Operative and Nonoperative Treatment of Humeral Shaft Fractures
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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.
- 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 |
- 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 ]
- 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 2012 |
| Estimated Primary Completion Date: | May 2012 (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 |
Inclusion Criteria:
- Over 18 y/o with skeletal maturity, and consenting to participate
- A displaced fracture of the humeral diaphysis amenable to fixation with a plate with no other injuries to the same limb
- 21 days or less between injury and surgery
- Medically fit for anaesthesia
- The mental faculties to participate in post-op evaluation
- Fracture amenable to both treatment methods
Exclusion Criteria:
- Open fracture
- Neurovascular injury requiring repair in the same limb (excluding radial nerve palsy)
- Active infection in the area of the surgical approach
- Prior injury, degenerative condition, or congenital condition to the shoulder, arm or elbow
- Bone disorder which may impair bone healing
- Polytrauma with other limb fractures
- Incapable of ensuring follow-up
- Pathologic fracture
- Already enrolled in another research clinical trial
Contacts and Locations| Canada, Quebec | |
| McGill University Health Centre - Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Principal Investigator: | Gregory K. Berry, MDCM FRCSC | McGill University Health Center |
More Information
No publications provided
| Responsible Party: | Gregory K. Berry MDCM FRCSC, McGill University Health Centre |
| ClinicalTrials.gov Identifier: | NCT00878319 History of Changes |
| Other Study ID Numbers: | SDR-08-055 |
| Study First Received: | April 7, 2009 |
| Last Updated: | August 5, 2009 |
| 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 June 17, 2013