Total Hip ReplacementNCT02536573
Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software
A study testing Radlink Surgical Positioning Software in people with Total Hip Replacement, run by Anderson Orthopaedic Research Institute.
Trial summary
This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Radlink Surgical Positioning Software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Apr 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip arthroplasty
Who cannot join
- -
About this study
Official title: Prospective, Randomized Study to Evaluate Total Hip Arthroplasty With and Without Radlink Surgical Positioning Software
This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.
- Conditions
- Total Hip Replacement
- Being tested
- Radlink Surgical Positioning Software
- Keywords
- Total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radlink Surgical Positioning SoftwareOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Intraoperative fluoroscopy of the hip is used to visually estimate the acetabular cup angle and make any necessary adjustments. |
| Radlink Surgical Positioning System | Experimental | Fluoroscopic image of the hip joint is imported into the Radlink Surgical Positioning software. The software calculates a target cup position using bony landmarks, and the surgeon matches the cup to the target. Receives: Other: Radlink Surgical Positioning Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic cup abduction angle
Angle of acetabular component in coronal plane measured on x-ray
Measured: 4 month postoperative
Radiographic cup anteversion angle
Angle of acetabular component in sagittal plane measured on x-ray
Measured: 4 month postoperative
Secondary outcomes (1)
Variance of cup angles measured on x-ray
Statistical homogeneity of angles and how spread out the data is.
Measured: 4 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startDec 2015
- Primary completion11 Apr 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William G Hamilton, MD, Principal investigator, AORI (Anderson Orthopaedic Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536573
- Sponsor's protocol ID
- AORI 2015-0101
- Status last verified
- Jul 2019
- First submitted
- 24 Aug 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study to Evaluate Total Hip Arthroplasty With and Without Radlink Surgical Positioning Software
- ClinicalTrials.gov ID
- NCT02536573
- Acronym / sponsor ID
- AORI 2015-0101
- Conditions
- Total Hip Replacement
- Keywords
- Total hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 1 Sep 2015 (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.
This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Intraoperative fluoroscopy of the hip is used to visually estimate the acetabular cup angle and make any necessary adjustments. |
| Radlink Surgical Positioning System | Experimental | Other: Radlink Surgical Positioning SoftwareFluoroscopic image of the hip joint is imported into the Radlink Surgical Positioning software. The software calculates a target cup position using bony landmarks, and the surgeon matches the cup to the target. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total hip arthroplasty
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Radlink Surgical Positioning Software | Other | Radlink Surgical Positioning System |
Primary outcome
Radiographic cup abduction angle
Time frame: 4 month postoperative
Angle of acetabular component in coronal plane measured on x-ray
Radiographic cup anteversion angle
Time frame: 4 month postoperative
Angle of acetabular component in sagittal plane measured on x-ray
1 secondary outcome
Variance of cup angles measured on x-ray
Time frame: 4 month postoperative
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 1 Aug 2019.
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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.
William G Hamilton, MD principal investigator
AORI (Anderson Orthopaedic Research Institute)
Questions about this trial
What is this clinical trial studying?
A study testing Radlink Surgical Positioning Software in people with Total Hip Replacement, run by Anderson Orthopaedic Research Institute.
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 1 Aug 2019. 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?
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?
Radiographic cup abduction angle (time frame: 4 month postoperative). The study lists 2 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 1 Aug 2019.