Distal Radial Fractures in the Late Middle Aged
Condition: Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures
Study type: Interventional

Summary: 
      Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of
      the bones making up the wrist joint, and is typically the site of injury in a broken wrist.
      Methods of treating a broken radius include placing the wrist in a cast for 6 weeks
      (conservative management) or receiving surgery. Surgery allows for earlier movement of the
      wrist and return to activity, while being placed in a cast is less invasive than surgery.

      Surgery to fix these fractures has become more common; however there is little agreement
      about who should receive surgery and who should be placed in a cast to heal. The goal of this
      study is to compare outcomes between people aged 55-70 who have broken their wrist and had
      surgery, and those who received a cast.

      Procedures: Participants in this study will be randomly assigned to one of two study groups
      within 1 week of injury at their first clinic visit with the surgeon.

      Patients in Group A (surgical management) will continue with casting for a total of 6 weeks,
      as indicated by the surgeon.

      Patients in Group B (conservative management) will receive surgery, and the attending surgeon
      will determine the best fracture fixation method for the wrist.

      The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after
      the initial injury. At each assessment, the wrist will be examined and participants will be
      asked to fill in some questionnaires about health, pain, wrist function, and satisfaction
      with the wrist. An X-ray will also be performed on the wrist to assess bone healing.
      Information from each visit will be used to determine how participants are doing and to
      compare the 2 study groups.
    

Detailed description: 
      BACKGROUND

      Distal radius fractures (DRF) are the most common upper extremity fractures in late
      middle-aged patients. This injury creates significant disability rendering a person without
      full use of the affected hand and wrist for 6 weeks or more with potential long-term
      consequences of post-traumatic wrist arthritis and contracture. Over the past 20 years,
      surgical management of DRF has increased substantially. Despite the frequency of these
      fractures, there is little comparative evidence to guide surgical decision-making for this
      population.

      Although surgical management improves radiographic outcomes, it does not appear that
      radiographic outcomes correlate well with patient reported outcomes (pain and function). As
      there are significant health resource implications of surgical versus conservative
      management, it is imperative that we determine when operative fixation is needed. Further, as
      our population is aging, the number of patients with DRF will increase substantially in the
      late to middle-aged and elderly adults.

      For subjects under 55 years of age, surgical management is often undertaken to allow early
      mobility and facilitate return to work and activity, even in the presence of equivocal
      clinical outcomes between management approaches. Conversely, in those who are older than 70
      years, conservative management is more common due to lower patient demands.

      However, the American Academy of Orthopedic Surgeons issued clinical practice guidelines that
      could not make evidence based treatment recommendations for patients aged 55 to 70 years with
      DRFs. Thus, there is no current available evidence comparing patient outcomes between
      surgical and conservative management in this age group. The overall goal of RIST will be to
      compare outcomes between patients aged 55-70 years who receive surgical or conservative
      management. Our primary outcome will be a clinical measure (patient-reported or
      performance-based) rather than radiographic alignment.

      Because evidence focused around this age group is sparse, we will first conduct a pilot trial
      to clarify eligibility criteria, outcome measure selection, sample size requirements, and
      recruitment and retention rates. In 2013, 610 patients aged 55-70 years with DRFs were seen
      in Edmonton emergency departments and 314 inpatients aged 55-70 years with DRFs were
      discharged from all hospitals in the greater Edmonton area.

      OBJECTIVES

      Primary objective: To determine the feasibility of conducting a definitive RCT comparing
      surgical versus conservative management in 55-70 year old patients with DRF. This study will
      examine:

        1. Recruitment and eligibility rates

        2. Treatment fidelity (the ability to deliver the intervention in the way that it was
           intended) through measurement of patient crossovers from non-operative management to
           operative fixation within the first year of fracture

        3. Outcomes and outcome measures to determine most appropriate measure and sample size
           required

        4. Retention rate at 1 year.

      Secondary objective: To compare clinical and radiographic outcomes of surgical and
      conservative management for 55-70 year old patients with DRF over the first year
      post-fracture using:

        1. Patient-Rated Wrist Evaluation (PRWE) Questionnaire - currently deemed primary outcome
           measure

        2. Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

        3. Patient satisfaction regarding cosmesis using a visual analogue scale (VAS)

        4. Grip strength using a hand-held dynamometer

        5. Wrist Range of Motion (ROM) using standardized goniometry

        6. Radiographic measures (dorsal angulation, ulnar shortening, articular steps and gaps.)

      EXPERIMENTAL PROTOCOL

      Study Design: Parallel RCT with stratification by surgeon using computer generated unequal
      randomization blocks. Following screening, consent and baseline evaluation, the research
      coordinator will open sequentially numbered envelopes assigned to the treating surgeon.
      Participants will be randomized to operative fixation or cast treatment.

      Selection Criteria: This pilot RCT will enroll 55 to 70 year old subjects with isolated
      intra- or extra-articular displaced DRFs who present to the Sturgeon Community Hospital (SCH)
      for medical care under 1 of 5 fellowship-trained upper-extremity orthopaedic surgeons.
      Eligible subjects will present with the following radiographic findings before reduction:
      dorsal angulation ≤20 degrees, ulnar shortening ≤5 mm relative to the contralateral side
      (subjects will have contralateral wrist xrays), articular step ≤2 mm after initial post
      reduction and gap ≤5 mm. These parameters were chosen as they meet accepted criteria for
      distal radius fracture instability, but are still correctable by osteotomy if the fracture
      heals with this degree of mal-alignment.

      Patients with volar Barton fractures, radiocarpal subluxation or dislocation, open fractures,
      ipsilateral upper extremity injuries, bilateral fractures or multiple traumas will be
      excluded. Those with previous injury or fracture to the contralateral wrist, or those not fit
      for surgical management will also be excluded.

      Screening and Enrollment: Patients will be screened for study eligibility at their initial
      clinic visit by the attending surgeon and research coordinator within 1 week of injury. The
      Research Coordinator will track reasons for refusal from patients who do not consent to
      participate as well as exclusions by the surgeons based on patient or fracture
      characteristics. Those patients who agree to participate will be consented and enrolled by
      the Research Coordinator. The baseline evaluation will consist of completion of a
      demographics/screening form form (age, gender, mechanism of injury, past and current medical
      status, work and activity demands) and PRWE and DASH questionnaires. All data will be
      collected using standardized forms and entered into a password-protected database.

      Intervention: Following the baseline evaluation, the subject will be randomized to receive
      either surgical or conservative management. Those with conservative management will continue
      with casting for a total of 6 weeks. For those randomized to operative fixation, the
      attending surgeon will determine the optimal fracture fixation method for the fracture
      pattern.

      At each follow-up visit, the surgeon, in conjunction with the patient, will evaluate outcomes
      in the conservatively managed group to determine if corrective osteotomy is indicated based
      on the patient's pain, weakness and acceptance of clinical deformity. If a corrective
      osteotomy is required at any time point in the study, this will be considered as failure of
      non-operative treatment. This approach is being used in the feasibility trial to assess the
      current selection criteria to determine if they require revision prior to the definitive RCT.

      Follow-up Evaluations: Two weeks after randomization, the research coordinator will contact
      participants by telephone to complete the PRWE and Dash questionnaires, and ask about any
      complications related to their injury. Participants will return to clinical follow-up at 6
      weeks, 3 months, 6 months and 12 months at the SCH using the same validated measures.
      Starting at the 6 week assessment, wrist ROM (flexion, extension, pronation, supination,
      ulnar and radial deviation) using a goniometer and grip strength using a hand-held
      dynamometer will also be evaluated by the research coordinator. Radiographic evaluation of
      dorsal angulation, ulnar shortening, articular steps and gaps and complications and adverse
      events will also be recorded at each visit. At 1-year follow-up, patient satisfaction with
      their clinical outcome will be assessed using a PRWE and DASH questionnaires and a VAS for
      determining satisfaction with wrist cosmesis.

      Outcomes and Outcome Measures: Although radiographic parameters will be collected and
      measured, the primary outcomes will be the clinical measures: patient-reported wrist specific
      outcomes (PRWE), patient reported upper extremity function (DASH) and wrist ROM and grip
      strength.

        1. Patient-Rated Wrist Evaluation (PRWE) Questionnaire - The PRWE is a brief, reliable and
           valid 15-item tool used to assess patient-rated wrist pain and disability during
           activities of daily living. Subjects rate their pain and function from 0-10 in two
           different subscales: pain subscale and function subscale. The minimally clinically
           important difference (MCID) for the PRWE is 17 points on a 0-100 score.

        2. Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire - The DASH is a valid
           and reliable 30-item scale that assess physical function and symptoms in subjects with
           upper limb musculoskeletal issues. It has three modules: disability and symptom
           (mandatory), work (optional) and sports/performing arts (optional). The MCID for the
           DASH is 13 points on a 0-100 score.

        3. Patient satisfaction - Patient satisfaction with their outcome is in part being answered
           with the PRWE and DASH questionnaires, since both assess pain and function. However,
           because we are comparing surgical versus conservative treatment, it is also important to
           evaluate how satisfied the subjects are with the cosmesis of their wrist after
           treatment. Conservative treatment may leave a mal-aligned wrist and surgical treatment
           will leave scars and the acceptability of either may affect the willingness of the
           subject to agree with either treatment choice. Therefore, we will use a visual analogue
           scale to measure how satisfied the subject is with the cosmesis of the wrist after
           treatment (0- not satisfied at all to 10- completely satisfied).

        4. Grip strength - Peak values of grip strength in both hands will be measured with a
           hand-held dynamometer. Absolute values and percentage of their contralateral side will
           be compared between the two groups. The MCID for grip strength after DRF is 6.5
           kilograms or 20%.

        5. Wrist Range of Motion (ROM) - Active and passive ROM of wrist flexion, extension, ulnar
           deviation, radial deviation, pronation and supination will be assessed using goniometry.
           Absolute values and percentage of their contralateral side will be compared between
           groups. No MCID have been established for wrist ROM, so we will evaluate differences in
           ROM and correlate those with both grip strength and patient reported outcomes to
           determine what differences in ROM appear to affect outcomes, if any.

        6. Radiographic Parameters: Dorsal angulation, ulnar shortening, articular steps and gaps
           will be measured at initial presentation and when fracture is healed (6 weeks) and at
           the end of the study period (12 months).

      Sample Size: For this feasibility trial, 50 participants (25/group) will be enrolled. This
      will allow us to assess subject recruitment, treatment fidelity and retention. Based on our
      findings, we will refine our selection criteria as necessary for the definitive RCT. This
      pilot evaluation will provide for calculation of the sample size for the definitive RCT based
      on confirmation of the primary outcome measure. Although 50 participants will likely be
      inadequate to detect significant group differences, it should be adequate to determine if
      MCID occur in clinical outcomes between groups.

      Analysis: The analysis of this feasibility component of the RIST trial will be 2-pronged to
      prepare for the definitive RCT:

        1. Process Evaluation: This process evaluation will be a descriptive analysis that will
           assist us in refining eligibility criteria, recruitment rates, treatment fidelity and
           determine study timelines prior to undertaking a large scale RCT.

           Recruitment, enrollment and retention rates: All 55-70 year old DRF patients presenting
           at the SCH will be screened so that eligibility, recruitment and retention rates can be
           assessed. We will also evaluate recruitment methods to determine the proportion of
           patients 1) willing to participate and 2) appropriate for randomization.

        2. Treatment Fidelity: We will assess failure of allocation to treatment by examining the
           numbers of patients that withdraw post randomization or cross over to surgical
           management within the first post-fracture year. This will determine if selection
           criteria require further refinement.

      Intervention Evaluation: Our secondary objective is to compare outcomes between randomized
      groups. T-tests and repeated measures analysis of variance (ANOVA) will be used with
      continuous variables and chi square tests will be performed on categorical variables.

      Outcome Selection: We believe that the PRWE will be the most responsive measure as it is
      patient-reported wrist specific pain and function. However, we will also evaluate the DASH,
      cosmesis satisfaction (VAS) and the performance-based measures of grip strength and wrist
      ROM. Radiographic parameters will not be considered as primary outcomes because previous work
      has suggested the clinical and radiographic parameters are not well-correlated in DRF.

      Sample Size Calculation: The intervention analysis will also allow us to determine if we
      should perform a superiority or inferiority RCT. If there are no MCID detected in the pilot
      study (expected), the definitive RCT will be powered as a non-inferiority trial (i.e. similar
      clinical outcomes can be achieved with surgical or conservative management in this age
      group). If MCID are found in clinical measures, the definitive RCT will be powered as a
      superiority trial (e.g. surgical fixation is better than conservative treatment).

      Expected Outcome: This proposed pilot study is important for assessing the feasibility of
      conducting a definitive RCT so that potential challenges can be addressed prior to commencing
      the larger-scale trial. The pilot data generated will be used to develop a grant proposal for
      an adequately-powered definitive RCT. However, we believe that the pilot study will be
      appropriate for presentation and publication in a peer-reviewed journal.

      The RIST pilot and ensuing RCT will lead to improved management of wrist fractures and will
      address a gap in the current evidence base. The level 1 evidence generated from the
      definitive RCT will be published in peer-reviewed journals and presented at national and
      international meetings.
    

Intervention name(s): Surgical intervention; Conservative management; cast
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Surgical management of radial fracture; Immobilized/cast for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment