Hip DysplasiaNCT04157842
The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
A study testing total hip replacement with subtrochanteral osteotomy and total hip replacement with no osteotomy in people with Hip Dysplasia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- total hip replacement with subtrochanteral osteotomy and total hip replacement with no osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Nov 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral Crow IV hip dysplasia;
- Bilateral Crow IV hip dysplasia without osteoarthritis on the other side
Who cannot join
- Patients with serious medical disease;
- Patients with lower extremity vascular disease; 3. Patients with severe mental illness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.
Read the detailed description
Changes of limb length after total hip replacement is common, especially for Crowe Ⅳ hip dysplasia patient. Such change potentially increases tension of vessel and influence lower extremity hemodynamics. Till now, little is known in this area.
- Conditions
- Hip Dysplasia
- Being tested
- total hip replacement with subtrochanteral osteotomy, total hip replacement with no osteotomy
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip replacement with subtrochanteral osteotomyProcedure or surgery
applying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve
total hip replacement with no osteotomyProcedure or surgery
just total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| total hip replacement with subtrochanteral osteotomy | Experimental | subtrochanteral osteotomy is applied during total hip replacement Receives: Procedure: total hip replacement with subtrochanteral osteotomy |
| total hip replacement with no osteotomy | Sham comparator | no osteotomy is applied during total hip replacement. Receives: Procedure: total hip replacement with no osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Harris Score
change of hip harris score scale from baseline(preoperative) to 1 year after surgery.
Measured: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Leg Length Change
change of Leg Length from baseline(preoperative) to 1 year after surgery.
Measured: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Radiographic Results
change of Radiographic Results from 1 week after surger to 1 year after surgery
Measured: 1 week, 12 weeks, 24 weeks and 1 year after the surgery.
Lower Limb Arterial CT Angiography
change of vascular diameter and vascular cross-sectional from baseline(preoperative) to 1 year after surgery baseline(preoperative) to 12 weeks after surgery.
Measured: preoperative, 1 week, 12 weeks after the surgery.
Vascular Ultrasound Examination
change of systolic peak velocity, end-diastolic velocity, pulsation index, resistance index and blood flow from baseline(preoperative) to 1 year after surgery.
Measured: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Blood Viscosity
change of blood viscosity from baseline(preoperative) to 1 year after surgery.
Measured: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHIGUI YAN, MD, Study chair, 2nd affiliated hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157842
- Sponsor's protocol ID
- 1900025501
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
- ClinicalTrials.gov ID
- NCT04157842
- Acronym / sponsor ID
- 1900025501
- Conditions
- Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 Nov 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.
Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.
Detailed description
Changes of limb length after total hip replacement is common, especially for Crowe Ⅳ hip dysplasia patient. Such change potentially increases tension of vessel and influence lower extremity hemodynamics. Till now, little is known in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total hip replacement with subtrochanteral osteotomy | Experimental | Procedure: total hip replacement with subtrochanteral osteotomysubtrochanteral osteotomy is applied during total hip replacement |
| total hip replacement with no osteotomy | Sham comparator | Procedure: total hip replacement with no osteotomyno osteotomy is applied during total hip replacement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral Crow IV hip dysplasia;
- Bilateral Crow IV hip dysplasia without osteoarthritis on the other side
Key exclusion criteria (2 listed)
- Patients with serious medical disease;
- Patients with lower extremity vascular disease; 3. Patients with severe mental illness.
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 replacement with subtrochanteral osteotomyapplying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve | Procedure or surgery | total hip replacement with subtrochanteral osteotomy |
| total hip replacement with no osteotomyjust total hip replacement | Procedure or surgery | total hip replacement with no osteotomy |
Primary outcome
Hip Harris Score
Time frame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
change of hip harris score scale from baseline(preoperative) to 1 year after surgery.
Leg Length Change
Time frame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
change of Leg Length from baseline(preoperative) to 1 year after surgery.
Radiographic Results
Time frame: 1 week, 12 weeks, 24 weeks and 1 year after the surgery.
change of Radiographic Results from 1 week after surger to 1 year after surgery
Lower Limb Arterial CT Angiography
Time frame: preoperative, 1 week, 12 weeks after the surgery.
change of vascular diameter and vascular cross-sectional from baseline(preoperative) to 1 year after surgery baseline(preoperative) to 12 weeks after surgery.
Vascular Ultrasound Examination
Time frame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
change of systolic peak velocity, end-diastolic velocity, pulsation index, resistance index and blood flow from baseline(preoperative) to 1 year after surgery.
Blood Viscosity
Time frame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
change of blood viscosity from baseline(preoperative) to 1 year after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
SHIGUI YAN, MD study chair
2nd affiliated hospital, School of Medicine, Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing total hip replacement with subtrochanteral osteotomy and total hip replacement with no osteotomy in people with Hip Dysplasia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 2 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 Nov 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. Some participants in this study may receive a placebo. 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 SHIGUI YAN, MD (+86-13906531308, zrjwsj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Harris Score (time frame: preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.). The study lists 6 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 8 Nov 2019.