Absorbable Screws to Treat Anterior-Superior Iliac Spine Avulsion Fractures

Pediatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975426
• Other study ID #: CHCMU-Yuxisu002
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: January 1, 2018

Study information

• Verified date: June 2019
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 1, 2018
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• avulsion fracture of the ASIS

• new fractures

Exclusion Criteria:

• old avulsion fractures

• delayed fractures

• multiple fractures.

Related Conditions & MeSH terms

• Fractures, Bone
• Pediatrics

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Outcome

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