Congenital Hip DysplasiaNCT06209255
Pelvic Osteotomy Of The Total Hip Replacement
An observational study of Congenital Hip Dysplasia and Hip Osteoarthritis, run by Van Bölge Eğitim ve Araştırma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to learn about the outcomes in the previously operated patient and whether pelvic bone rearrangement surgery was a success. The main question it aims to answer is: Should the investigators perform pelvic rearrangement surgery on a patient if there's not enough bone stock to accomplish the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hip Dysplasia, Hip Osteoarthritis
- What is being tested?
- Pelvic Osteotomy - Ganz Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2020to 11 Aug 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Since this is a single-case observational study, a population description could not be made.
Who may be able to join
- Previously Replaced Total Hip
- Minimum 1-year follow-up
- 18-45 years, both sexes
- otherwise healthy
Who cannot join
- Any debilitating disorder
- Neurological or genetic disorders
- Pediatric or geriatric age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Report: Treatment of Hip Instability After Total Hip Replacement With Pelvic Osteotomy Using A Modified Stoppa Approach
This observational study aims to learn about the outcomes in the previously operated patient and whether pelvic bone rearrangement surgery was a success.
The main question it aims to answer is:
- Should the investigators perform pelvic rearrangement surgery on a patient if there's not enough bone stock to accomplish the exchange of the components?
As the research started the participant was asked to attend outpatient clinics regularly and keep in touch. The investigators were able to observe the outcomes and closely explore probable risks for failure.
Read the detailed description
A 56-year-old female patient had a hip operation one year previously and experienced her first dislocation two months postoperatively. The patient underwent closed reduction three times. The patient presented to us due to a fourth hip dislocation that had occurred one month previously. Hip X-ray images revealed acetabular component malposition, with an 80-degree inclination and 20 degrees of cup anteversion with a posterior hip dislocation. The investigators treated the patient via pelvic osteotomy, using a modified Stoppa approach to reduce acetabular inclination. The patient had no dislocation at the 2-year follow-up. At the last follow-up, the Harris Hip Score was 85.
- Conditions
- Congenital Hip Dysplasia, Hip Osteoarthritis
- Being tested
- Pelvic Osteotomy - Ganz Procedure
- Keywords
- revision hip arthroplasty
- Medical subject headings
- Hip Dislocation, Congenital, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Osteotomy - Ganz ProcedureProcedure or surgery
Ischial osteotomy was performed on the pubic arch; this was followed by iliac osteotomy, performed using Schanz screws in the iliac wing. The osteotomized acetabulum was overturned, and inclination was reduced.
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Higher scores, the better.
Measured: 3 years
Secondary outcomes (1)
Visual Analogue Score
Lower the scores, the better.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start11 Aug 2020
- Primary completion11 Aug 2021
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Congenital Hip DysplasiaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Van Bölge Eğitim ve Araştırma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Javad Mirzazada, Van Bölge Eğitim ve Araştırma Hastanesi
- Investigators
- Mehmet Coskun, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209255
- Sponsor's protocol ID
- VanBEAH
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocabiyik A, Misir A, Kizkapan TB, Yildiz KI, Kaygusuz MA, Alpay Y, Ezici A. Changes in Hip, Knee, and Ankle Coronal Alignments After Total Hip Arthroplasty With Transverse Femoral Shortening Osteotomy for Unilateral Crowe Type IV Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Nov;32(11):3449-3456. doi: 10.1016/j.arth.2017.05.044. Epub 2017 Jun 1.
PubMed 28641973Guo L, Yang Y, An B, Yang Y, Shi L, Han X, Gao S. Risk factors for dislocation after revision total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Feb;38:123-129. doi: 10.1016/j.ijsu.2016.12.122. Epub 2016 Dec 31.
PubMed 28043927Yetkin C, Yildirim T, Alpay Y, Tas SK, Buyukkuscu MO, Dirvar F. Evaluation of Dislocation Risk Factors With Total Hip Arthroplasty in Developmental Hip Dysplasia Patients: A Multivariate Analysis. J Arthroplasty. 2021 Feb;36(2):636-640. doi: 10.1016/j.arth.2020.08.043. Epub 2020 Aug 29.
PubMed 32943316Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92.
PubMed 12377909Sadhu A, Nam D, Coobs BR, Barrack TN, Nunley RM, Barrack RL. Acetabular Component Position and the Risk of Dislocation Following Primary and Revision Total Hip Arthroplasty: A Matched Cohort Analysis. J Arthroplasty. 2017 Mar;32(3):987-991. doi: 10.1016/j.arth.2016.08.008. Epub 2016 Aug 20.
PubMed 27633947Ballester Alfaro JJ, Sueiro Fernandez J. Trabecular Metal buttress augment and the Trabecular Metal cup-cage construct in revision hip arthroplasty for severe acetabular bone loss and pelvic discontinuity. Hip Int. 2010;20 Suppl 7:S119-27. doi: 10.1177/11207000100200s720. Epub 2010 May 27.
PubMed 20512783Dennis DA. Management of massive acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2003 Apr;18(3 Suppl 1):121-5. doi: 10.1054/arth.2003.50105.
PubMed 12730946DeBoer DK, Christie MJ, Brinson MF, Morrison JC. Revision total hip arthroplasty for pelvic discontinuity. J Bone Joint Surg Am. 2007 Apr;89(4):835-40. doi: 10.2106/JBJS.F.00313.
PubMed 17403808Sheth NP, Nelson CL, Springer BD, Fehring TK, Paprosky WG. Acetabular bone loss in revision total hip arthroplasty: evaluation and management. J Am Acad Orthop Surg. 2013 Mar;21(3):128-39. doi: 10.5435/JAAOS-21-03-128.
PubMed 23457063Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x.
PubMed 8163974Malahias MA, Ma QL, Gu A, Ward SE, Alexiades MM, Sculco PK. Outcomes of Acetabular Reconstructions for the Management of Chronic Pelvic Discontinuity: A Systematic Review. J Arthroplasty. 2020 Apr;35(4):1145-1153.e2. doi: 10.1016/j.arth.2019.10.057. Epub 2019 Nov 4.
PubMed 31784362
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Report: Treatment of Hip Instability After Total Hip Replacement With Pelvic Osteotomy Using A Modified Stoppa Approach
- ClinicalTrials.gov ID
- NCT06209255
- Acronym / sponsor ID
- VanBEAH
- Conditions
- Congenital Hip Dysplasia, Hip Osteoarthritis
- Keywords
- revision hip arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Van Bölge Eğitim ve Araştırma HastanesiOther government
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 17 Jan 2024 (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.
This observational study aims to learn about the outcomes in the previously operated patient and whether pelvic bone rearrangement surgery was a success.
The main question it aims to answer is:
- Should the investigators perform pelvic rearrangement surgery on a patient if there's not enough bone stock to accomplish the exchange of the components?
As the research started the participant was asked to attend outpatient clinics regularly and keep in touch. The investigators were able to observe the outcomes and closely explore probable risks for failure.
Detailed description
A 56-year-old female patient had a hip operation one year previously and experienced her first dislocation two months postoperatively. The patient underwent closed reduction three times. The patient presented to us due to a fourth hip dislocation that had occurred one month previously. Hip X-ray images revealed acetabular component malposition, with an 80-degree inclination and 20 degrees of cup anteversion with a posterior hip dislocation. The investigators treated the patient via pelvic osteotomy, using a modified Stoppa approach to reduce acetabular inclination. The patient had no dislocation at the 2-year follow-up. At the last follow-up, the Harris Hip Score was 85.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Since this is a single-case observational study, a population description could not be made.
Key inclusion criteria (4 listed)
- Previously Replaced Total Hip
- Minimum 1-year follow-up
- 18-45 years, both sexes
- otherwise healthy
Key exclusion criteria (3 listed)
- Any debilitating disorder
- Neurological or genetic disorders
- Pediatric or geriatric age
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 |
|---|---|---|
| Pelvic Osteotomy - Ganz ProcedureIschial osteotomy was performed on the pubic arch; this was followed by iliac osteotomy, performed using Schanz screws in the iliac wing. The osteotomized acetabulum was overturned, and inclination was reduced. | Procedure or surgery | – |
Primary outcome
Harris Hip Score
Time frame: 3 years
Higher scores, the better.
1 secondary outcome
Visual Analogue Score
Time frame: 3 years
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 17 Jan 2024.
- Background: PubMed 28641973Kocabiyik A, Misir A, Kizkapan TB, Yildiz KI, Kaygusuz MA, Alpay Y, Ezici A. Changes in Hip, Knee, and Ankle Coronal Alignments After Total Hip Arthroplasty With Transverse Femoral Shortening Osteotomy for Unilateral Crowe Type IV Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Nov;32(11):3449-3456. doi: 10.1016/j.arth.2017.05.044. Epub 2017 Jun 1.
- Background: PubMed 28043927Guo L, Yang Y, An B, Yang Y, Shi L, Han X, Gao S. Risk factors for dislocation after revision total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Feb;38:123-129. doi: 10.1016/j.ijsu.2016.12.122. Epub 2016 Dec 31.
- Background: PubMed 32943316Yetkin C, Yildirim T, Alpay Y, Tas SK, Buyukkuscu MO, Dirvar F. Evaluation of Dislocation Risk Factors With Total Hip Arthroplasty in Developmental Hip Dysplasia Patients: A Multivariate Analysis. J Arthroplasty. 2021 Feb;36(2):636-640. doi: 10.1016/j.arth.2020.08.043. Epub 2020 Aug 29.
- Background: PubMed 12377909Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92.
- Background: PubMed 27633947Sadhu A, Nam D, Coobs BR, Barrack TN, Nunley RM, Barrack RL. Acetabular Component Position and the Risk of Dislocation Following Primary and Revision Total Hip Arthroplasty: A Matched Cohort Analysis. J Arthroplasty. 2017 Mar;32(3):987-991. doi: 10.1016/j.arth.2016.08.008. Epub 2016 Aug 20.
- Background: PubMed 20512783Ballester Alfaro JJ, Sueiro Fernandez J. Trabecular Metal buttress augment and the Trabecular Metal cup-cage construct in revision hip arthroplasty for severe acetabular bone loss and pelvic discontinuity. Hip Int. 2010;20 Suppl 7:S119-27. doi: 10.1177/11207000100200s720. Epub 2010 May 27.
- Background: PubMed 12730946Dennis DA. Management of massive acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2003 Apr;18(3 Suppl 1):121-5. doi: 10.1054/arth.2003.50105.
- Background: PubMed 17403808DeBoer DK, Christie MJ, Brinson MF, Morrison JC. Revision total hip arthroplasty for pelvic discontinuity. J Bone Joint Surg Am. 2007 Apr;89(4):835-40. doi: 10.2106/JBJS.F.00313.
- Background: PubMed 23457063Sheth NP, Nelson CL, Springer BD, Fehring TK, Paprosky WG. Acetabular bone loss in revision total hip arthroplasty: evaluation and management. J Am Acad Orthop Surg. 2013 Mar;21(3):128-39. doi: 10.5435/JAAOS-21-03-128.
- Background: PubMed 8163974Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x.
- Background: PubMed 31784362Malahias MA, Ma QL, Gu A, Ward SE, Alexiades MM, Sculco PK. Outcomes of Acetabular Reconstructions for the Management of Chronic Pelvic Discontinuity: A Systematic Review. J Arthroplasty. 2020 Apr;35(4):1145-1153.e2. doi: 10.1016/j.arth.2019.10.057. Epub 2019 Nov 4.
- 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.
Mehmet Coskun, MD principal investigator
Physician
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 Congenital Hip Dysplasia and Hip Osteoarthritis, run by Van Bölge Eğitim ve Araştırma Hastanesi at 1 site in Turkey (Türkiye).
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 4 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 17 Jan 2024. 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 Turkey (Türkiye). 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?
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?
Harris Hip Score (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209255, which also lists 11 linked publications.
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 17 Jan 2024.