Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 33 for:    humeral shaft

Operative and Nonoperative Treatment of Humeral Shaft Fractures

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00878319
Recruitment Status : Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Canadian Orthopaedic Trauma Society
Information provided by (Responsible Party):
Greg K. Berry, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

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 or disease Intervention/treatment Phase
Humeral Diaphyseal Fracture Procedure: Open reduction and internal fixation (ORIF) Other: Non-surgical Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Trial Comparing Operative and Nonoperative Treatment of Humeral Shaft Fractures
Actual Study Start Date : August 19, 2009
Actual Primary Completion Date : February 4, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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 dynamic compression plate
Other Name: 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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Radiologic Outcome: Antero-posterior and lateral radiographs [ Time Frame: 2 and 6 weeks; 4, 6 and 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00878319


Locations
Layout table for location information
Canada, Quebec
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Canadian Orthopaedic Trauma Society
Investigators
Layout table for investigator information
Principal Investigator: Gregory K. Berry, MDCM FRCSC McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications:
Rockwood CA, Jr, Green DP. Fractures in Adults. Fourth Edition. Philadelphia. Lippincott-Raven, p 1025-53, 1996

Layout table for additonal information
Responsible Party: Greg K. Berry, MD, MDCM FRCSC, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT00878319    
Other Study ID Numbers: SDR-08-055
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Greg K. Berry, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Humeral
diaphyseal (mid-shaft)
fracture
operative
non-operative
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries