Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05547269
Other study ID # 4DCT-PROMs-MPFLr
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 17, 2023
Est. completion date December 1, 2025

Study information

Verified date November 2023
Source Radboud University Medical Center
Contact Miriam Boot
Phone 0243613918
Email miriam.boot@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 and many different variations exist. For a reliable comparison, each MPFL reconstruction method should be evaluated clinically. Within the Radboudumc, a soft-tissue loop method is used for MPFL reconstruction. The method has not yet been evaluated clinically, and the difference in patella tracking is largely unknown. Objective: Evaluate pre- and postoperative reported outcomes in patients receiving an isolated 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. Study design: Prospective single centre observational study Study population: 15 patients with recurrent patellofemoral instability who have received an isolated soft-tissue loop MPFL reconstruction 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 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 a the regular 12 month check-up appointment day so patients do not have to come to the Radboudumc for the CT scan on itself. The preoperative 4D CT scan and PROMS that will be used in this study are part of standard care. CT scans exposes patients to radiation. For this study the level of radiation is estimated as an negligible risk. No additional risks are associated with this study. Potential burdens for patients are predominantly time 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Radboudumc Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04554212 - Blood Flow Restriction Training After Patellar INStability N/A
Recruiting NCT05243134 - The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Recruiting NCT02267564 - MPFL Reconstruction With or Without Tibial Tubercle Transfer N/A
Active, not recruiting NCT04294199 - Effect of Early Range of Motion Following First Time Patellar Dislocation N/A
Recruiting NCT06086080 - Non-operative Treatment in First-time Patellar Dislocation N/A
Active, not recruiting NCT03076008 - The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction
Recruiting NCT04607538 - The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.
Enrolling by invitation NCT04673188 - Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability N/A
Recruiting NCT05706363 - Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) N/A
Completed NCT03040232 - Clinical Outcomes Following Patellar Dislocation in Young Athletes N/A
Completed NCT00551668 - A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation N/A
Completed NCT02569931 - The Unstable Kneecap - the Impact of Anatomy on Function N/A
Active, not recruiting NCT01344915 - Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation N/A
Completed NCT03304119 - Torsion of the Tibial Tuberosity, a New Factor of Patellar Instability?