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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06320691
Other study ID # BezmialemVU 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2014
Est. completion date May 25, 2017

Study information

Verified date March 2024
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively


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.


Recruitment information / eligibility

Status Completed
Enrollment 437
Est. completion date May 25, 2017
Est. primary completion date January 10, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total Hip Arthroplasty
Patients that underwent direct anterior approach total hip arthroplasty
General Anesthesia
Patients that underwent general/systemic anesthesia before surgery
Spinal Anesthesia
Patients that underwent spinal/neuraxial anesthesia before surgery

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean intraoperative estimated blood loss 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
Primary mean duration of surgery Duration of total hip arthroplasty surgery for each patient from preoperative session to postoperative 1 day
Primary length of hospital stay 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
Primary stem subsidence 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
Primary stem varus/valgus degrees varus or valgus angulation of femoral stem after surgery postoperative 1 year
Primary acetabular abduction abduction degree of acetabular component after surgery postoperative 1 year
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