Evaluating outcomes after a specific knee surgery for patellar dislocation
Difference in Patient Reported Outcomes and Patellar Tracking Before and After Isolated MPFL Reconstruction.
Radboud University Medical Center · NCT05547269
This study is testing a new knee surgery method for people with repeated kneecap dislocations to see if it improves their recovery and knee movement over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT05547269 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of a soft-tissue loop method for medial patellofemoral ligament (MPFL) reconstruction in patients with recurrent patellar dislocation. It will evaluate patient-reported outcomes and changes in patellar tracking using 4D CT imaging before and 12 months after the surgery. The study will involve 15 patients aged 16 and older who have undergone this specific surgical procedure at Radboud University Medical Center. The goal is to provide clinical insights into the effectiveness of this reconstruction method compared to existing techniques.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older with recurrent patellofemoral instability who are undergoing isolated MPFL reconstruction.
Not a fit: Patients under 16 years of age, pregnant individuals, those with a BMI over 35, or those unable to flex and extend their knee will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and outcomes for patients suffering from patellar dislocation.
How similar studies have performed: While there is a lack of consensus on the ideal MPFL reconstruction method, this specific approach has not been clinically evaluated before, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Miriam Boot
- Email: miriam.boot@radboudumc.nl
- Phone: 0243613918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patellar Dislocation, Patellar Dislocation, Recurrent, Patellofemoral Maltracking, 4DCT, MPFL reconstruction, Patellofemoral instability