Closed Fracture of Shaft of Humerus Clinical Trial
Official title:
Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study
The subject's broken humerus (arm) is suitable for treatment with a fracture brace or
operative fixation with plate and screws. Both of these types of treatments are often used by
doctors to fix broken bones. If the subject agrees to participate in this study, the subject
will be assigned by the treating surgeon to one of the following groups:
Group B: Non-operative treatment with a fracture brace Group P: a plate & screws - a metal
device placed on top of the bone.
The investigators will collect information about the subject's arm fracture as it is treated
with examinations and X-rays. X-rays will be obtained often in the first several months,
depending on how the fracture is healing. This is determined by the doctor and will not be
determined by the subject's participation in this research study.
Both treatments are routinely used and this study hopes to provide information regarding each
type of treatment on the subject's functional outcome. A subject's treatment will not be
affected whether they choose to participate in this research study or not.
The treatment of these subjects is no different because of this study. The treating surgeon
will discuss with the patient their preferred treatment for the isolated humeral shaft
fracture. If they meet the inclusion/exclusion criteria, they will be approached for
participation in one of two treatment groups depending on a previous decision by the patient
and the treating surgeon.
Hypotheses:
1. Patients with an isolated humeral shaft fracture that are plated will have a more rapid
return to ADL's, work and full functional capacity than patients treated conservatively.
2. Patients treated with plate technique will have a more rapid improvement in functional
outcome scores, decreased pain scores and patient satisfaction than those managed
conservatively.
3. Complication rates of infection and iatrogenic neurologic injury will be higher in
patients treated operatively.
4. Nonunion and malunion will be higher in patients managed conservatively.
A. Rationale Humeral shaft fractures (OTA 12A, B or C) are not uncommon injuries and have
been long considered fractures, which respond well to conservative (or nonoperative)
management. Since Bohler's (1964) statement that humeral shaft fractures are "the most benign
of all fractures of the long bones", many additional peer-reviewed publications have
concluded that conservative management of this injury, in isolation, produces an excellent
and uncomplicated result. Sarmiento's work resulted in a treatment algorithm utilizing
functional bracing which remains the accepted standard of care for isolated humeral shaft
fractures. Much of the early work on operative treatment of this injury reflected results,
often poor, obtained when utilizing early generation implants and surgical techniques. In
addition, a number of studies have reported the results of humeral shaft fractures managed
with intramedullary nails. Although controversy remains, we believe the publications of
McCormack, et.al.1 and Chapman, et.al.2 have concluded in a prospective randomized comparison
fashion that plating now produces a superior outcome to intramedullary nailing in humeral
shaft fractures. Very few existing publications3-7 compare conservative versus operative
treatment of humeral shaft fractures. Of these, only one (Nast-Kolb, et.al.3) does so in a
prospective manner. Even this study included patients with various associated and possibly
confounding injuries and treatment selection was not controlled or randomized in any way.
No study has ever compared the results of isolated humeral shaft fractures treated
conservatively/nonoperatively versus operatively in a prospective cohort comparison. In
addition, few studies of humeral shaft fractures have utilized any form of validated
functional outcome measures when drawing conclusions about given treatment options.
B. Hypothesis or Objective The objective of this study is to determine whether isolated
humeral shaft fractures are optimally treated with internal fixation or bracing.
Specific Aim #1 To determine the healing rates between operative and non operative management
in a prospective study.
Hypothesis 1. Nonunion and malunion will be higher in patients managed conservatively.
Specific Aim #2 The DASH outcomes of patients treated operatively will return to pre-injury
status faster than non operative treatment.
Hypothesis 2.Patients with an isolated humeral shaft fracture that is operatively stabilized
will have improved functional outcome scores as measure by the DASH score than patients
treated conservatively.
Specific Aim #3 To determine VAS derived pain scores. Hypothesis 3. Patients treated with
operative fixation will have decreased pain scores as measure by a VAS at 2 and 6 weeks than
those managed conservatively.
Specific Aim #4 To determine overall complication rates between the two groups. Hypothesis 4.
Complication rates of infection and iatrogenic neurologic injury will be higher in patients
treated operatively.
C. Research Strategy We believe the need for this study is further supported by published
data obtained in a retrospective review of two hundred thirteen (213) closed humeral shaft
fractures treated operatively with plates and nonoperatively at the two Level I trauma
centers over the past five years. These findings indicate a higher malunion and nonunion rate
of statistical significance in the nonoperative group.
We are completing a pilot prospective, randomized cohort study with 62 patients enrolled and
31 in each group. We believe a large, prospective randomized study to answer the question of
the better treatment in terms of functional outcomes for the treatment of humeral shaft
fractures is needed.
This investigation will consist of a prospective, surgeon based multicenter clinical trial to
evaluate non-operative versus operative treatment of isolated humeral shaft fractures.
C1.Study Participants This investigation will consist of a prospective multicenter clinical
trial to evaluate non-operative versus operative treatment of isolated humeral shaft
fractures. We anticipate participation from multiple Level I trauma centers; each of which
has experience with similar research study designs. The PI and Co-investigators all
participated in the pilot study, along with investigators from 5 additional centers. The
study protocol will require IRB/HAC approval from each participating center.
Patient Recruitment and Screening When a patient from 18-65 years old presents with a humeral
shaft fracture, he or she will be screened for possible enrollment in the study using the
inclusion/exclusion criteria. If the patient is deemed appropriate by the treating surgeon,
meaning that they meet all the inclusion criteria and do not meet any exclusion criteria, the
patient will be given the consent form to read and it will be reviewed with the patient with
time allowed to answer all questions. If the patient agrees to enter the study, he or she
will sign the consent form.
Randomization The patients who provide informed consent will be randomized to one of two
treatment groups: Patients in the brace group (B) will be treated with a fracture brace and
patients randomized to the plate group (P) will be treated with open reduction and internal
fixation (ORIF) with a plate. Each arm of the study will be separately randomized via a
computer-generated number at the Data Control Center.
Assessment. The DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure will be
utilized as the functional assessment tool. As this tool has been well validated for upper
extremity injuries and has normative data, we believe it to be a good choice for this study
population. The questionnaire will be administered (we will compare operative to non
operative treatment, not to patient's baseline function) at 6 weeks, 3, 6 and 12 months
post-injury. In addition a visual analogue pain scale (VAS) will be administered at 2 weeks,
6 weeks, 3, 6 and 12 months.
C2. Treatment Patient who present with a humeral shaft fracture will initially have the same
treatment. All patients will have a closed reduction with adequate sedation in the Emergency
Department and application of a coaptation splint and sling. If they meet the
inclusion/exclusion criteria, they will be approached for participation in one of two
treatment groups. Informed consent will be obtained.
Patients in the operative group (P) will be scheduled for elective surgery for plate fixation
of their humeral shaft fracture within 2 weeks from date of injury. The surgical approach,
plate brand, and plate size will be at the discretion of the treating orthopaedic surgeon.
Patients in the non-operative group (B) will have clinical follow-up scheduled. A humeral
fracture brace is applied in the office. A sling is optional for patient comfort. After
fracture brace application, the patient is instructed to perform pendulum exercises for
shoulder mobility. Exercises of the elbow, wrist and hand are also encouraged. The patient is
instructed to adjust the tension of the brace twice per week and sleep in a semi-erect
position for the first six weeks. (These instructions are all standard of care for fracture
brace treatment). The fracture brace is worn until the patient has met the clinical and
radiographic healing criteria described in the protocol.
D. Research Area Although accepted standards for non-operative management of isolated humeral
shaft fractures have remained largely unchanged and unchallenged for several decades;
prospective, comparative data incorporating validated patient outcome measures is lacking.
Specifically, data comparing non-operative versus operative treatment for isolated humeral
shaft fractures has not been published. We endeavor to scientifically evaluate two different
treatments for isolated humeral shaft fractures and determine which treatment option in a
prospective study may provide better functional outcomes and less complications.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03689335 -
HUmeral Shaft Fracture FIXation Study
|
N/A |