Arthroplasty ComplicationsNCT06320691
General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study
An observational study of Arthroplasty Complications and Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty Complications, Anesthesia
- What is being tested?
- Total Hip Arthroplasty, General Anesthesia and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 437 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2014to 25 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: - patients who underwent direct anterior approach primary total hip arhtroplasty with hip osteoarthritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively
Read the 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.
- Conditions
- Arthroplasty Complications, Anesthesia
- Being tested
- Total Hip Arthroplasty, General Anesthesia, Spinal Anesthesia
- Keywords
- total hip arthroplasty, general anesthesia, spinal anesthesia, direct anterior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Patients that underwent direct anterior approach total hip arthroplasty
General AnesthesiaProcedure or surgery
Patients that underwent general/systemic anesthesia before surgery
Spinal AnesthesiaProcedure or surgery
Patients that underwent spinal/neuraxial anesthesia before surgery
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia Group | The group that underwent direct anterior total hip arthroplasty with general-systemic anesthesia Receives: Procedure: Total Hip Arthroplasty; Procedure: General Anesthesia | |
| Spinal Anesthesia Group | The group that underwent direct anterior total hip arthroplasty with spinal-neuraxial anesthesia Receives: Procedure: Total Hip Arthroplasty; Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from preoperative session to postoperative 1 day
mean duration of surgery
Duration of total hip arthroplasty surgery for each patient
Measured: from preoperative session to postoperative 1 day
length of hospital stay
from date of operation until the date of discharge
Measured: from the date of total hip arthroplasty operation until the day that patients discharge, assesed up to 7 days
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.
Measured: postoperative 1 year
stem varus/valgus degrees
varus or valgus angulation of femoral stem after surgery
Measured: postoperative 1 year
acetabular abduction
abduction degree of acetabular component after surgery
Measured: postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start10 Jan 2014
- Primary completion10 Jan 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320691
- Sponsor's protocol ID
- BezmialemVU 1
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study
- ClinicalTrials.gov ID
- NCT06320691
- Acronym / sponsor ID
- BezmialemVU 1
- Conditions
- Arthroplasty Complications, Anesthesia
- Keywords
- total hip arthroplasty, general anesthesia, spinal anesthesia, direct anterior approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | – | Procedure: Total Hip Arthroplasty, Procedure: General AnesthesiaThe group that underwent direct anterior total hip arthroplasty with general-systemic anesthesia |
| Spinal Anesthesia Group | – | Procedure: Total Hip Arthroplasty, Procedure: Spinal AnesthesiaThe group that underwent direct anterior total hip arthroplasty with spinal-neuraxial anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- - patients who underwent direct anterior approach primary total hip arhtroplasty with hip osteoarthritis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyPatients that underwent direct anterior approach total hip arthroplasty | Procedure or surgery | General Anesthesia Group, Spinal Anesthesia Group |
| General AnesthesiaPatients that underwent general/systemic anesthesia before surgery | Procedure or surgery | General Anesthesia Group |
| Spinal AnesthesiaPatients that underwent spinal/neuraxial anesthesia before surgery | Procedure or surgery | Spinal Anesthesia Group |
Primary outcome
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)
mean duration of surgery
Time frame: from preoperative session to postoperative 1 day
Duration of total hip arthroplasty surgery for each patient
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
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.
stem varus/valgus degrees
Time frame: postoperative 1 year
varus or valgus angulation of femoral stem after surgery
acetabular abduction
Time frame: postoperative 1 year
abduction degree of acetabular component after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty Complications and Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean intraoperative estimated blood loss (time frame: from preoperative session to postoperative 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.