Hip OsteoarthritisNCT05871827
THA With and Without Computer Navigation
An observational study of Hip Osteoarthritis and Avascular Necrosis of Hip, run by Southeast Orthopedic Specialists at 1 site in United States.
Trial summary
The goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (THA) with and without the use of a computer navigation program. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hip Osteoarthritis, Avascular Necrosis of Hip
- What is being tested?
- Intraoperative Fluoroscopic Computer Navigation
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to 5 Jan 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent DA THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup.
Who may be able to join
- Patients who underwent Direct Anterior (DA) THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup with or without computer navigation
Who cannot join
- Patients who underwent subsequent revision THA, conversion arthroplasty, hybrid procedures, experienced native or postoperative dislocations, and missing or inadequate radiographs at time of data collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast Orthopedic Specialists
Jacksonville, Florida, 32216
About this study
Official title: The Use of Intraoperative Fluoroscopic Computer Navigation on Hip Arthroplasty Component Position
The goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (THA) with and without the use of a computer navigation program. The main questions this study aims to answer are:
- Can using computer navigation produce better THA implant placement?
- Can using computer navigation make surgery more efficient?
Participant data collected include their postoperative x-rays and total operative time.
Read the detailed description
The goal of this retrospective study is to compare implant placement and operative time of patients who underwent direct anterior total hip arthroplasty with and without the use of a computer navigation program. X-rays are used to measure acetabular cup orientation, leg length discrepancy, and total operative time.
- Conditions
- Hip Osteoarthritis, Avascular Necrosis of Hip
- Being tested
- Intraoperative Fluoroscopic Computer Navigation
- Keywords
- total hip arthroplasty, computer navigation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Fluoroscopic Computer NavigationProcedure or surgery
Computer technology used during surgery
| Study group | Role | What they receive |
|---|---|---|
| Traditional Overlay | Subjects who underwent THA without use of computer navigation | |
| Computer Navigation | Subjects who underwent THA with use of computer navigation Receives: Procedure: Intraoperative Fluoroscopic Computer Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cup inclination
Acetabular cup orientation
Measured: 12 weeks post op
Cup anteversion
Acetabular cup anteversion
Measured: 12 weeks post op
Leg length discrepancy
Leg length discrepancy
Measured: 12 weeks post op
Operative time
Operative time in minutes
Measured: Immediate post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start25 Feb 2020
- Primary completion3 Oct 2022
- Study completion5 Jan 2023
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
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast Orthopedic Specialists
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- John Redmond, MD, Principal investigator, Southeast Orthopedic Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871827
- Sponsor's protocol ID
- DPS-JMP-2019-078
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intraoperative Fluoroscopic Computer Navigation on Hip Arthroplasty Component Position
- ClinicalTrials.gov ID
- NCT05871827
- Acronym / sponsor ID
- DPS-JMP-2019-078
- Conditions
- Hip Osteoarthritis, Avascular Necrosis of Hip
- Keywords
- total hip arthroplasty, computer navigation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Southeast Orthopedic SpecialistsResearch network
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 23 May 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.
The goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (THA) with and without the use of a computer navigation program. The main questions this study aims to answer are:
- Can using computer navigation produce better THA implant placement?
- Can using computer navigation make surgery more efficient?
Participant data collected include their postoperative x-rays and total operative time.
Detailed description
The goal of this retrospective study is to compare implant placement and operative time of patients who underwent direct anterior total hip arthroplasty with and without the use of a computer navigation program. X-rays are used to measure acetabular cup orientation, leg length discrepancy, and total operative time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Overlay | – | –Subjects who underwent THA without use of computer navigation |
| Computer Navigation | – | Procedure: Intraoperative Fluoroscopic Computer NavigationSubjects who underwent THA with use of computer navigation |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent DA THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup.
Key inclusion criteria (1 listed)
- Patients who underwent Direct Anterior (DA) THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup with or without computer navigation
Key exclusion criteria (1 listed)
- Patients who underwent subsequent revision THA, conversion arthroplasty, hybrid procedures, experienced native or postoperative dislocations, and missing or inadequate radiographs at time of data collection.
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 |
|---|---|---|
| Intraoperative Fluoroscopic Computer NavigationComputer technology used during surgery | Procedure or surgery | Computer Navigation |
Primary outcome
Cup inclination
Time frame: 12 weeks post op
Acetabular cup orientation
Cup anteversion
Time frame: 12 weeks post op
Acetabular cup anteversion
Leg length discrepancy
Time frame: 12 weeks post op
Leg length discrepancy
Operative time
Time frame: Immediate post op
Operative time in minutes
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 23 May 2023.
- Individual participant dataSharing planned: No
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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.
John Redmond, MD principal investigator
Southeast Orthopedic Specialists
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 Hip Osteoarthritis and Avascular Necrosis of Hip, run by Southeast Orthopedic Specialists at 1 site in United States.
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 1 inclusion and 1 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 23 May 2023. 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 United States. 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?
Cup inclination (time frame: 12 weeks post op). The study lists 4 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 23 May 2023.