NCT03973320

Brief Summary

This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 5, 2024

Completed
Last Updated

December 27, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

May 28, 2019

Results QC Date

May 5, 2022

Last Update Submit

December 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality

    The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.

    Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery

Study Arms (1)

Primary Total Hip Arthroplasty

This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty

Other: Chart Review

Interventions

This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.

Primary Total Hip Arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing Primary Total Hip Arthroplasty

You may qualify if:

  • All primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs

You may not qualify if:

  • Revision primary total hip arthroplasty
  • Incomplete intraoperative vital signs
  • Anterior total hip arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Jiabin Liu
Organization
Hospital for Special Surgery, Anesthesiology

Study Officials

  • Jiabin Liu, MD, PhD

    Hospital for Special Surgey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 4, 2019

Study Start

December 27, 2018

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

December 27, 2024

Results First Posted

April 5, 2024

Record last verified: 2024-03

Locations