MedTrace Logo

Combined Ring (APR) Fixation Vs Posterior Ring Fixation in Tile B2 and C1 Pelvic Ring Injuries

NCT05042297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-13

No results posted yet for this study

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.

Conditions

  • Evaluation of PR Fixation in Tile B2 and C1 Injuries

Interventions

PROCEDURE

Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Amr K. Mahmoud, Professor · no funding recieved

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-09
Primary Completion
2020-07-07
Completion
2021-07-15

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05042297 on ClinicalTrials.gov