Operative Versus Nonoperative Treatment of Humeral Shaft Fractures: A Prospective Cohort Comparison Study
Condition: Closed Fracture of Shaft of Humerus
MeSH terms: Fractures, Bone; Fractures, Closed
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18 to 65 years with a humeral shaft fracture.
      
Keywords: humerus; fracture; operative treatment; non-operative treatment