Musculoskeletal DiseasesNCT05432609
Standardization and Reproducibility Regarding Scanning Procedures and Measurements of Weight-bearing Cone Beam CT in the Lower Extremity
An observational study of Musculoskeletal Diseases, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Cone Beam CT (CBCT) of the knee is gaining interest, especially regarding patients suffering from patellofemoral instability. With this study investigators wish to investigate the day-to-day, test-retest reliability of weight bearing (WB) and non-weight bearing (NWB) CBCT of the knee in healthy participants and… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Weight bearing CT
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 15 Sep 2025
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants recruited amongst employees in the ER, Bispebjerg-Frederiksberg Hospital Trochlear dysplasia patients selected from the sports surgery unit, Bispebjerg-Frederiksberg Hospital
Who may be able to join
- Substudy 1:Healthy
- Male or female aged 18-39 years
- Must be able to stand on one leg for 30 seconds
- Substudy 2
- Diagnosed with trochlear dysplasia, in addition healthy
- Male or female aged 18-39 years
- Patients scheduled to either a trochlear plastic surgery + MPFL reconstruction or Elmslie- Trillat + MPFL reconstruction + trochlear plastic surgery
- Must be able to stand on one leg for 30 seconds
Who cannot join
- Substudy 1
- Current knee injury and / or knee pain.
- Known rheumatoid and / or connective tissue disease.
- Previous treatment requiring knee injury and / or knee surgery.
- Pregnancy
- Substudy 2
Show all 10Show fewer
- Known rheumatoid and / or connective tissue disease
- Previous treatment requiring knee injury and / or knee surgery.
- Patients who need distalization
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Radiology, Bispebjerg-Frederiksberg Hospital
Copenhagen, 2000
About this study
Cone Beam CT (CBCT) of the knee is gaining interest, especially regarding patients suffering from patellofemoral instability. With this study investigators wish to investigate the day-to-day, test-retest reliability of weight bearing (WB) and non-weight bearing (NWB) CBCT of the knee in healthy participants and patients suffering from trochlear dysplasia. The participants and patients will be scanned in the following positions: 0° WB, 0° NWB, 20° WB, 20° NWB on two separate days. The trochlear dysplasia patients will furthermore be scanned 6 months postoperatively.
The aim is to develop af protocol on how to both position patients during weight bearing scannings as well as a protocol on how to prepare the cross sectional images before measurements.
Read the detailed description
Investigators expect that scans performed with CBCT will show a clear change in the TT-TG distance when comparing scans performed in two different degrees of flexion of the knee. Investigators expect a discrete change in the TT-TG distance between non-weight bearing and weight-bearing state of the same degree of flexion. Investigators expect that other radiological targets for assessing patellofemoral instability, e.g. in trochlear dysplasia patients will change between the different scan situations. In addition, investigators expect that the TT-TG distance measurement method has a high reproducibility of intra- and in-terobserver variation as well as over time with repeated scans. The reproducibility is expected to be at least as good or above existing 2D measurement methods on conventional scans. In patients with trochlear dysplasia, a greater TT-TG distance is expected than in healthy controls. In addition, differences in TT-TG distance between flexion/extension as well as between non-weight bearing and weight bearing condition are expected to be greater than in healthy controls. In addi-tion, investigators expect to be able to detect a correlation between controlled changes in the position of the foot which will lead to passive changes in the TT-TG distance.
The purpose of the study is:
- To investigate changes in TT-TG distance in CBCT scans of the knee joint, in healthy con-trols as well as in trochlear dysplasia patients, in two predefined degrees of flexion (0 ° i.e. fully stretched position; 20 ° flexion), in respectively weight-bearing loaded and unloaded position
- To investigate the day-to-day reliability of the measured TT-TG distance, knee flexion angle and other radiological measurements regarding patellofemoral instability, at two separate CBCT scan sessions in patients with trochlear dysplasia compared with healthy controls
- To investigate changes in the TT-TG distance in trochlear dysplasia patients before and after surgery in terms of evaluation of the patellofemoral instability
- Conditions
- Musculoskeletal Diseases
- Being tested
- Weight bearing CT
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight bearing CTDiagnostic test
Weight bearing CT in loaded and unloaded positions
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Weight bearing CT in fully extended and flexed (20 degrees) position, loaded and unloaded, respectively. Receives: Diagnostic Test: Weight bearing CT | |
| Trochlear dysplasia | Weight bearing CT in fully extended and flexed (20 degrees) position, loaded and unloaded, respectively. Receives: Diagnostic Test: Weight bearing CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of patellofemoral indices
Intra and interrater reliability and day to day repeatability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Sep 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies 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
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Brinch, Bispebjerg Hospital
- Investigators
- Signe Brinch, MD, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432609
- Sponsor's protocol ID
- H-20068116
- Status last verified
- Aug 2024
- First submitted
- 21 Jun 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization and Reproducibility Regarding Scanning Procedures and Measurements of Weight-bearing Cone Beam CT in the Lower Extremity
- ClinicalTrials.gov ID
- NCT05432609
- Acronym / sponsor ID
- H-20068116
- Conditions
- Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 27 Jun 2022 (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.
Cone Beam CT (CBCT) of the knee is gaining interest, especially regarding patients suffering from patellofemoral instability. With this study investigators wish to investigate the day-to-day, test-retest reliability of weight bearing (WB) and non-weight bearing (NWB) CBCT of the knee in healthy participants and patients suffering from trochlear dysplasia. The participants and patients will be scanned in the following positions: 0° WB, 0° NWB, 20° WB, 20° NWB on two separate days. The trochlear dysplasia patients will furthermore be scanned 6 months postoperatively.
The aim is to develop af protocol on how to both position patients during weight bearing scannings as well as a protocol on how to prepare the cross sectional images before measurements.
Detailed description
Investigators expect that scans performed with CBCT will show a clear change in the TT-TG distance when comparing scans performed in two different degrees of flexion of the knee. Investigators expect a discrete change in the TT-TG distance between non-weight bearing and weight-bearing state of the same degree of flexion. Investigators expect that other radiological targets for assessing patellofemoral instability, e.g. in trochlear dysplasia patients will change between the different scan situations. In addition, investigators expect that the TT-TG distance measurement method has a high reproducibility of intra- and in-terobserver variation as well as over time with repeated scans. The reproducibility is expected to be at least as good or above existing 2D measurement methods on conventional scans. In patients with trochlear dysplasia, a greater TT-TG distance is expected than in healthy controls. In addition, differences in TT-TG distance between flexion/extension as well as between non-weight bearing and weight bearing condition are expected to be greater than in healthy controls. In addi-tion, investigators expect to be able to detect a correlation between controlled changes in the position of the foot which will lead to passive changes in the TT-TG distance.
The purpose of the study is:
- To investigate changes in TT-TG distance in CBCT scans of the knee joint, in healthy con-trols as well as in trochlear dysplasia patients, in two predefined degrees of flexion (0 ° i.e. fully stretched position; 20 ° flexion), in respectively weight-bearing loaded and unloaded position
- To investigate the day-to-day reliability of the measured TT-TG distance, knee flexion angle and other radiological measurements regarding patellofemoral instability, at two separate CBCT scan sessions in patients with trochlear dysplasia compared with healthy controls
- To investigate changes in the TT-TG distance in trochlear dysplasia patients before and after surgery in terms of evaluation of the patellofemoral instability
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Weight bearing CTWeight bearing CT in fully extended and flexed (20 degrees) position, loaded and unloaded, respectively. |
| Trochlear dysplasia | – | Diagnostic Test: Weight bearing CTWeight bearing CT in fully extended and flexed (20 degrees) position, loaded and unloaded, respectively. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants recruited amongst employees in the ER, Bispebjerg-Frederiksberg Hospital Trochlear dysplasia patients selected from the sports surgery unit, Bispebjerg-Frederiksberg Hospital
Key inclusion criteria (8 listed)
- Substudy 1:Healthy
- Male or female aged 18-39 years
- Must be able to stand on one leg for 30 seconds
- Substudy 2
- Diagnosed with trochlear dysplasia, in addition healthy
Key exclusion criteria (10 listed)
- Substudy 1
- Current knee injury and / or knee pain.
- Known rheumatoid and / or connective tissue disease.
- Previous treatment requiring knee injury and / or knee surgery.
- Pregnancy
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 |
|---|---|---|
| Weight bearing CTWeight bearing CT in loaded and unloaded positions | Diagnostic test | Healthy, Trochlear dysplasia |
Primary outcome
Measurement of patellofemoral indices
Time frame: 1 year
Intra and interrater reliability and day to day repeatability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
Signe Brinch, MD principal investigator
University Hospital Bispebjerg and Frederiksberg
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 Musculoskeletal Diseases, run by Bispebjerg Hospital at 1 site in Denmark.
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 8 inclusion and 10 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 23 Aug 2024. 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 Denmark. 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?
Results are not available in the source record.
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?
Measurement of patellofemoral indices (time frame: 1 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 23 Aug 2024.