OsteoarthritisNCT02261038
Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT
A study testing Kanekasu radiographs in people with Osteoarthritis, run by Michael Tobias Hirschmann at 1 site in Switzerland.
Trial summary
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Kanekasu radiographs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to 28 Feb 2018
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total Knee prosthesis (primary)
- >55 years
Who cannot join
- pregnancy
- lactating women
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Baselland, Bruderholz
Bruderholz, Basel-Landschaft, 4101
About this study
Official title: Comparative Study pf the Femoral Prothesis-rotation in Conventional X-Ray, in Axial CT Slices and 3D-reconstructed CT
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.
Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.
It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.
Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.
Read the detailed description
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.
Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.
It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.
In agreement with our standard diagnostic algorithm for patients with pain and problems after TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is comparable reliable, it could be possible to use this radiograph instead.
Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees. The measurements are performed with two weeks interval and the different observers are blinded to their previous and the measurements of the others.
The absolute difference of femoral TKA rotation is calculated between and inter the groups investigated.
Intra class correlation coefficients are calculated for inter- and intraobserver reliability.
- Conditions
- Osteoarthritis
- Being tested
- Kanekasu radiographs
- Keywords
- total knee arthroplasty, total knee prothesis, X-Ray, Kanekasu radiographs, femoral component rotation, effects
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kanekasu radiographsOther
Also called Femoral component rotation, total knee prothesis, X-ray, kanekasu-technic
No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.
| Study group | Role | What they receive |
|---|---|---|
| Kanekasu radiographs | Other | No drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique). Receives: Other: Kanekasu radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral TKA component rotation in degrees
Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.
Measured: one year
Secondary outcomes (1)
Inter- and intraobserver reliability of TKA femoral component rotation
Inter- and intraobserver reliability of TKA femoral component rotation are calculated by intra class correlation coefficients (ICC) and compared between all three measurement methods.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startNov 2014
- Primary completion1 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Tobias Hirschmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Tobias Hirschmann, Kantonsspital Baselland Bruderholz
- Investigators
- Michael T. Hirschmann, MD, Principal investigator, Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261038
- Sponsor's protocol ID
- Rad-2CT-3CT_001_MH
- Other IDs
- 332/13
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2014
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study pf the Femoral Prothesis-rotation in Conventional X-Ray, in Axial CT Slices and 3D-reconstructed CT
- ClinicalTrials.gov ID
- NCT02261038
- Acronym / sponsor ID
- Rad-2CT-3CT_001_MH
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty, total knee prothesis, X-Ray, Kanekasu radiographs, femoral component rotation, effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Michael Tobias HirschmannUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 10 Oct 2014 (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.
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.
Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.
It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.
Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees.
Detailed description
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important factor for outcome. However, measurement of femoral component rotation is difficult to perform.
Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique), axial CT slices and 3D reconstructed CT images.
It was the hypothesis that measurements on radiographs are comparable to measurement on CT images.
In agreement with our standard diagnostic algorithm for patients with pain and problems after TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is comparable reliable, it could be possible to use this radiograph instead.
Measurements of femoral TKA rotation will be measured three times by three different observers and inter- and intraobserver reliability is calculated. The absolute values of each measurement method is noted in degrees. The measurements are performed with two weeks interval and the different observers are blinded to their previous and the measurements of the others.
The absolute difference of femoral TKA rotation is calculated between and inter the groups investigated.
Intra class correlation coefficients are calculated for inter- and intraobserver reliability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kanekasu radiographs | Other | Other: Kanekasu radiographsNo drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique). |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Total Knee prosthesis (primary)
- >55 years
Key exclusion criteria (2 listed)
- pregnancy
- lactating women
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 |
|---|---|---|
| Kanekasu radiographsAlso: Femoral component rotation, total knee prothesis, X-ray, kanekasu-technicNo interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation. | Other | Kanekasu radiographs |
Primary outcome
Femoral TKA component rotation in degrees
Time frame: one year
Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.
1 secondary outcome
Inter- and intraobserver reliability of TKA femoral component rotation
Time frame: one year
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 24 Oct 2018.
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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.
Michael T. Hirschmann, MD principal investigator
Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kanekasu radiographs in people with Osteoarthritis, run by Michael Tobias Hirschmann at 1 site in Switzerland.
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 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 24 Oct 2018. 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 Switzerland. 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?
Femoral TKA component rotation in degrees (time frame: one year). 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 24 Oct 2018.