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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04157842
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 48

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hip Harris Score [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Chair: SHIGUI YAN, MD, 2nd affiliated hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04157842
• Other Study ID Numbers: 1900025501
• First Posted: Nov 8, 2019
• Last Update Posted: Nov 8, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital

Study Results

No Results Posted as of Nov 8, 2019