Hip ArthropathyNCT05149729
Mid-Term Natural Course Postoperative of Crowe Type III-IV Hip Dysplasia
A study testing Shortened hip arthroplasty in people with Hip Arthropathy and Hip Dysplasia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of preoperative and postoperative mid-term course of patients with Crowe Type 3 and Type 4 hip dysplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthropathy, Hip Dysplasia
- What is being tested?
- Shortened hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 10 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crowe type 3 and 4 patients over 18 years of age who had shortened hip replacement surgery
Who cannot join
- Crowe type 1 or 2 patients over 18 years of age who had shortened hip replacement surgery
- Patients who have previously operated on the contralateral hip
- Patients who underwent shortened hip replacement for a reason other than developmental dysplasia of the hip
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University
Istanbul, Fatih, 34500
Hakan Batuhan Kaya, 00905542294339, hbatuhan-kaya-123@hotmail.com
Hakan Batuhan Kaya
About this study
Official title: Mid-Term Natural Course of Lower Extremity and Spine After Total Hip Arthroplasty in Patients With Crowe Type III-IV Hip Dysplasia
Comparison of preoperative and postoperative mid-term course of patients with Crowe Type 3 and Type 4 hip dysplasia.
Read the detailed description
Crowe type 3 and type 4 patients who underwent shortened hip replacement surgery will be followed up for 2 years.
Patients will be called for routine outpatient controls at the 2nd week, 6th week, 3rd month, 6th month, 12th month, 24th month.
Patients will be referred to the physical therapy specialist for abduction strengthening and pelvis tilt corrective exercises starting from the 6th week.
Scoliosis and orthoroentgenography x-rays will be taken at the last control of the patients.
HHS, WOMAC hip score and SF-12 score will be obtained from the patients. Scores, lower extremity and spine angles will be evaluated after the last examinations performed at 12 and 24 months.
- Conditions
- Hip Arthropathy, Hip Dysplasia
- Being tested
- Shortened hip arthroplasty
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortened hip arthroplastyProcedure or surgery
Crowe type 3 and 4 patients who underwent shortened hip prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Crowe type 3 and 4 patients undergoing shortened hip replacement | Experimental | Clinical and radiological results of Crowe type 3 and 4 patients who underwent shortened hip prosthesis at 12 and 24 months Receives: Procedure: Shortened hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC score range, which indicates the clinical satisfaction of the patients, is between 0-100.
Measured: The degree of improvement in Vomac score will be evaluated by looking at preoperative and postoperative 12th month Vomac scores.( 0-12th month )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start10 Feb 2021
- Primary completion10 May 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients over the age of 18 who underwent Crowe Type 3 and Type 4 shortened hip prosthesis
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Sarikas, Bezmialem Vakif University
- Investigators
- Gökçer Uzer, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149729
- Sponsor's protocol ID
- E.16313
- Status last verified
- Dec 2021
- First submitted
- 8 Oct 2021
- Last updated
- 8 Dec 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 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-Term Natural Course of Lower Extremity and Spine After Total Hip Arthroplasty in Patients With Crowe Type III-IV Hip Dysplasia
- ClinicalTrials.gov ID
- NCT05149729
- Acronym / sponsor ID
- E.16313
- Conditions
- Hip Arthropathy, Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 8 Dec 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.
Comparison of preoperative and postoperative mid-term course of patients with Crowe Type 3 and Type 4 hip dysplasia.
Detailed description
Crowe type 3 and type 4 patients who underwent shortened hip replacement surgery will be followed up for 2 years.
Patients will be called for routine outpatient controls at the 2nd week, 6th week, 3rd month, 6th month, 12th month, 24th month.
Patients will be referred to the physical therapy specialist for abduction strengthening and pelvis tilt corrective exercises starting from the 6th week.
Scoliosis and orthoroentgenography x-rays will be taken at the last control of the patients.
HHS, WOMAC hip score and SF-12 score will be obtained from the patients. Scores, lower extremity and spine angles will be evaluated after the last examinations performed at 12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients over the age of 18 who underwent Crowe Type 3 and Type 4 shortened hip prosthesis
| Arm | Type | Receives |
|---|---|---|
| Crowe type 3 and 4 patients undergoing shortened hip replacement | Experimental | Procedure: Shortened hip arthroplastyClinical and radiological results of Crowe type 3 and 4 patients who underwent shortened hip prosthesis at 12 and 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Crowe type 3 and 4 patients over 18 years of age who had shortened hip replacement surgery
Key exclusion criteria (3 listed)
- Crowe type 1 or 2 patients over 18 years of age who had shortened hip replacement surgery
- Patients who have previously operated on the contralateral hip
- Patients who underwent shortened hip replacement for a reason other than developmental dysplasia of the hip
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 |
|---|---|---|
| Shortened hip arthroplastyCrowe type 3 and 4 patients who underwent shortened hip prosthesis | Procedure or surgery | Crowe type 3 and 4 patients undergoing shortened hip replacement |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: The degree of improvement in Vomac score will be evaluated by looking at preoperative and postoperative 12th month Vomac scores.( 0-12th month )
The WOMAC score range, which indicates the clinical satisfaction of the patients, is between 0-100.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- EFFECTS OF TOTAL HIP ARTHROPLASTY ON AXIAL ALIGNMENTLink provided by the sponsor.
- 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 HIPLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hip Arthropathy
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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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.
Gökçer Uzer study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shortened hip arthroplasty in people with Hip Arthropathy and Hip Dysplasia, run by Bezmialem Vakif University 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 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 8 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hakan batuhan kaya (00905542294339, hbatuhan-kaya-123@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: The degree of improvement in Vomac score will be evaluated by looking at preoperative and postoperative 12th month Vomac scores.( 0-12th month )). 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 Dec 2021.