- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975426
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
Status
Completed
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Fractures, Bone
-
Jen-Chieh LaiCompleted
-
Lawson Health Research InstituteCompleted
-
Shahid Beheshti University of Medical SciencesRecruiting
-
Brigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Active, not recruitingFractures | Bone Density | Bone HealthUnited States
-
Artur Salgado SANAMSARecruitingBone Loss | Bone Fractures | Bone Defects | Bone GraftPortugal
-
AO Innovation Translation CenterActive, not recruitingLong Bone FracturesCanada, United States, Australia, Croatia, Chile, Spain, Venezuela, Ghana, Pakistan, Germany, India, Greece
-
University Hospital, Clermont-FerrandTerminated
-
IlluminOss Medical, Inc.CompletedHumerus Fracture Metastatic Bone DiseaseUnited States
-
Centre Hospitalier Universitaire Saint PierreRecruiting
-
McMaster UniversityMcMaster Surgical AssociatesCompleted
Clinical Trials on open reduction and internal fixation with fixation by absorbable screws
-
Ain Shams UniversityCompleted
-
University of Maryland, BaltimoreCompletedAcetabular FractureUnited States
-
Ankara UniversityRecruitingMetastatic Cancer | Bone Metastases | Pathologic FractureTurkey
-
Samer youssef mansour meglaaAssiut UniversityActive, not recruiting
-
McGill University Health Centre/Research Institute...Orthopaedic Trauma AssociationCompletedDistal Radius FracturesCanada
-
University of MinnesotaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedFemoral Neck FracturesUnited States
-
McGill University Health Centre/Research Institute...Canadian Orthopaedic Trauma SocietyCompleted
-
UMAE Hospital de Traumatologia y Ortopedia de PueblaCompletedClosed Fracture of Shaft of Clavicle
-
Spectrum Health HospitalsWithdrawnAnkle FracturesUnited States
-
King Edward Medical UniversityCompletedMandibular Fractures