- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320691
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BezmialemVU 1
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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