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

NCT ID: NCT05042297

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-09
• Study Completion Date: 2021-07-15

Brief 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.

Conditions

Evaluation of PR Fixation in Tile B2 and C1 Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combined Posterior and anterior ring fixation

Posterior ring fixation via a single posterior Sacroiliac screw or two Iliac wing plates. While anterior ring fixation was via a single para-symphyseal plate in Tile B2 injuries. Meanwhile, we used double superior and anterior symphyseal plates in Tile C1 injuries.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Isolated Posterior ring fixation

We used either two Sacroiliac screws in S1 and S2, or two Iliac wing plates.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Islam Moussa

Assistant lecturer of orthopedic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr K. Mahmoud, Professor

Role: PRINCIPAL_INVESTIGATOR

no funding recieved

Locations

Ain Shams University

Cairo, Abassia, Egypt

Countries

Egypt

References

Schmal H, Froberg L, S Larsen M, Sudkamp NP, Pohlemann T, Aghayev E, Goodwin Burri K. Evaluation of strategies for the treatment of type B and C pelvic fractures: results from the German Pelvic Injury Register. Bone Joint J. 2018 Jul;100-B(7):973-983. doi: 10.1302/0301-620X.100B7.BJJ-2017-1377.R1.

Reference Type: BACKGROUND

PMID: 29954203 (View on PubMed)

Pohlemann T, Stengel D, Tosounidis G, Reilmann H, Stuby F, Stockle U, Seekamp A, Schmal H, Thannheimer A, Holmenschlager F, Gansslen A, Rommens PM, Fuchs T, Baumgartel F, Marintschev I, Krischak G, Wunder S, Tscherne H, Culemann U. Survival trends and predictors of mortality in severe pelvic trauma: estimates from the German Pelvic Trauma Registry Initiative. Injury. 2011 Oct;42(10):997-1002. doi: 10.1016/j.injury.2011.03.053. Epub 2011 Apr 22.

Reference Type: RESULT

PMID: 21513936 (View on PubMed)

Hauschild O, Strohm PC, Culemann U, Pohlemann T, Suedkamp NP, Koestler W, Schmal H. Mortality in patients with pelvic fractures: results from the German pelvic injury register. J Trauma. 2008 Feb;64(2):449-55. doi: 10.1097/TA.0b013e31815982b1.

Reference Type: RESULT

PMID: 18301214 (View on PubMed)

Osterhoff G, Ossendorf C, Wanner GA, Simmen HP, Werner CM. Percutaneous iliosacral screw fixation in S1 and S2 for posterior pelvic ring injuries: technique and perioperative complications. Arch Orthop Trauma Surg. 2011 Jun;131(6):809-13. doi: 10.1007/s00402-010-1230-0. Epub 2010 Dec 28.

Reference Type: RESULT

PMID: 21188399 (View on PubMed)

Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae.

Reference Type: RESULT

PMID: 21857421 (View on PubMed)

Other Identifiers

FMASU MD 272/2019

Identifier Type: -

Identifier Source: org_study_id