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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Dysplasia
• Intervention / Treatment: Procedure: total hip replacement with subtrochanteral osteotomy; Procedure: total hip replacement with no osteotomy

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SHIGUI YAN, MD; Phone Number: +86-13906531308; Email: zrjwsj@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: SHIGUI YAN, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 1900025501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No