Operative and Nonoperative Treatment of Humeral Shaft Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by McGill University Health Center
Sponsor:
Collaborator:
Canadian Orthopaedic Trauma Society
Information provided by (Responsible Party):
greg.berry, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00878319
First received: April 7, 2009
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

The purpose of this research study is to compare two different ways of treating a broken arm (fractured humerus) using either, the nonoperative approach or the operative, open reduction and internal fixation (ORIF). The study will examine which treatment will overall give better results in regards to shoulder and elbow function, residual pain and deformity.

Patients who agree to consent to participation in this study will be randomly selected to receive one of the two treatment methods:

  1. Nonoperative: This method requires the application of a plaster sugartong splint for 10 - 14 days followed by a transition to a functional (coaptation) brace to be worn for 4-6 weeks. Patients will be followed by physiotherapy from the baseline visit at 2 weeks.
  2. Operative: This treatment option involves an operative procedure for fixation of the broken bone with plates and screws (open reduction internal fixation - ORIF). With this method of treatment, a splint or sling is worn for comfort postoperatively. The patient will be followed by physiotherapy after the post-operative visit at 2 weeks.

Standard follow-up clinic visits at 2 weeks, 6 weeks, 4 months, 6 months and 12 months will be arranged from the date of randomization. The patient will be asked to complete two questionnaires, reporting the level of wellbeing and physical function. These questionnaires will be given to the patient at the time of baseline visit at 2 weeks and again at 6 weeks, 4 months, 6 months and 12 months. They should take approximately 10 - 20 minutes to complete. At each appointment, the patients will be x-rayed until healing has occurred, examined and evaluated (Constant Shoulder Score) by the surgeon and followed by physiotherapy for gentle range of motion (ROM) exercises progressing to strengthening and proprioception of the elbow and shoulder.


Condition Intervention Phase
Humeral Mid-shaft Fractures
Procedure: Open reduction and internal fixation (ORIF)
Other: Non-surgical
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Trial Comparing Operative and Nonoperative Treatment of Humeral Shaft Fractures

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Validated functional outcome tools to be used: disability shoulder, arm, hand (DASH), short musculoskeletal functional assessment (SMFA) and Constant Shoulder Score. [ Time Frame: 2 and 6 weeks, 4, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of Motion will be measured with a goniometer for both the shoulder/elbow with comparative values taken for a contralateral shoulder/elbow. [ Time Frame: 2 and 6 weeks; 4, 6 and 12 months ] [ Designated as safety issue: No ]
  • Radiologic Outcome: Antero-posterior and lateral radiographs [ Time Frame: 2 and 6 weeks; 4, 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2009
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgical
Surgical intervention: open reduction and internal fixation (ORIF)
Procedure: Open reduction and internal fixation (ORIF)
Antero-latero or posterior surgical approach using a 3.5 mm or 4.5 mm dynamic compression plate (DCP) or 4.5 mm broad DCP.
Other Name: In cases of osteopenia, a plate with locking screws can be used.
Active Comparator: Non-surgical
Sugartong splint followed by transition to functional co-aptation brace
Other: Non-surgical
Sugartong splint followed by transition to functional co-aptation brace

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Over 18 y/o with skeletal maturity, and consenting to participate
  2. A displaced fracture of the humeral diaphysis amenable to fixation with a plate with no other injuries to the same limb
  3. 21 days or less between injury and surgery
  4. Medically fit for anaesthesia
  5. The mental faculties to participate in post-op evaluation
  6. Fracture amenable to both treatment methods

Exclusion Criteria:

  1. Open fracture
  2. Neurovascular injury requiring repair in the same limb (excluding radial nerve palsy)
  3. Active infection in the area of the surgical approach
  4. Prior injury, degenerative condition, or congenital condition to the shoulder, arm or elbow
  5. Bone disorder which may impair bone healing
  6. Polytrauma with other limb fractures
  7. Incapable of ensuring follow-up
  8. Pathologic fracture
  9. Already enrolled in another research clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878319

Contacts
Contact: Fiona Houghton 514-934-1934 ext 42736 fiona.houghton@muhc.mcgill.ca
Contact: Gregory K. Berry, MDCM FRCSC 514-934-1934 ext 42735 gregberry1@mac.com

Locations
Canada, Quebec
McGill University Health Centre - Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Fiona Houghton    514-934-1934 ext 42736    fiona.houghton@muhc.mcgill.ca   
Contact: Gregory K. Berry, MCDM FRCSC    514-934-1934 ext 42735    gregberry1@mac.com   
Principal Investigator: Gregory K. Berry, MDCM FRCSC         
Sponsors and Collaborators
McGill University Health Center
Canadian Orthopaedic Trauma Society
Investigators
Principal Investigator: Gregory K. Berry, MDCM FRCSC McGill University Health Center
  More Information

No publications provided

Responsible Party: greg.berry, MDCM FRCSC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00878319     History of Changes
Other Study ID Numbers: SDR-08-055
Study First Received: April 7, 2009
Last Updated: October 15, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Humeral
diaphyseal (mid-shaft)
fracture
operative
non-operative

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 19, 2014