Anterior Knee Pain SyndromeTTTfollow-upNCT05629754
10-year Follow-up After Tibial Tubercle Transposition
An observational study of Anterior Knee Pain Syndrome, run by Centre for Orthopaedic Research Alkmaar at 1 site in Netherlands.
Trial summary
Patellofemoral pain is a common complaint especially in young adults. It can be caused by patellar maltracking. Part of this is a patella alta. When patellar maltracking is the cause of the problem and conservative therapy fails, surgery, a tibial tuberosity transposition, may be considered. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- MRI, radiological assessment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Nov 2023to Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whom around 10 years ago presented with anterior knee pain and patella maltracking without instability, where conservative therapy failed and a TTT was performed, and who participated in the original cohort.
Who may be able to join
- Age between 18 and 80 years
- Participated in an earlier cohort study
- Underwent a tibial tubercle transposition between 2012 and 2015
- Preoperative MRI available
Who cannot join
- No preoperative MRI is available
- Patellar-related surgery after the initial surgery
- Female patients that are (expecting to be) pregnant
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815 JD
About this study
Official title: Long-term Outcomes and Development of Retropatellar Chondropathy After Tibial Tubercle Distomedialisation for Patellar Maltracking and Patella Alta Without Instability: 10 Year Follow-up of a Prospective Cohort
Patellofemoral pain is a common complaint especially in young adults. It can be caused by patellar maltracking. Part of this is a patella alta. When patellar maltracking is the cause of the problem and conservative therapy fails, surgery, a tibial tuberosity transposition, may be considered. Most research has been done in patients with recurrent patella luxation. However, in patients without luxation, research is scarce.
It is known that patients with patella alta have an increased risk of developing patellofemoral chondropathy due to increased pressure. With this study, we aim to investigate whether and how a tibial tuberosity transposition in patients with patella alta and no instability affects the degree of patellofemoral chondropathy and patient satisfaction after 10 years. This will allow us to educate patients regarding long-term outcomes better.
Read the detailed description
Anterior knee pain is a common complaint, especially in younger and active adults. An obvious source for anterior knee pain is patellar maltracking, which is often associated with patella alta (a high-riding patella). Due to maltracking, the cartilage of the patella can face a greater amount of pressure, which can cause cartilage damage. When conservative treatment fails, a surgical intervention can be considered. One of the surgical options is performing a tibial tubercle transfer (TTT), where the patella is being distalized and medialized. As a result, the improvement in patellar tracking will reduce the pressure on the retropatellar cartilage. The TTT has been proven effective in patients with patellar instability but less is known about patients without instability. Specifically, whether these patients face a higher risk of developing retropatellar cartilage damage ('retropatellar chondropathy') due to this intervention is currently unknown.
The primary aim of this study is to determine the incidence and the degree of retropatellar chondropathy 10 years after a TTT in patients with anterior knee pain without patellar instability. The secondary aim is to evaluate the long-term patient reported outcomes (PROMs) 10 years after a TTT in patients with anterior knee pain without patellar instability.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- MRI, radiological assessment
- Keywords
- Tibial tubercle transfer, Long-term follow-up
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI, radiological assessmentDiagnostic test
MRI and radiological assessment of the involved knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Outerbridge Classification
Degree of retropatellar cartilage damage
Measured: 10-year follow-up assessment
Secondary outcomes (4)
Patellar height
Patellar height measured by radiological assessment lateral view
Measured: 10-year follow-up assessment
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: 10-year follow-up assessment
Kujala Anterior Knee Pain Score (AKPS) questionnaire
The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format (e.g., no pain (5) to constant pain (0)). Total scores range from 0 to 100, with a higher score indicating less symptoms.
Measured: One measurement
Visual Analogue Scale (VAS) for pain
The pain VAS is a unidimensional measure of pain intensity, scored from 0 (no pain) to 100 (highest possible pain intensity).
Measured: 10-year follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start18 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Orthopaedic Research Alkmaar
- Sponsor type
- University, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep
- Responsible party
- Principal investigator, Joyce L Benner, PhD, Centre for Orthopaedic Research Alkmaar
- Investigators
- JL Benner, PhD, Principal investigator, Noordwest Ziekenhuisgroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629754
- Sponsor's protocol ID
- NL82613.029.22
- Acronym
- TTTfollow-up
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bayoumi T, van Duijvenbode DC, Benner JL, Boerma-Argelo KDS, Stavenuiter MHJ, van der List JP. Clinical Improvement Is Achieved Following Tibial Tubercle Distomedialization for Patellar Maltracking and Patella Alta Without Instability. Arthrosc Sports Med Rehabil. 2021 Jun 15;3(3):e845-e853. doi: 10.1016/j.asmr.2021.01.027. eCollection 2021 Jun.
PubMed 34195653
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes and Development of Retropatellar Chondropathy After Tibial Tubercle Distomedialisation for Patellar Maltracking and Patella Alta Without Instability: 10 Year Follow-up of a Prospective Cohort
- ClinicalTrials.gov ID
- NCT05629754
- Acronym / sponsor ID
- TTTfollow-up / NL82613.029.22
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Tibial tubercle transfer, Long-term follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre for Orthopaedic Research AlkmaarUniversity, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep
- Study start
- 18 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Nov 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.
Patellofemoral pain is a common complaint especially in young adults. It can be caused by patellar maltracking. Part of this is a patella alta. When patellar maltracking is the cause of the problem and conservative therapy fails, surgery, a tibial tuberosity transposition, may be considered. Most research has been done in patients with recurrent patella luxation. However, in patients without luxation, research is scarce.
It is known that patients with patella alta have an increased risk of developing patellofemoral chondropathy due to increased pressure. With this study, we aim to investigate whether and how a tibial tuberosity transposition in patients with patella alta and no instability affects the degree of patellofemoral chondropathy and patient satisfaction after 10 years. This will allow us to educate patients regarding long-term outcomes better.
Detailed description
Anterior knee pain is a common complaint, especially in younger and active adults. An obvious source for anterior knee pain is patellar maltracking, which is often associated with patella alta (a high-riding patella). Due to maltracking, the cartilage of the patella can face a greater amount of pressure, which can cause cartilage damage. When conservative treatment fails, a surgical intervention can be considered. One of the surgical options is performing a tibial tubercle transfer (TTT), where the patella is being distalized and medialized. As a result, the improvement in patellar tracking will reduce the pressure on the retropatellar cartilage. The TTT has been proven effective in patients with patellar instability but less is known about patients without instability. Specifically, whether these patients face a higher risk of developing retropatellar cartilage damage ('retropatellar chondropathy') due to this intervention is currently unknown.
The primary aim of this study is to determine the incidence and the degree of retropatellar chondropathy 10 years after a TTT in patients with anterior knee pain without patellar instability. The secondary aim is to evaluate the long-term patient reported outcomes (PROMs) 10 years after a TTT in patients with anterior knee pain without patellar instability.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whom around 10 years ago presented with anterior knee pain and patella maltracking without instability, where conservative therapy failed and a TTT was performed, and who participated in the original cohort.
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- Participated in an earlier cohort study
- Underwent a tibial tubercle transposition between 2012 and 2015
- Preoperative MRI available
Key exclusion criteria (3 listed)
- No preoperative MRI is available
- Patellar-related surgery after the initial surgery
- Female patients that are (expecting to be) pregnant
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 |
|---|---|---|
| MRI, radiological assessmentMRI and radiological assessment of the involved knee | Diagnostic test | – |
Primary outcome
Modified Outerbridge Classification
Time frame: 10-year follow-up assessment
Degree of retropatellar cartilage damage
4 secondary outcomes
Patellar height
Time frame: 10-year follow-up assessment
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time frame: 10-year follow-up assessment
Kujala Anterior Knee Pain Score (AKPS) questionnaire
Time frame: One measurement
Visual Analogue Scale (VAS) for pain
Time frame: 10-year follow-up assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Background: PubMed 34195653Bayoumi T, van Duijvenbode DC, Benner JL, Boerma-Argelo KDS, Stavenuiter MHJ, van der List JP. Clinical Improvement Is Achieved Following Tibial Tubercle Distomedialization for Patellar Maltracking and Patella Alta Without Instability. Arthrosc Sports Med Rehabil. 2021 Jun 15;3(3):e845-e853. doi: 10.1016/j.asmr.2021.01.027. eCollection 2021 Jun.
- Individual participant dataSharing planned: Undecided
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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.
JL Benner, PhD principal investigator
Noordwest Ziekenhuisgroep
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 Anterior Knee Pain Syndrome, run by Centre for Orthopaedic Research Alkmaar at 1 site in Netherlands.
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 4 inclusion and 3 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 24 Nov 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 Netherlands. 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?
Modified Outerbridge Classification (time frame: 10-year follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629754, which also lists 1 linked publication.
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 Nov 2023.