3NCT02418260

Surgical Interventions for the Treatment of Humeral Shaft Fractures

A Phase 3 study testing Bridge Plate osteosynthesis, Locked intramedullary nail osteosynthesis and Open reduction and plate osteosynthesis in people with Fracture of Shaft of Humerus and Humerus Fracture, run by Federal University of São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study intends to determine the best surgical treatment for humeral shaft fractures. One third of the patients will be treated with open reduction and internal fixation with plate; one third, with bridge plate technique and the remaining third with locked intramedullary nail. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Bridge Plate osteosynthesis, Locked intramedullary nail osteosynthesis and Open reduction and plate osteosynthesis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBrazil
Study dates
Jun 2014to Jun 2019
Phase
Phase 3
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Complete fracture with angulation greater than 20 degrees, rotation greater than 30 degrees and/or shortening greater than 3 cm.
  • Fractures located from 4 cm distal to the surgical neck to 2 cm proximal to the end of the medullary canal.

Who cannot join

  • fractures older than 3 weeks
  • pathologic fractures
  • fractures with extension to elbow or shoulder joint
  • patients with ipsilateral upper extremity fracture or injury
  • fractures with associated neurologic injury
  • patients with previous pathology of the shoulder, arm or elbow that cause pain or range of motion limitation
  • patients who do not agree with the terms of the study

Trial locations and contacts

1 site in 1 country.

Rafael Pierami, M.D. contact

+5511982325308

rafael_pierami@hotmail.com

Marcel JS Tamaoki, Ph.D. contact

+5511941713337

marceltamaoki@terra.com.br

Brazil1 site, 1 recruiting

  • Hand and Upper Limb Surgery Discipline

    São Paulo, 04038001

    Rafael Pierami, M.D., +5511982325308, rafael_pierami@hotmail.com

    Marcel JS Tamaoki, Ph.D., +5511941713337, marceltamaoki@terra.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: Surgical Interventions for the Treatment of Humeral Shaft Fractures: Randomized Controlled Clinical Trial

This study intends to determine the best surgical treatment for humeral shaft fractures. One third of the patients will be treated with open reduction and internal fixation with plate; one third, with bridge plate technique and the remaining third with locked intramedullary nail.

Read the detailed description

Humerus diaphyseal fractures are amongst the most common of the appendicular skeleton. Despite the fact that the conservative treatment is still the gold standard for the majority of these fractures, this method was not proven to be superior when compared to the surgical treatment. Surgical options for the treatment of humeral shaft fractures range from open reduction and internal fixation with plate to minimally invasive methods (bridge plate and intramedullary nail) and the best method has yet to be determined. The goal of this study is to determine the best surgical option for the treatment of humeral shaft fractures. For this, will be recruited 105 patients with humeral shaft fractures, wich will be allocated, randomly, in 3 distinct groups. Each patient will be submitted to one of three possible methods of humerus osteosynthesis: open reduction and internal fixation with plate (ORIF), closed reduction and fixation with bridge plate or closed reduction and fixation with intramedullary nail. All data will be paired according to the age, gender, fracture classification, patient comorbidities and smoking habit. The Pearson's chi-square" test will be used to analyze the results of the three groups regarding categorical variables, and Student t-test (parametric) will be used to compare groups with respect to the numerical variables. The investigators expect to conclude that the methods of minimally invasive osteosynthesis of humeral shaft fractures have similar or better functional and radiographic outcomes, compared to the method of open reduction and internal fixation with a plate, with lesser risk of complications and an earlier return to activities.

Being tested
Bridge Plate osteosynthesis, Locked intramedullary nail osteosynthesis, Open reduction and plate osteosynthesis
Keywords
Humerus, shaft, diaphyseal, fractures
Medical subject headings
Humeral Fractures, Fractures, Bone

What participants receive

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

  • Bridge Plate osteosynthesisProcedure or surgery

    Also called Bridge Plate

    Trough two anterior skin incisions, the 4.5mm narrow DCP plate will be placed on the anterior surface of the humerus and, after indirect reduction, it will be fixed to the bone with 2 proximal and 2 distal screws.

  • Locked intramedullary nail osteosynthesisProcedure or surgery

    Also called IMN

    Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.

  • Open reduction and plate osteosynthesisProcedure or surgery

    Also called ORIF

    Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.

Study groups in NCT02418260
Study groupRoleWhat they receive
Open reduction and plate osteosynthesisActive comparatorOpen reduction and internal fixation with DCP 4.5mm plate.
Receives: Procedure: Open reduction and plate osteosynthesis
Bridge PlateExperimentalPatients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used)
Receives: Procedure: Bridge Plate osteosynthesis
Intramedullary nailExperimentalPatients will be submitted to closed reduction and locked intramedullary nail osteosynthesis.
Receives: Procedure: Locked intramedullary nail osteosynthesis

What is being measured

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

  1. Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)

    The survey will be applied at 8, 24 and 48 weeks after the intervention

    Measured: 48 weeks

Secondary outcomes (6)

  1. Changes in the Visual Analog Scale for Pain (VAS)

    The VAS survey will be applied 1, 8, 24 and 48 weeks after the intervention

    Measured: 48 weeks

  2. Changes in the Constant-Murley Shoulder Outcome Score

    The Score will be obtained at 8, 24 and 48 weeks after the intervention

    Measured: 48 weeks

  3. Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)

    Complications are defined as nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow.

    Measured: 48 weeks

  4. Radiographic angular deformity

    Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure.

    Measured: at 48 weeks

  5. Time to previous activities return

    time to return to previous acitivities will bem described in weeks after the surgery

    Measured: 48 weeks

  6. Failure (need for aditional surgical procedure)

    Failure is described as need for aditional surgical procedure.

    Measured: 48 weeks

Timeline

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

  1. First posted16 Apr 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02418260
Sponsor's protocol ID
24997313.8.0000.5505
Status last verified
Oct 2017
First submitted
8 Apr 2015
Last updated
6 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • MANN RJ, NEAL EG. FRACTURES OF THE SHAFT OF THE HUMERUS IN ADULTS. South Med J. 1965 Mar;58:264-8. doi: 10.1097/00007611-196503000-00002. No abstract available.

    PubMed 14261543

  • Rose SH, Melton LJ 3rd, Morrey BF, Ilstrup DM, Riggs BL. Epidemiologic features of humeral fractures. Clin Orthop Relat Res. 1982 Aug;(168):24-30.

    PubMed 7105548

  • McKee MD LS. Humeral Shaft Fractures. Rockwood and Green's Fractures in Adults. 7th ed. Philadelphia: Lippincot Williams & Wilkins; 2009

  • Baumgaertel F, Buhl M, Rahn BA. Fracture healing in biological plate osteosynthesis. Injury. 1998;29 Suppl 3:C3-6. doi: 10.1016/s0020-1383(98)95002-1.

    PubMed 10341891

  • Bhandari M, Guyatt GH, Swiontkowski MF. User's guide to the orthopaedic literature: how to use an article about a surgical therapy. J Bone Joint Surg Am. 2001 Jun;83(6):916-26. doi: 10.2106/00004623-200106000-00015. No abstract available.

    PubMed 11407801

  • Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.

    PubMed 21350618

  • Solway S, Beaton, D.E., McConnell, S., & Bombardier, C. The DASH Outcome measure user's manual (2nd Edition). Institute for Work & Health. Toronto2002.

  • Orfale AG, Araujo PM, Ferraz MB, Natour J. Translation into Brazilian Portuguese, cultural adaptation and evaluation of the reliability of the Disabilities of the Arm, Shoulder and Hand Questionnaire. Braz J Med Biol Res. 2005 Feb;38(2):293-302. doi: 10.1590/s0100-879x2005000200018. Epub 2005 Feb 15.

    PubMed 15785841

  • Flandry F, Hunt JP, Terry GC, Hughston JC. Analysis of subjective knee complaints using visual analog scales. Am J Sports Med. 1991 Mar-Apr;19(2):112-8. doi: 10.1177/036354659101900204.

    PubMed 2039061

  • Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

    PubMed 3791738

  • Balfour GW, Marrero CE. Fracture brace for the treatment of humerus shaft fractures caused by gunshot wounds. Orthop Clin North Am. 1995 Jan;26(1):55-63.

    PubMed 7838503

  • Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977 Jul;59(5):596-601.

    PubMed 873955

  • Ward EF SF, Hughes JL. Fractures of the diaphyseal humerus. In: Saunders, ed. Skeletal trauma: fractures, dislocation, ligamentous injuries. Philadelphia: Saunders; 1998:1523-47

  • Balfour GW, Mooney V, Ashby ME. Diaphyseal fractures of the humerus treated with a ready-made fracture brace. J Bone Joint Surg Am. 1982 Jan;64(1):11-3. No abstract available.

    PubMed 7054192

  • Amillo S, Barrios RH, Martinez-Peric R, Losada JI. Surgical treatment of the radial nerve lesions associated with fractures of the humerus. J Orthop Trauma. 1993;7(3):211-5. doi: 10.1097/00005131-199306000-00002.

    PubMed 8326423

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bridge Plate osteosynthesis, Locked intramedullary nail osteosynthesis and Open reduction and plate osteosynthesis in people with Fracture of Shaft of Humerus and Humerus Fracture, run by Federal University of São Paulo at 1 site in Brazil.

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Rafael Pierami, M.D. (+5511982325308, rafael_pierami@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: 48 weeks). 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 NCT02418260, which also lists 43 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 6 Oct 2017.

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