Study 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.
PROMs and Patellar Tracking After MPFL Reconstruction With or Without Tibial Tuberosity Transposition
Difference in Patient Reported Outcomes and Patellar Tracking Before and After MPFL Reconstruction With or Without Tibial Tuberosity Transposition
1 other identifier
observational
11
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2025
CompletedJune 6, 2025
May 1, 2025
2.3 years
September 12, 2022
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in patient-reported outcomes
Pre- and postoperative difference in patient reported outcome measures (PROMs)
6 weeks preoperative to 6 months postoperative
Change in patient-reported outcomes.
Pre- and postoperative difference in patient reported outcome measures (PROMs)
6 weeks preoperative to 12 months postoperative
Secondary Outcomes (1)
Difference in patellar tracking.
preoperative, 12-~24 months postoperative
Eligibility Criteria
Patients 16 years and older with recurrent patellofemoral instability who received a MPFL reconstruction with or without TTT.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 21, 2022
Study Start
February 17, 2023
Primary Completion
May 20, 2025
Study Completion
May 20, 2025
Last Updated
June 6, 2025
Record last verified: 2025-05