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HUmeral Shaft Fracture FIXation Study (HU-FIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689335
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
NHS Lothian
University of Edinburgh
Information provided by (Responsible Party):
William Oliver, Royal Infirmary of Edinburgh

Brief Summary:

Fractures of the humeral shaft (upper arm bone) account for approximately 1% of all adult fractures in the United Kingdom. Historically, these injuries have been treated using a cast and/or brace, with immediate surgical fixation reserved for severely- or multiply-injured patients. However, treatment with a brace is associated with several important problems, including poor alignment of the healed bones and shoulder/elbow stiffness. The brace is usually worn for up to 3 months, which interferes with patients' everyday activities and sleeping, and can predispose to skin problems. For 10-15% of patients treated with a brace, their fracture will not heal and will require surgery several months after the original injury, which is more difficult and carries a higher risk of complications. Recent studies suggest that undertaking immediate surgical fixation more often could improve healing and functional outcome for patients with humeral shaft fractures. The only published randomised controlled trial (RCT) to date showed no difference in clinical outcome between conservative and operative management; unfortunately, however, the operative technique used was unusual and would be considered highly suboptimal in most Western countries.

This study will include adult patients (≥16 years), with capacity to consent and complete post-operative questionnaires in English, presenting to a single Orthopaedic trauma unit. Participants will be randomised to either non-operative treatment (with a brace) or operative treatment (i.e. surgical fixation). The investigators will assess whether there is a difference between the groups in terms of patient-reported outcome scores, fracture healing, complications, pain and return to work/sport over a one-year follow-up period. Participants will be enrolled into the study after obtaining informed consent. Following randomisation (to either non-operative treatment or surgical fixation), participants will then be reviewed at several defined timepoints, with a combination of clinical examination, X-rays and patient-reported outcome scores. The investigators hope that study results will enable surgeons to make better-informed decisions when managing patients with humeral shaft fractures.


Condition or disease Intervention/treatment Phase
Closed Fracture of Shaft of Humerus Procedure: Operative Device: Humeral brace Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial, with 1:1 allocation into one of 2 treatment arms (operative or non-operative treatment). The randomisation is stratified by patient age (<65 years old or ≥65 years old) to ensure approximately equal numbers by age in each treatment arm.
Masking: None (Open Label)
Masking Description: There is no blinding possible in this study, as the presence or absence of a skin incision/surgical scar is obvious to both patient and clinician during follow-up assessment.
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial of Operative Versus Nonoperative Management of Fractures of the Humeral Diaphysis
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Operative
Surgical fixation of the humeral shaft fracture
Procedure: Operative
Open reduction and internal fixation, using a plate and screws (the exact surgical approach and fixation technique utilised will be at the discretion of the treating surgeon)

Active Comparator: Non-operative
Conservative treatment of the humeral shaft fracture, using a humeral brace
Device: Humeral brace
Immobilisation in a U-slab or hanging cast, followed by application of a lightweight prefabricated humeral brace




Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 3 months ]
    The DASH score is a functional rating scale developed in 1996, which has been used extensively as a research tool in upper limb surgery. It consists of a 30-item self-reported questionnaire, and 2 optional modules assessing work and sports/performing arts. Patient symptoms (including pain, weakness, stiffness and tingling/numbness) and functional status (including physical, social and psychological aspects) during the week prior to survey completion are assessed. A final score is awarded from 0 to 100, with 0 representing no disability and 100 the worst possible disability. The DASH score at 3 months post-intervention will form the primary outcome measure.


Secondary Outcome Measures :
  1. Change in Disabilities of the Arm, Shoulder and Hand (DASH) score [ Time Frame: 6 weeks, 3 months, 6 months, one year ]
    The DASH score is a functional rating scale developed in 1996, which has been used extensively as a research tool in upper limb surgery. It consists of a 30-item self-reported questionnaire, and 2 optional modules assessing work and sports/performing arts. Patient symptoms (including pain, weakness, stiffness and tingling/numbness) and functional status (including physical, social and psychological aspects) during the week prior to survey completion are assessed. A final score is awarded from 0 to 100, with 0 representing no disability and 100 the worst possible disability. Change in the DASH score over the one-year follow-up period will form a secondary outcome measure.

  2. Pain visual analogue scale (VAS) [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, one year ]
    Assessment of pain in the injured arm, from 0 (no pain) to 10 (worst pain imaginable).

  3. Treatment complications [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, one year ]
    Complications of treatment, including neurovascular injury, superficial/deep infection, failure of fixation, revision surgery, skin complications (including eczema and cellulitis) and complex regional pain syndrome (CRPS).

  4. Return to work/sport [ Time Frame: 6 weeks, 3 months, 6 months, one year ]
    Time taken to return to work and sport (if relevant).

  5. Satisfaction with service visual analogue scale (VAS) [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, one year ]
    Assessment of overall satisfaction with clinical care provided, from 0 (completely dissatisfied) to 100 (completely satisfied).

  6. Shoulder/elbow range of motion (measured in degrees) [ Time Frame: 6 weeks, 3 months, 6 months, one year ]
    Recovery of shoulder and elbow range of motion over the one-year follow-up period. This will be assessed through clinical measurement of shoulder elevation, abduction, external and internal rotation, and elbow flexion and extension.

  7. Radiographic assessment [ Time Frame: 6 weeks, 3 months, one year ]
    Standard anteroposterior and lateral X-rays of the humerus over the one-year follow-up period. These X-rays will be used to assess progression of fracture healing, as well as the final humeral deformity (measured in degrees) in the coronal (varus/valgus) and sagittal (procurvatum/recurvatum) planes once healing has occurred.

  8. EuroQol (EQ-5D) Health Outcome score [ Time Frame: 6 weeks, 3 months, 6 months, one year ]
    A standardised instrument for use as a measure of health outcome.

  9. 12-item Short Form (SF-12) Health Survey score [ Time Frame: 6 weeks, 3 months, 6 months, one year ]
    A standardised instrument for use as a measure of health outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Fracture of the humeral shaft
  2. Closed injury
  3. Age ≥16 years
  4. Able to provide informed consent in English
  5. Surgery performed within 3 weeks of date of injury

Exclusion Criteria:

  1. Completely undisplaced fractures
  2. Injuries considered to be an absolute indication for surgery (including severe associated neurovascular injury, open fractures and bilateral injuries)
  3. Patients with a periprosthetic or pathological fracture
  4. Patients with an additional spine or limb injury (including those with polytrauma), which may impact upon functional rehabilitation
  5. Patients medically unfit for surgery
  6. Very frail patients (CSHA Clinical Frailty Score ≥6/9)
  7. Pregnant women with predetermined treatment
  8. Patients declining operative management
  9. Patients unable to provide informed consent in English
  10. Patients unable to comply with post-operative data gathering, including completing questionnaires in English
  11. Non-residents, unable to return to the Unit for follow-up for a period of 1-year
  12. Where the treating surgeon does not feel that inclusion in the trial is in the patient's best interests, either due to fracture pattern or patient factors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689335


Contacts
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Contact: William M Oliver, MBBS (Hons), MRCSEd +44 131 242 3459 william.m.oliver@doctors.org.uk

Locations
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United Kingdom
Edinburgh Orthopaedic Trauma Unit, Royal Infirmary of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH5 3DB
Contact: William M Oliver, MBBS (Hons), MRCSEd    +44 131 242 3459    william.m.oliver@doctors.org.uk   
Principal Investigator: Samuel G Molyneux, FRCSEd (Tr&Orth)         
Sub-Investigator: William M Oliver, MBBS (Hons), MRCSEd         
Sub-Investigator: Andrew D Duckworth, FRCSEd (Tr&Orth), PhD         
Sub-Investigator: Nicholas D Clement, FRCSEd (Tr&Orth), PhD         
Sub-Investigator: Timothy O White, MD, FRCSEd (Tr&Orth)         
Sponsors and Collaborators
Royal Infirmary of Edinburgh
NHS Lothian
University of Edinburgh
Investigators
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Principal Investigator: Samuel G Molyneux, FRCSEd (Tr&Orth) Royal Infirmary of Edinburgh
Publications:
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Responsible Party: William Oliver, Co-Investigator, Clinical Research Fellow, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier: NCT03689335    
Other Study ID Numbers: 2018/0223
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries