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Trial record 3 of 630 for:    "Hip replacement"

The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient

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ClinicalTrials.gov Identifier: NCT04157842
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.

Condition or disease Intervention/treatment Phase
Hip Dysplasia Procedure: total hip replacement with subtrochanteral osteotomy Procedure: total hip replacement with no osteotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: total hip replacement with subtrochanteral osteotomy
subtrochanteral osteotomy is applied during total hip replacement
Procedure: total hip replacement with subtrochanteral osteotomy
applying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve

Sham Comparator: total hip replacement with no osteotomy
no osteotomy is applied during total hip replacement.
Procedure: total hip replacement with no osteotomy
just total hip replacement




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unilateral Crow IV hip dysplasia;
  • Bilateral Crow IV hip dysplasia without osteoarthritis on the other side

Exclusion Criteria:

  • Patients with serious medical disease;
  • Patients with lower extremity vascular disease; 3. Patients with severe mental illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157842


Contacts
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Contact: SHIGUI YAN, MD +86-13906531308 zrjwsj@zju.edu.cn

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: SHIGUI YAN, MD 2nd affiliated hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04157842     History of Changes
Other Study ID Numbers: 1900025501
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities