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

Hip Dysplasia Clinical Trial

Official title:

The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04157842
• Other study ID #: 1900025501
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: SHIGUI YAN, MD
• Phone: +86-13906531308
• Email: zrjwsj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia

Intervention

Procedure:
• total hip replacement with subtrochanteral osteotomy
applying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve
• total hip replacement with no osteotomy
just total hip replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip Harris Score	change of hip harris score scale from baseline(preoperative) to 1 year after surgery.	preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Primary	Leg Length Change	change of Leg Length from baseline(preoperative) to 1 year after surgery.	preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Primary	Radiographic Results	change of Radiographic Results from 1 week after surger to 1 year after surgery	1 week, 12 weeks, 24 weeks and 1 year after the surgery.
Primary	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.	preoperative, 1 week, 12 weeks after the surgery.
Primary	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.	preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
Primary	Blood Viscosity	change of blood viscosity from baseline(preoperative) to 1 year after surgery.	preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.