Humeral Diaphyseal Fracture Clinical Trial
Official title:
A Randomized Prospective Trial Comparing 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.
Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all
fractures. Overall the incidence is higher in women and typically presents at a more advanced
age in this population, rendering fixation more difficult due to osteoporosis. The majority
of fractures of the humeral diaphysis occur in the mid-shaft and proximal third and the
majority are simple (or non-comminuted) in pattern.
Presently, the standard treatment of isolated humeral diaphysis fractures is nonoperative
care using splints, braces, casts and slings. Most centres in North America and Europe favor
functional bracing with a coaptation splint given the positive results reported with this
device, despite the prolonged period of pain and discomfort as well as the need for repeated
clinic follow-up visits associated with it.
Presently there are no published prospective comparative studies that systematically evaluate
patient function following the operative or nonoperative treatment of humeral shaft
fractures.
Clinical evaluations following functional bracing using patient-based outcome tools revealed
a 20% nonunion rate in patients suffering a simple (non-comminuted) fracture. Invariably,
this led to surgical intervention to achieve union. In those whose fracture healed with the
splint, only 50% reported a full recovery while none of those requiring surgery for nonunion
did so. This low rate of functional recovery may be due in part to the high rate of shoulder
stiffness following functional bracing. Significant stiffness in the shoulder following
functional bracing has ranged from 14-60% with an average of 40%.
The advantages of open reduction and plate fixation of humeral shaft fractures include a
direct approach to the fracture site with direct visualization and protection of the radial
nerve (depending on fracture level and approach), the possibility of rigid compressive
fixation, and the opportunity for bone grafting and/or radial nerve exploration if needed.
Importantly, it permits rapid mobilization of the shoulder and elbow, obviating the need of
immobilization, and ensures anatomic or near anatomic alignment. These advantages must be
weighed against the small risk of infection (<1-6%) with most occurring after open fractures
or severe crush injury, nonunion (4-6%) especially in high energy injuries, and iatrogenic
radial nerve injury (1-3%) the vast majority of which are transient.
Operative care: Fixation with regular or broad 3.5mm or 4.5mm dynamic compression plate (DCP)
using standard technique will be applied in cases with normal bone density; in the face of
osteopenic bone, locked-plate implants will be employed at the discretion of the surgeon.
Bone graft will not be used routinely as these are simple fracture patterns. Postoperative
splinting (or sling) will be maintained for 10 - 14 days followed by gentle ROM exercises
under physiotherapy supervision. Strengthening and proprioception will be begun once fracture
healing has occurred, typically at 6-8 weeks.
Conservative care will entail the application of a plaster sugartong splint for 10-14 days
followed by transition to a functional (coaptation) brace, to be applied by a qualified
orthotist. Gentle ROM exercises of the elbow and shoulder will begin as tolerated under the
supervision of a physiotherapist after 2 weeks with strengthening and proprioception added
once fracture healing has occurred, typically at 6-8 weeks.
This multicentre prospective randomized trial will involve the Canadian Orthopaedic Trauma
Society (COTS), an association of trauma surgeons involved in collaborative outcomes research
with a proven track record of research and publication. Patients with a humeral diaphyseal
fracture who meet all eligibility criteria and provide consent to participate will be
randomly assigned to the operative or splint/brace treatment group. Patients will start
physiotherapy at 2 weeks post-randomization (splint/brace group)or 2 weeks post-surgery for
gentle ROM exercises. The operative group will progress to strengthening and proprioception
at 4-6 weeks. The splint/brace group will only progress at the 6-8 weeks mark once union has
occurred. Evaluation at 2 and 6 weeks, 4, 6, and 12 months will include functional, clinical
and radiological parameters. Functional evaluation will include the DASH, SMFA questionnaires
and the Constant Shoulder Score. Clinical outcome will evaluate range and motion including
the shoulder and elbow of both the affected arm and contralateral shoulder and elbow.
Standard radiographic parameters will be measured. The primary outcome measure will be
functional outcome as measured with the DASH. Appropriate statistical analyses will be
performed on the data. Sample size calculation reveals the need for 90 patients per treatment
arm. A census of the centers committed to the study predicts a 1-24 month recruitment period.
Patient follow-up will end at the 12 month visit.
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