HUmeral Shaft Fracture FIXation Study

NCT03689335 | Completed FDA Device

• 1 other identifier: 2018/0223
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Closed Fracture of Shaft of Humerus

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months

Secondary Outcomes (9)

• Change in Disabilities of the Arm, Shoulder and Hand (DASH) score

  6 weeks, 3 months, 6 months, one year

• Pain visual analogue scale (VAS)

  2 weeks, 6 weeks, 3 months, 6 months, one year

• Treatment complications

  2 weeks, 6 weeks, 3 months, 6 months, one year

• Return to work/sport

  6 weeks, 3 months, 6 months, one year

• Satisfaction with service visual analogue scale (VAS)

  2 weeks, 6 weeks, 3 months, 6 months, one year

Study Arms (2)

Operative

ACTIVE COMPARATOR

Surgical fixation of the humeral shaft fracture

Procedure: Operative

Non-operative

ACTIVE COMPARATOR

Conservative treatment of the humeral shaft fracture, using a humeral brace

Device: Humeral brace

Interventions

Operative PROCEDURE

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)

Operative

Humeral brace DEVICE

Immobilisation in a U-slab or hanging cast, followed by application of a lightweight prefabricated humeral brace

Non-operative

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Completely undisplaced fractures
• Injuries considered to be an absolute indication for surgery (including severe associated neurovascular injury, open fractures and bilateral injuries)
• Patients with a periprosthetic or pathological fracture
• Patients with an additional spine or limb injury (including those with polytrauma), which may impact upon functional rehabilitation
• Patients medically unfit for surgery
• Very frail patients (CSHA Clinical Frailty Score ≥6/9)
• Pregnant women with predetermined treatment
• Patients declining operative management
• Patients unable to provide informed consent in English
• Patients unable to comply with post-operative data gathering, including completing questionnaires in English
• Non-residents, unable to return to the Unit for follow-up for a period of 1-year

Sponsors & Collaborators

• Royal Infirmary of Edinburgh: lead
• NHS Lothian: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Edinburgh Orthopaedic Trauma Unit, Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH5 3DB, United Kingdom

Location

Related Publications (2)

• Oliver WM, Carter TH, Graham C, White TO, Clement ND, Duckworth AD, Molyneux SG. A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol. Trials. 2019 Aug 5;20(1):475. doi: 10.1186/s13063-019-3576-0.

  PMID: 31383027 BACKGROUND

• Oliver WM, Bell KR, Carter TH, Graham C, White TO, Clement ND, Duckworth AD, Molyneux SG. Operative vs Nonoperative Management of Fractures of the Humeral Diaphysis: The Humeral Shaft Fracture Fixation Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):508-516. doi: 10.1001/jamasurg.2025.0301.

  PMID: 40136271 DERIVED

Study Officials

• Samuel G Molyneux, FRCSEd (Tr&Orth)

  Royal Infirmary of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator, Clinical Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 28, 2018
• Study Start: September 17, 2018
• Primary Completion: October 26, 2022
• Study Completion: October 2, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

GB (1)