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

NCT04157842 | Unknown

• 1 other identifier: 1900025501
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hip Dysplasia

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

total hip replacement with subtrochanteral osteotomy

EXPERIMENTAL

subtrochanteral osteotomy is applied during total hip replacement

Procedure: total hip replacement with subtrochanteral osteotomy

total hip replacement with no osteotomy

SHAM COMPARATOR

no osteotomy is applied during total hip replacement.

Procedure: total hip replacement with no osteotomy

Interventions

total hip replacement with subtrochanteral osteotomy PROCEDURE

applying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve

total hip replacement with subtrochanteral osteotomy

total hip replacement with no osteotomy PROCEDURE

just total hip replacement

total hip replacement with no osteotomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Hip Dislocation

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• SHIGUI YAN, MD

  2nd affiliated hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

SHIGUI YAN, MD

CONTACT

+86-13906531308; zrjwsj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 8, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2023
• Last Updated: November 8, 2019

Record last verified: 2019-10