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Completed

NCT Number: NCT06320691

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, 34140, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

Patients that underwent direct anterior approach total hip arthroplasty

General Anesthesia

Procedure

Patients that underwent general/systemic anesthesia before surgery

Spinal anesthesia

Procedure

Patients that underwent spinal/neuraxial anesthesia before surgery

Primary outcomes

  1. 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)

  2. mean duration of surgery

    Time frame: from preoperative session to postoperative 1 day

    Duration of total hip arthroplasty surgery for each patient

  3. 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

  4. 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.

  5. stem varus/valgus degrees

    Time frame: postoperative 1 year

    varus or valgus angulation of femoral stem after surgery

  6. acetabular abduction

    Time frame: postoperative 1 year

    abduction degree of acetabular component after surgery

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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