Combined Ring (APR) Fixation Vs Posterior Ring Fixation in Tile B2 and C1 Pelvic Ring Injuries
Condition: Evaluation of PR Fixation in Tile B2 and C1 Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim for surgical treatment of unstable Tile B2 & C1 pelvic ring injuries is an anatomical
      reduction to allow early weight-bearing, pain relief and to prevent future pelvic asymmetry.
      So, we usually used combined posterior & anterior ring fixation, relying on the fact that
      anterior pelvic ring adequate reduction and fixation better augment posterior ring fixation
      and enhance overall pelvic stability. However, anterior ring fixation requires a second
      incision with a longer operation time and more blood loss. The main disadvantage of the
      second incision is the higher risk of wound infection, either superficial or deep, which
      questions its necessity and raises concerns about the possibility of isolated posterior ring
      fixation in managing Tile B2 & C1 pelvic ring injuries with good outcomes.

      The fundamental algorithm was the questionable need for additional anterior ring fixation in
      managing Tile B2 and C1 pelvic ring injuries combined with posterior ring fixation, whether
      the incidence of postoperative complications, radiological and clinical outcomes differed
      between these two groups. After reviewing the literature, we found a lack of knowledge in the
      prospective assessment of such outcomes between the two fixation groups. So, This RCT aims to
      reach a satisfactory result and prove or deny the questionable need for anterior ring
      fixation in managing Tile B2 and C1 pelvic ring injuries. Our hypothesis was that PR fixation
      is at least as good as APR fixation.
    

Detailed description: 
      Type of Study: Prospective randomized controlled clinical trial Randomization technique:
      Block Randomization. Study Setting: The operations were held in Ain Shams university
      hospitals. Study Period: From 2019 till 2020.

      Study Population:

      Inclusion Criteria:

      Tile B2 and C1 pelvic ring injuries Nakatani zone II pubic rami fractures with intact
      inguinal ligament Age between 16-60 years old Recent pelvic ring injuries less than three
      weeks

      Exclusion Criteria:

      Tile A pelvic ring injuries Nakatani zone I & III pubic rami fractures neglected pelvic ring
      injuries exceeding three weeks Age less than 16 years and older than 60 years

      Sampling Method: convenient sample. Sample Size: 40 feet subdivided randomly via Block
      Randomization into 2 groups, 20 feet for each group.

      Group A: Patients treated by combined posterior and anterior ring fixation Group B: Patients
      treated by posterior ring fixation alone

      Ethical Considerations: were followed by obtaining the hospital Research Ethics Committee
      approval and written informed consents from the patients.

      Study Tools:

      The patients were evaluated by the following: -

      All patients were subjected to:

      I. Pre-operative:

      Written consent.

      Complete ATLS protocol:

      Primary survey: airway, breathing, circulation and disability with complete exposure,
      including: CXR and pelvis anteroposterior view Secondary survey: head to toe examination,
      complete cervical clinical and radiological clearance and detailed AMPLE history

      Detailed history:

      History-taking included age, mode of trauma, physiological status, haemodynamics, associated
      internal organ injuries, medical comorbidities and detailed surgical history.

      Complete Orthopaedic examination:

      Full and thorough examination of the patient was done from head to toes with complete
      inspection, palpation and range of motion examination of the whole body, together with
      detailed neurovascular examination of both lower limbs.

      X-Rays pre and post-operative Preoperative: to assess the fracture pattern, location and for
      surgical planning.

      Postoperatively: to assess the quality of reduction immediate postoperative and at each
      follow up visit (two weeks, six weeks, three months, six months and one year) to follow up
      union rate, fixation failure, secondary dislocation and secondary loss of reduction.

      CT pelvis preoperative will be done to accurately describe fracture pattern, identify occult
      radiological instability and more comprehensive surgical planning.

      Evaluation of the patients by clinical Majeed pelvic scoring system

      II.Operative technique Group A: combined posterior and anterior ring fixation Group B:
      Isolated Posterior ring fixation

      III. Postoperative management and evaluation:

      We followed a partially assisted weight-bearing protocol for six weeks for both groups (using
      axillary or forearm crutches that take about 50% of the body weight through the injured lower
      extremity). In addition, we did x-ray films & neurovascular examination postoperatively.

      Follow-up visits were at two weeks, six weeks, three months, six months & 1-year
      postoperative.

      We performed radiological and clinical assessments: Radiological using Matta & Tornetta
      radiological principles via plain x-ray pelvis showing both hips: anteroposterior, inlet and
      outlet views & CT pelvis if available; we evaluated five criteria on X-ray films
      postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal
      translation, sagittal rotation, and gapping of the sacroiliac joint; according to the grading
      of Matta and Tornetta, we classified the results into Excellent (less than or equal 4 mm),
      Good (4-10 mm), Fair (10-20 mm), and Poor (more than 20 mm). In addition, clinical assessment
      by Majeed pelvic scoring system evaluated and calculated at each follow-up visit with the
      mean value presented, Postoperative complications and need for another operation were
      evaluated.

      In week two, we encouraged passive and active-assisted hip ROM. Then we started an unassisted
      weight-bearing and physiotherapy program to strengthen abductors and quadriceps muscles in
      week six. While complete full weight-bearing and return to work were after three months.
      After six months, a full radiological and clinical assessment were done + return to
      pre-injury mobility status and athletic sports. Finally, after one year, we did clinical and
      radiological reevaluation.

      IV- Statistical analysis of data.

      V- Outcome measures of interest:

      Primary outcomes: radiological (using Matta & Tornetta radiological principles) & clinical
      outcomes (using the Majeed pelvic scoring system), and postoperative complications.

      Secondary outcomes: operative time, amount of blood loss, intraoperative assessment of
      reduction, need for another operation, length of hospital stay, ability to weight bear
      postoperative, and pain control metrics.
    

Intervention name(s): Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention
Intervention type(s): Procedure
Intervention description(s): Reduction of the posterior ring was either closed reduction in SI joint dislocations & fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach. Anterior pelvic ring reduction and fixation in the combined APR fixation group was done via the classic Pfannenstiel approach or extension more lateral & completing the anterior intrapelvic approach. Fixation was via pubic rami plating.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 40 patients with Tile B2 & C1 injuries between March 2019 and July 2020 that met our inclusion criteria. The independent doctor allocated the 40 cases to two groups: Group A (20 cases): combined posterior and anterior ring fixation (APR fixation group), group B (20 cases): isolated posterior ring fixation (PR fixation group).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tile B2 and C1 pelvic ring injuries; Posterior ring fixation; Sacroiliac Screw; Radiological outcome; Majeed Pelvic Score