General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study

March 19, 2024 updated by: Bezmialem Vakif University
The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively

Study Overview

Detailed Description

Under general (GA) or spinal anesthesia (SA), total hip arthroplasty using the anterior approach (THA-A) can be safely performed. The best method is not sufficiently described in the literature currently in existence.This observational study was carried out at a single facility with consecutive enrollment of patients getting primary THA-A. The investigators compared the difference in complication rates, intraoperative blood loss, length of hospital stay, and duration of surgery, acetabular and femoral component orientation and stem subsidence.

Study Type

Observational

Enrollment (Actual)

437

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34140
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

- patients who underwent direct anterior approach primary total hip arhtroplasty with hip osteoarthritis

Description

Inclusion Criteria:

  • patients who underwent direct anterior approach primary total hip arthroplasty with general anesthesia
  • patients who underwent direct anterior approach primary total hip arthroplasty with spinal anesthesia

Exclusion Criteria:

  • patients who underwent revision total hip arthroplasty
  • patients who underwent total hip arthroplasty with approaches other than direct anterior approach
  • patients who underwent primary total hip arthroplasty due to hip fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General Anesthesia Group
The group that underwent direct anterior total hip arthroplasty with general-systemic anesthesia
Patients that underwent direct anterior approach total hip arthroplasty
Patients that underwent general/systemic anesthesia before surgery
Spinal Anesthesia Group
The group that underwent direct anterior total hip arthroplasty with spinal-neuraxial anesthesia
Patients that underwent direct anterior approach total hip arthroplasty
Patients that underwent spinal/neuraxial anesthesia before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean intraoperative estimated blood loss
Time Frame: from preoperative session to postoperative 1 day
Total blood volume was calculates according to Nadler's formula based on patient's sex, height and weight of the patient, whereas the estimated blood loss was calculated according to Meunier's formula (mL)
from preoperative session to postoperative 1 day
mean duration of surgery
Time Frame: from preoperative session to postoperative 1 day
Duration of total hip arthroplasty surgery for each patient
from preoperative session to postoperative 1 day
length of hospital stay
Time Frame: from the date of total hip arthroplasty operation until the day that patients discharge, assesed up to 7 days
from date of operation until the date of discharge
from the date of total hip arthroplasty operation until the day that patients discharge, assesed up to 7 days
stem subsidence
Time Frame: postoperative 1 year
Subsidence was evaluated by comparing immediate post-operative radiographic images with those obtained at 1 year follow-up. Subsidence was measured as a vertical drop of stem, characterised by a radiolucent line at the proximal most aspect of the bone-prosthesis interface.
postoperative 1 year
stem varus/valgus degrees
Time Frame: postoperative 1 year
varus or valgus angulation of femoral stem after surgery
postoperative 1 year
acetabular abduction
Time Frame: postoperative 1 year
abduction degree of acetabular component after surgery
postoperative 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2014

Primary Completion (Actual)

January 10, 2017

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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