Sharp AngleNCT01285154
Modified Triple Osteotomy for Acetabular Dysplasia
An observational study of Sharp Angle and Center Edge Angle, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Sharp Angle, Center Edge Angle, Femoral Head Extrusion Index
- How many people
- 2 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Jun 2011
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Young adults and adolescents underwent triple innominate osteotomy for symptomatic acetabular dysplasia in our institution
Who may be able to join
- Symptomatic acetabular dysplasia in adolescent or young adult
- Closed triradiate cartilage
- Minor coxarthrosis with Tonnis grades at 1 or 2
Who cannot join
- High subluxation or complete dislocation of the hip joint
- Severe osteoarthrosis
- Combined with proximal femoral osteotomy that changed the femoral neck shaft angle (such as varus or valgus osteotomy)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
About this study
Official title: Modified Triple Osteotomy for Acetabular Dysplasia - A Modified Technique for Better Femoral Head Medialization and Coverage
Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. The investigators modified the technique with two anterior incisions and ramus cuts close to inferior acetabulum. The purpose of this study is to compare these two techniques in femoral head coverage
- Conditions
- Sharp Angle, Center Edge Angle, Femoral Head Extrusion Index, Center Head Distance Discrepancy
- Keywords
- Hip dysplasia, Triple Osteotomy, Femoral Head Coverage, Femoral Head Medialization
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Steel Triple Osteotomy | Traditional technique | |
| Modified Triple Osteotomy | Modified technique |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sharp AngleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Chen Li, M.D., Study chair, National Taiwan University Hospital, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285154
- Sponsor's protocol ID
- 201012045RC
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2011
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Triple Osteotomy for Acetabular Dysplasia - A Modified Technique for Better Femoral Head Medialization and Coverage
- ClinicalTrials.gov ID
- NCT01285154
- Acronym / sponsor ID
- 201012045RC
- Conditions
- Sharp Angle, Center Edge Angle, Femoral Head Extrusion Index, Center Head Distance Discrepancy
- Keywords
- Hip dysplasia, Triple Osteotomy, Femoral Head Coverage, Femoral Head Medialization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 27 Jan 2011 (estimated)
- 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.
Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. The investigators modified the technique with two anterior incisions and ramus cuts close to inferior acetabulum. The purpose of this study is to compare these two techniques in femoral head coverage
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Steel Triple Osteotomy | – | –Traditional technique |
| Modified Triple Osteotomy | – | –Modified technique |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young adults and adolescents underwent triple innominate osteotomy for symptomatic acetabular dysplasia in our institution
Key inclusion criteria (3 listed)
- Symptomatic acetabular dysplasia in adolescent or young adult
- Closed triradiate cartilage
- Minor coxarthrosis with Tonnis grades at 1 or 2
Key exclusion criteria (3 listed)
- High subluxation or complete dislocation of the hip joint
- Severe osteoarthrosis
- Combined with proximal femoral osteotomy that changed the femoral neck shaft angle (such as varus or valgus osteotomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
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.
Yi-Chen Li, M.D. study chair
National Taiwan University Hospital, Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sharp Angle and Center Edge Angle, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chen Li, M.D. (886-2-23123456 ext. 62515, atcg0125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Apr 2011.