The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic HipsNCT04834492
The Results of Total Hip Arthroplasty in Crowe Type 4 Hips.
An observational study of The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic Hips, run by Private Ortopedia Hospital, Seyhan Adana at 1 site in Turkey (Türkiye).
Trial summary
Total hip arthroplasty (THA) performed for developmental dysplasia of the hip (DDH) is a technically difficult procedure with a high complication rate, especially in the presence of completely dislocated hips. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic Hips
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 30 Mar 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Crowe type 4 developmental dysplasia of the hip patient
Who may be able to join
- Crowe type 4 developmental dysplasia of the hip
Who cannot join
- Primary Coxarthrosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Ortopedia Hospital
Adana, Adana, 01130
About this study
Official title: At Least 10-Year Results of Cementless Ceramic-On-Ceramic Total Hip Arthroplasty Performed With Transverse Subtrochanteric Osteotomy in Crowe Type 4 Hips.
Total hip arthroplasty (THA) performed for developmental dysplasia of the hip (DDH) is a technically difficult procedure with a high complication rate, especially in the presence of completely dislocated hips. This study aimed to evaluate the results of at least 10 years of follow-up results of cementless, ceramic-on-ceramic (CoC) total hip arthroplasty performed with transverse subtrochanteric osteotomy in Crowe type 4 hips.
Read the detailed description
We reviewed retrospectively 67 hips of 50 patients which underwent CoC, cementless THA with transverse subtrochanteric osteotomy between 2008 and 2011. Clinical and radiological data of the hips were examined. Clinical results were evaluated using the Harris Hip Score (HHS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- Being tested
- Total hip arthroplasty
- Keywords
- Developmental dysplasia of the hip, total hip arthroplasty, transverse subtrochanteric shortening osteotomy, ceramic on ceramic, cementless.
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyProcedure or surgery
Total hip arthroplasty in Crowe type 4 developmental dysplasia of the hip.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical results
Haris Hip Score
Measured: minimum 10 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Jul 2020
- Primary completion10 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic HipsStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Private Ortopedia Hospital, Seyhan Adana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagri Ors, Private Ortopedia Hospital, Seyhan Adana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834492
- Sponsor's protocol ID
- Crowe type 4
- Status last verified
- Apr 2021
- First submitted
- 4 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At Least 10-Year Results of Cementless Ceramic-On-Ceramic Total Hip Arthroplasty Performed With Transverse Subtrochanteric Osteotomy in Crowe Type 4 Hips.
- ClinicalTrials.gov ID
- NCT04834492
- Acronym / sponsor ID
- Crowe type 4
- Keywords
- Developmental dysplasia of the hip, total hip arthroplasty, transverse subtrochanteric shortening osteotomy, ceramic on ceramic, cementless.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Private Ortopedia Hospital, Seyhan AdanaUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Apr 2021 (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.
Total hip arthroplasty (THA) performed for developmental dysplasia of the hip (DDH) is a technically difficult procedure with a high complication rate, especially in the presence of completely dislocated hips. This study aimed to evaluate the results of at least 10 years of follow-up results of cementless, ceramic-on-ceramic (CoC) total hip arthroplasty performed with transverse subtrochanteric osteotomy in Crowe type 4 hips.
Detailed description
We reviewed retrospectively 67 hips of 50 patients which underwent CoC, cementless THA with transverse subtrochanteric osteotomy between 2008 and 2011. Clinical and radiological data of the hips were examined. Clinical results were evaluated using the Harris Hip Score (HHS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Crowe type 4 developmental dysplasia of the hip patient
Key inclusion criteria (1 listed)
- Crowe type 4 developmental dysplasia of the hip
Key exclusion criteria (1 listed)
- Primary Coxarthrosis
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 |
|---|---|---|
| Total hip arthroplastyTotal hip arthroplasty in Crowe type 4 developmental dysplasia of the hip. | Procedure or surgery | – |
Primary outcome
Clinical results
Time frame: minimum 10 year follow-up
Haris Hip Score
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 8 Apr 2021.
- Individual participant dataSharing planned: No
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.
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 The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic Hips, run by Private Ortopedia Hospital, Seyhan Adana 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 1 inclusion and 1 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 8 Apr 2021. 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?
Clinical results (time frame: minimum 10 year follow-up). 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 8 Apr 2021.