Fractures, BoneNCT03975426
Absorbable Screws to Treat Anterior-Superior Iliac Spine Avulsion Fractures
An observational study of Fractures, Bone and Pediatrics, run by Children's Hospital of Chongqing Medical University.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Fractures, Bone, Pediatrics
- What is being tested?
- open reduction and internal fixation with fixation by absorbable screws
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- avulsion fracture of the ASIS
- new fractures
Who cannot join
- old avulsion fractures
- delayed fractures
- multiple fractures.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fractures, Bone, Pediatrics
- Being tested
- open reduction and internal fixation with fixation by absorbable screws
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and internal fixation with fixation by absorbable screwsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: open reduction and internal fixation with fixation by absorbable screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Academy of Othopaedic Surgeons lower limb and hip scores
Stiffness of the Hip 0-5 scores, higher values represent a better outcome
Measured: 6th month
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
Measured: 6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Walking 0-5 scores ,higher values represent a better or worse outcome
Measured: 6th month
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
Measured: 6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
bed rest 0-5 scores,higher values represent a better or worse outcome
Measured: 6th month
American Academy of Othopaedic Surgeons lower limb and hip scores
Moving 0-5 scores,higher values represent a better or worse outcome
Measured: 6th month
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
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jan 2009
- Primary completion31 Dec 2016
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975426
- Sponsor's protocol ID
- CHCMU-Yuxisu002
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Absorbable Screws to Treat Children and Adolescents With Anterior-Superior Iliac Spine Avulsion Fractures
- ClinicalTrials.gov ID
- NCT03975426
- Acronym / sponsor ID
- CHCMU-Yuxisu002
- Conditions
- Fractures, Bone, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: open reduction and internal fixation with fixation by absorbable screwsreceived open reduction and internal fixation with fixation by absorbable screws. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- avulsion fracture of the ASIS
- new fractures
Key exclusion criteria (3 listed)
- old avulsion fractures
- delayed fractures
- multiple fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open reduction and internal fixation with fixation by absorbable screwsGroup 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. | Procedure or surgery | absorbable screws |
Primary outcome
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Pediatrics, run by Children's Hospital of Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Academy of Othopaedic Surgeons lower limb and hip scores (time frame: 6th month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.