Implant Position in Total Hip ReplacementNCT02808169
Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
An observational study of Implant Position in Total Hip Replacement, run by Barrett, William, M.D. at 1 site in United States.
Trial summary
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Position in Total Hip Replacement
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2015to 8 Aug 2016
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient under going total hip replacement
Who may be able to join
- Both: both female and male participants are being studied.
- Minimum Age: Age of participants is between 20 years - 75 years.
- Accepts: Persons who are in need of a total hip replacement
Who cannot join
- Has an existing condition that would compromise participation
- Had previous surgery on affected hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radlinik GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
Read the detailed description
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
GPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.
Measured: 4-8 weeks
Secondary outcomes (1)
Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start20 Nov 2015
- Primary completion8 Aug 2016
- Study completion8 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Position in Total Hip ReplacementStudies 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barrett, William, M.D.
- Collaborators
- DePuy Synthes
- Responsible party
- Principal investigator, William Barrett, M.D., Barrett, William, M.D.
- Investigators
- William Barrett, MD, Principal investigator, VOA Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808169
- Sponsor's protocol ID
- 20151031
- Status last verified
- Jul 2017
- First submitted
- 17 Jun 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radlinik GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
- ClinicalTrials.gov ID
- NCT02808169
- Acronym / sponsor ID
- 20151031
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Barrett, William, M.D.
- Collaborators
- DePuy Synthes
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 8 Aug 2016 (actual)
- First posted
- 21 Jun 2016 (estimated)
- 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.
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
Detailed description
Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
GPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient under going total hip replacement
Key inclusion criteria (3 listed)
- Both: both female and male participants are being studied.
- Minimum Age: Age of participants is between 20 years - 75 years.
- Accepts: Persons who are in need of a total hip replacement
Key exclusion criteria (2 listed)
- Has an existing condition that would compromise participation
- Had previous surgery on affected hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.
Time frame: 4-8 weeks
1 secondary outcome
Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.
Time frame: 4-8 weeks
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 21 Jul 2017.
Related trials for Implant Position in Total Hip Replacement
Not yet recruitingObservational study
Evaluation of a Software to Predict the Postoperative Component Position in Total Hip Arthroplasty (THA)
Total Hip Arthroplasty
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.
William Barrett, MD principal investigator
VOA Research Foundation
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 Implant Position in Total Hip Replacement, run by Barrett, William, M.D. 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 3 inclusion and 2 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 21 Jul 2017. 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?
Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films. (time frame: 4-8 weeks). 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 21 Jul 2017.