An observational study in Patellar Dislocation, Patellar Dislocation, Recurrent and Patellofemoral Maltracking, sponsored by Radboud University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Radboud University Medical Center · Observational
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.
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.
41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.
This study's enrollment of 11 is below the median of 100 across 15 observational studies indexed under Patellar Dislocation.
Browse Patellar Dislocation studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients 16 years and older with recurrent patellofemoral instability who received a MPFL reconstruction with or without TTT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Recurrent patellofemoral instability, for which:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in patient-reported outcomes
Pre- and postoperative difference in patient reported outcome measures (PROMs)
Time frame: 6 weeks preoperative to 6 months postoperative
Change in patient-reported outcomes.
Pre- and postoperative difference in patient reported outcome measures (PROMs)
Time frame: 6 weeks preoperative to 12 months postoperative
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.
Time frame: preoperative, 12-~24 months postoperative
Ran from Feb 2023 to primary completion in May 2025, 27 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radboud University Medical Center →