Patellar DislocationNCT05547269
PROMs and Patellar Tracking After MPFL Reconstruction With or Without Tibial Tuberosity Transposition
An observational study of Patellar Dislocation and Patellar Dislocation, Recurrent, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Patellar dislocations cause pain and functional decline in adolescents, which can be restored by a MPFL reconstruction with or without tibial tuberosity transposition. Yet, many reconstruction methods are being used clinically as consensus on the ideal MPFL reconstruction method is lacking. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Patellar Dislocation, Patellar Dislocation, Recurrent, Patellofemoral Maltracking
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2023to 20 May 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients 16 years and older with recurrent patellofemoral instability who received a MPFL reconstruction with or without TTT.
Who may be able to join
- Age of 16 years and older.
- Recurrent patellofemoral instability, for which:
- the patient will receive a MPFL reconstruction with or without TTT, or
- the patient has received a MPFL reconstruction with or without TTT , on the condition that the patient has a usable preoperative 4D CT scan.
- Informed consent of the patient.
Who cannot join
- Patients below an age of 16 years.
- Patients that are pregnant.
- BMI > 35
- Patients that are unable to actively flex and extend their knee.
- Patellar stabilizing surgery other than the usual MPFL reconstruction with or without TTT. This includes: trochleoplasty, static MPFL reconstruction, isolated TTT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Difference in Patient Reported Outcomes and Patellar Tracking Before and After MPFL Reconstruction With or Without Tibial Tuberosity Transposition
Patellar dislocations cause pain and functional decline in adolescents, which can be restored by a MPFL reconstruction with or without tibial tuberosity transposition. Yet, many reconstruction methods are being used clinically as consensus on the ideal MPFL reconstruction method is lacking. We propose a soft-tissue loop reconstruction method which potentially decreases the risk for of iatrogenic fracture of the patella and prevents femoral tunnel malposition.
Read the detailed description
Rationale: A patellar dislocation is one of the most common acute knee disorders in children and adolescents, causing pain and functional decline. In order to restore healthy kinematics and relieve pain, patients can receive a MPFL reconstruction. Still, there is no consensus on the ideal MPFL reconstruction method. Within the Radboudumc, a dynamic soft-tissue loop method is used for MPFL reconstruction. The method minimizes the risk of iatrogenic fracture of the patella and prevents nonanatomic tracking due to femoral tunnel malposition. Yet, the technique has not been evaluated clinically.
Objective: Evaluate pre- and postoperative reported outcomes in patients receiving an soft tissue loop MPFL reconstruction for the treatment of patellar instability. Additionally, it is aimed to investigate the difference in patella tracking before and ~12 months after surgery measured with 4D CT imaging in patients receiving an MPFL reconstruction with or without TTT for the treatment of patellar instability.
Study design: Prospective single centre observational study.
Study population: 20 patients with recurrent patellofemoral instability who have received or will receive an soft-tissue loop MPFL reconstruction with or without TTT within the Radboudumc.
Main study parameters/endpoints: the main study parameter is the pre- and postoperative difference in patient reported outcome measures (PROMs). The secondary aim is to assess changes in patellar tracking (measured before and 12 months (to ~ 24 months) after surgery).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will undergo a 4D CT scan of their knees after their surgery. Whenever possible, the CT scans will be planned during the regular 12 month check-up appointment day so patients do not have to come separately to the Radboudumc for the CT scan. When the operation was > 12 months ago and patients do have to come to the Radboudumc for the CT scan they will be compensated for their travel expenses with a bol.com gift card of 100 euros. The preoperative 4D CT scan and PROMS that will be used in this study are part of standard care. CT scanning exposes patients to radiation. For this study the level of radiation is estimated as an intermediate level of risk. No additional risks are associated with this study. Potential burdens for patients are predominantly time (for which they will be compensated with a gift card of 100 euros in case they have to come to the Radboudumc for the scan) and additional radiation exposure. No direct personal health benefit is expected. However, the knowledge generated with this study is expected to benefit future patients who need to undergo a MPFL reconstruction with or without TTT.
- Keywords
- 4DCT, MPFL reconstruction, Patellofemoral instability
- Medical subject headings
- Patellar Dislocation, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported outcomes
Pre- and postoperative difference in patient reported outcome measures (PROMs)
Measured: 6 weeks preoperative to 6 months postoperative
Change in patient-reported outcomes.
Pre- and postoperative difference in patient reported outcome measures (PROMs)
Measured: 6 weeks preoperative to 12 months postoperative
Secondary outcomes (1)
Difference in patellar tracking.
Difference between preoperative and 12-24 months postoperative in patellar tracking. This will be measured with 4D CT imaging and quantified by the patellar tilt and shift. The preoperative 4D CT scan is part of standard care.
Measured: preoperative, 12-~24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start17 Feb 2023
- Primary completion20 May 2025
- Study completion20 May 2025
Why it stopped: Due to insufficient participant enrollment. Recruitment significantly lagged behind projections, and a decline in eligible patients at the study site made it unlikely that the study could be successfully completed within a reasonable timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547269
- Sponsor's protocol ID
- 4DCT-PROMs-MPFLr
- Status last verified
- May 2025
- First submitted
- 12 Sep 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Patient Reported Outcomes and Patellar Tracking Before and After MPFL Reconstruction With or Without Tibial Tuberosity Transposition
- ClinicalTrials.gov ID
- NCT05547269
- Acronym / sponsor ID
- 4DCT-PROMs-MPFLr
- Keywords
- 4DCT, MPFL reconstruction, Patellofemoral instability
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to insufficient participant enrollment. Recruitment significantly lagged behind projections, and a decline in eligible patients at the study site made it unlikely that the study could be successfully completed within a reasonable timeframe.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 21 Sep 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.
Patellar dislocations cause pain and functional decline in adolescents, which can be restored by a MPFL reconstruction with or without tibial tuberosity transposition. Yet, many reconstruction methods are being used clinically as consensus on the ideal MPFL reconstruction method is lacking. We propose a soft-tissue loop reconstruction method which potentially decreases the risk for of iatrogenic fracture of the patella and prevents femoral tunnel malposition.
Detailed description
Rationale: A patellar dislocation is one of the most common acute knee disorders in children and adolescents, causing pain and functional decline. In order to restore healthy kinematics and relieve pain, patients can receive a MPFL reconstruction. Still, there is no consensus on the ideal MPFL reconstruction method. Within the Radboudumc, a dynamic soft-tissue loop method is used for MPFL reconstruction. The method minimizes the risk of iatrogenic fracture of the patella and prevents nonanatomic tracking due to femoral tunnel malposition. Yet, the technique has not been evaluated clinically.
Objective: Evaluate pre- and postoperative reported outcomes in patients receiving an soft tissue loop MPFL reconstruction for the treatment of patellar instability. Additionally, it is aimed to investigate the difference in patella tracking before and ~12 months after surgery measured with 4D CT imaging in patients receiving an MPFL reconstruction with or without TTT for the treatment of patellar instability.
Study design: Prospective single centre observational study.
Study population: 20 patients with recurrent patellofemoral instability who have received or will receive an soft-tissue loop MPFL reconstruction with or without TTT within the Radboudumc.
Main study parameters/endpoints: the main study parameter is the pre- and postoperative difference in patient reported outcome measures (PROMs). The secondary aim is to assess changes in patellar tracking (measured before and 12 months (to ~ 24 months) after surgery).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will undergo a 4D CT scan of their knees after their surgery. Whenever possible, the CT scans will be planned during the regular 12 month check-up appointment day so patients do not have to come separately to the Radboudumc for the CT scan. When the operation was > 12 months ago and patients do have to come to the Radboudumc for the CT scan they will be compensated for their travel expenses with a bol.com gift card of 100 euros. The preoperative 4D CT scan and PROMS that will be used in this study are part of standard care. CT scanning exposes patients to radiation. For this study the level of radiation is estimated as an intermediate level of risk. No additional risks are associated with this study. Potential burdens for patients are predominantly time (for which they will be compensated with a gift card of 100 euros in case they have to come to the Radboudumc for the scan) and additional radiation exposure. No direct personal health benefit is expected. However, the knowledge generated with this study is expected to benefit future patients who need to undergo a MPFL reconstruction with or without TTT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients 16 years and older with recurrent patellofemoral instability who received a MPFL reconstruction with or without TTT.
Key inclusion criteria (5 listed)
- Age of 16 years and older.
- Recurrent patellofemoral instability, for which:
- Informed consent of the patient.
Key exclusion criteria (5 listed)
- Patients below an age of 16 years.
- Patients that are pregnant.
- BMI > 35
- Patients that are unable to actively flex and extend their knee.
- Patellar stabilizing surgery other than the usual MPFL reconstruction with or without TTT. This includes: trochleoplasty, static MPFL reconstruction, isolated TTT
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
Change in patient-reported outcomes
Time frame: 6 weeks preoperative to 6 months postoperative
Pre- and postoperative difference in patient reported outcome measures (PROMs)
Change in patient-reported outcomes.
Time frame: 6 weeks preoperative to 12 months postoperative
Pre- and postoperative difference in patient reported outcome measures (PROMs)
1 secondary outcome
Difference in patellar tracking.
Time frame: preoperative, 12-~24 months postoperative
Results and safety
The study was stopped early (reason given: Due to insufficient participant enrollment. Recruitment significantly lagged behind projections, and a decline in eligible patients at the study site made it unlikely that the study could be successfully completed within a reasonable timeframe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patellar Dislocation and Patellar Dislocation, Recurrent, run by Radboud University Medical Center 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Jun 2025. 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?
The study was stopped early (reason given: Due to insufficient participant enrollment. Recruitment significantly lagged behind projections, and a decline in eligible patients at the study site made it unlikely that the study could be successfully completed within a reasonable timeframe.). 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?
Change in patient-reported outcomes (time frame: 6 weeks preoperative to 6 months 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 6 Jun 2025.