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Completed

NCT Number: NCT03975426

Absorbable Screws to Treat 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.

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Key information

Conditions

Fractures, Bone Pediatrics Wounds and Injuries

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • avulsion fracture of the ASIS
  • new fractures

Exclusion criteria

  • old avulsion fractures
  • delayed fractures
  • multiple fractures.

Treatment and study plan

open reduction and internal fixation with fixation by absorbable screws

Procedure

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2018
First posted
Jun 5, 2019
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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