Absorbable Screws to Treat Anterior-Superior Iliac Spine Avulsion Fractures

June 4, 2019 updated by: Yuxi Su, Children's Hospital of Chongqing Medical University

The Use of Absorbable Screws to Treat Children and Adolescents With Anterior-Superior Iliac Spine Avulsion Fractures

There is some debate over the best treatment for anterior-superior iliac spine (ASIS) avulsion fractures although conservative treatment can be applied when there are no neurological symptoms. Open reduction and internal fixation can be performed for dislocations exceeding 1.5 cm, or in patients requiring a short period of convalescence, although a second operation is subsequently required to extract osteosynthetic material. In this paper, we introduce the use of absorbable screws as a new fixation material for the second round of surgery.

Study Overview

Detailed Description

To investigate the feasibility of absorbable screws as a new fixation material for the treatment of ASIS avulsion fractures in children and adolescents.The investigator plan to retrospectively analyzed 59 patients diagnosed with ASIS avulsion fractures in our hospital between Jan 2009 and Dec 2016. These patients were divided into two groups: group A (conservative group) and group B (absorbable screws). Group A received conservative therapy involving bed rest with the affected lower extremity positioned with the hip and knee in flexion to ensure minimal tension of the muscles attached to the ASIS avulsion fracture. Group B received open reduction and internal fixation with fixation by absorbable screws. Six weeks and three months after treatment, all patients were assessed for range of motion (ROM) and by X-ray as they returned to activity. One week after treatment, the American Academy of Orthopaedic Surgeons (AAOS) lower limb and hip score was used to evaluate hip function; the same scores were also determined during follow-up at 1, 3, 6 and 12 months postoperatively.

Study Type

Observational

Enrollment (Actual)

59

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study was a retrospective review of one center's experience of treating avulsion fractures of the ASIS in children and adolescents. All patients were evaluated and treated in the same hospital.

Description

Inclusion Criteria:

  • avulsion fracture of the ASIS
  • new fractures

Exclusion Criteria:

  • old avulsion fractures
  • delayed fractures
  • multiple fractures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conservative group
received conservative therapy involving bed rest with the affected lower extremity positioned with the hip and knee in flexion to ensure minimal tension of the muscles attached to the ASIS avulsion fracture.
absorbable screws
received open reduction and internal fixation with fixation by absorbable screws.
Group A received conservative therapy involving bed rest with the affected lower extremity positioned with the hip and knee in flexion to ensure minimal tension of the muscles attached to the ASIS avulsion fracture. Group B received open reduction and internal fixation with fixation by absorbable screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
Stiffness of the Hip 0-5 scores, higher values represent a better outcome
6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
swelling of the Hip 0-5 scores,higher values represent a better or worse outcome
6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
Walking 0-5 scores ,higher values represent a better or worse outcome
6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
Going up and goingdown stairs 0-5 ,higher values represent a better or worse outcome
6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
bed rest 0-5 scores,higher values represent a better or worse outcome
6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
Moving 0-5 scores,higher values represent a better or worse outcome
6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Time Frame: 6th month
wear socks wear socks Wearing socks 0-5 scores,higher values represent a better or worse outcome
6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CHCMU-Yuxisu002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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