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Absorbable Screws to Treat Anterior-Superior Iliac Spine Avulsion Fractures

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ClinicalTrials.gov Identifier: NCT03975426
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Yuxi Su, Children's Hospital of Chongqing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment
Fractures, Bone Pediatrics Procedure: open reduction and internal fixation with fixation by absorbable screws

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.

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Absorbable Screws to Treat Children and Adolescents With Anterior-Superior Iliac Spine Avulsion Fractures
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.
Procedure: 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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • avulsion fracture of the ASIS
  • new fractures

Exclusion Criteria:

  • old avulsion fractures
  • delayed fractures
  • multiple fractures.

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Responsible Party: Yuxi Su, Vice-Dean of the Pediatric orthopedic, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03975426     History of Changes
Other Study ID Numbers: CHCMU-Yuxisu002
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Avulsion
Wounds and Injuries