Hip OsteoarthritisNCT05794282
Robotic Total Hip Arthroplasty Anesthesia Management
An observational study of Hip Osteoarthritis and Joint Diseases, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
Robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology. The investigators aimed to share their anesthesia management experience as well as compare robotic unilateral total hip arthroplasty with conventional surgical technique in this… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hip Osteoarthritis, Joint Diseases, Anesthesia
- What is being tested?
- the robot assisted total hip arthroplasty and the conventional total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 15 May 2023
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with American Society of Anesthesiologists (ASA) physical status I-III and elective unilateral THAs between the ages of 40 and 85 will be analyzed.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Between 40-85 years
- Elective unilateral THAs which were performed by a single senior orthopedic surgeon
- Between January 2021 and January 2023 under CSEA.
Who cannot join
- Urgent surgery
- Bilateral surgery
- Previous surgery
- Missing data and lost to follow-up in the perioperative period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Robotic Total Hip Arthroplasty Anesthesia Management: Retrospective Study
Robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology. The investigators aimed to share their anesthesia management experience as well as compare robotic unilateral total hip arthroplasty with conventional surgical technique in this retrospective study.
Read the detailed description
This study was conducted after obtaining ethics committee approval.
The inclusion criteria were as follows: American Society of Anesthesiologists (ASA) physical status I-III patients between 40-85 years, elective unilateral THAs which were performed by a single senior orthopedic surgeon and orthopedic team between January 2021 and January 2023 under CSEA. Exclusion criteria were urgent surgery, bilateral surgery, previous surgery, missing data, and lost to follow-up in the perioperative period.
The routine anesthetic protocol for the TKA was as follows: A single dose of 0.5% hyperbaric bupivacaine between 15-10 mg was administered intratechally. Following this the epidural catheter was inserted 4 cm into the epidural space through the epidural needle and secured. The level of the sensory block was assessed using pin-prick and cold sensation tests, and motor block using the Bromage scale. The patients were followed in the postanesthesia care unit (PACU) after the surgery. Patients with a modified Aldrete scoring system ≥9 were considered to be eligible for the transfer from PACU to the service.
Pain was evaluated using a Visual Analogue Scale (VAS) with regular intervals. Data were collected from hospital's electronic database records, patient files, and anesthesia charts.
- Conditions
- Hip Osteoarthritis, Joint Diseases, Anesthesia
- Being tested
- the robot assisted total hip arthroplasty, the conventional total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the robot assisted total hip arthroplastyProcedure or surgery
the robot assisted total hip arthroplasty
the conventional total hip arthroplastyProcedure or surgery
the conventional total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Group rTHA (robotic total hip arthroplasty) | the robot assisted total hip arthroplasty Receives: Procedure: the robot assisted total hip arthroplasty | |
| Group cTHA (conventional total hip arthroplasty) | the conventional total hip arthroplasty Receives: Procedure: the conventional total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
The duration of surgical procedures
Measured: Only in surgery time, an average of 3 hours]
Secondary outcomes (2)
Complications
Perioperative complications rates
Measured: After the end of surgery, in the first 1-month follow-up
Hospital discharge time
Time from the beginning of the operation to the discharge of hospital
Measured: Time from discharge from PACU to discharge from hospital, an average of 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Kara, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794282
- Sponsor's protocol ID
- 2023-65
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Total Hip Arthroplasty Anesthesia Management: Retrospective Study
- ClinicalTrials.gov ID
- NCT05794282
- Acronym / sponsor ID
- 2023-65
- Conditions
- Hip Osteoarthritis, Joint Diseases, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 3 Apr 2023 (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.
Robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology. The investigators aimed to share their anesthesia management experience as well as compare robotic unilateral total hip arthroplasty with conventional surgical technique in this retrospective study.
Detailed description
This study was conducted after obtaining ethics committee approval.
The inclusion criteria were as follows: American Society of Anesthesiologists (ASA) physical status I-III patients between 40-85 years, elective unilateral THAs which were performed by a single senior orthopedic surgeon and orthopedic team between January 2021 and January 2023 under CSEA. Exclusion criteria were urgent surgery, bilateral surgery, previous surgery, missing data, and lost to follow-up in the perioperative period.
The routine anesthetic protocol for the TKA was as follows: A single dose of 0.5% hyperbaric bupivacaine between 15-10 mg was administered intratechally. Following this the epidural catheter was inserted 4 cm into the epidural space through the epidural needle and secured. The level of the sensory block was assessed using pin-prick and cold sensation tests, and motor block using the Bromage scale. The patients were followed in the postanesthesia care unit (PACU) after the surgery. Patients with a modified Aldrete scoring system ≥9 were considered to be eligible for the transfer from PACU to the service.
Pain was evaluated using a Visual Analogue Scale (VAS) with regular intervals. Data were collected from hospital's electronic database records, patient files, and anesthesia charts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group rTHA (robotic total hip arthroplasty) | – | Procedure: the robot assisted total hip arthroplastythe robot assisted total hip arthroplasty |
| Group cTHA (conventional total hip arthroplasty) | – | Procedure: the conventional total hip arthroplastythe conventional total hip arthroplasty |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with American Society of Anesthesiologists (ASA) physical status I-III and elective unilateral THAs between the ages of 40 and 85 will be analyzed.
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Between 40-85 years
- Elective unilateral THAs which were performed by a single senior orthopedic surgeon
- Between January 2021 and January 2023 under CSEA.
Key exclusion criteria (4 listed)
- Urgent surgery
- Bilateral surgery
- Previous surgery
- Missing data and lost to follow-up in the perioperative period
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 |
|---|---|---|
| the robot assisted total hip arthroplastythe robot assisted total hip arthroplasty | Procedure or surgery | Group rTHA (robotic total hip arthroplasty) |
| the conventional total hip arthroplastythe conventional total hip arthroplasty | Procedure or surgery | Group cTHA (conventional total hip arthroplasty) |
Primary outcome
Time
Time frame: Only in surgery time, an average of 3 hours]
The duration of surgical procedures
2 secondary outcomes
Complications
Time frame: After the end of surgery, in the first 1-month follow-up
Hospital discharge time
Time frame: Time from discharge from PACU to discharge from hospital, an average of 96 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Joint Diseases, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umut Kara (+905339392399, drumutkara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: Only in surgery time, an average of 3 hours]). 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 5 Apr 2023.