Clinical Trial

Treatment of Humeral Shaft Fractures

Study Description

Operative and Nonoperative Treatment of Humeral Shaft Fractures

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Procedure - Open reduction and internal fixation (ORIF)

Antero-latero or posterior surgical approach using dynamic compression plate

Non-surgical

Sugartong splint followed by transition to functional co-aptation brace

Additional Information

Official Study Title

A Randomized Prospective Trial Comparing Operative and Nonoperative Treatment of Humeral Shaft Fractures

Clinical Trial ID

NCT00878319

ParticipAid ID

lej25e