Patellar Dislocation Clinical Trial
Official title:
Difference in Patient Reported Outcomes and Patellar Tracking Before and After Isolated MPFL Reconstruction.
Patellar dislocations cause pain and functional decline in adolescents, which can be restored by a MPFL reconstruction. 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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Age of 16 years and older. - Recurrent patellofemoral instability, for which: 1. the patient will receive a primary isolated MPFL reconstruction, or 2. the patient has received a primary isolated MPFL reconstruction <12 months ago, on the condition that the patient has completed his/her questionnaires and received a usable preoperative 4D CT scan . - Informed consent of the patient. Exclusion Criteria: - Patients below an age of 16 years. - Patients that are pregnant. - BMI > 35 - Patients that are unable to actively flex and extend their knee. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in patient-reported outcomes. | Pre- and postoperative difference in patient reported outcome measures (PROMs) | 6 weeks preoperative to 6 months postoperative | |
Primary | Change in patient-reported outcomes. | Pre- and postoperative difference in patient reported outcome measures (PROMs) | 6 weeks preoperative to 12 months postoperative | |
Secondary | Difference in patellar tracking. | Difference between preoperative and 12 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. | ~6 weeks preoperative, 12 months postoperative |
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