Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used. It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 5, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
ExpectedOctober 3, 2025
September 1, 2025
6.9 years
January 5, 2023
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Kujala (Anterior Knee Pain Scale)
Patient reported outcome score, 0=worst and 100=best
24 month
Secondary Outcomes (6)
Donor site morbidity score, 0=worst and 100=best
24 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
24 month
Lysholm-Tegner (Activity Score)
24 month
Numerical Rating Scale (NRS-pain score)
24 month
Knee pain
24 month
- +1 more secondary outcomes
Study Arms (2)
MPFL reconstruction with gracillis graft
ACTIVE COMPARATORMPFL reconstructrion with gracillis graft and screw fixation in femur
MPFL reconstruction with quadriceps graft
EXPERIMENTALMPFL reconstructrion with quadriceps graft and suture anchor fixation in femur
Interventions
Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor
Eligibility Criteria
You may qualify if:
- Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
- The growth zones must be found closed - verified by MRI scan
You may not qualify if:
- Patients with known rheumatoid arthritis.
- Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
- Inability to follow a normal rehabilitation regime.
- Previous ligament surgery in injured knees.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 5, 2023
First Posted
January 31, 2023
Study Start
July 1, 2017
Primary Completion
June 5, 2024
Study Completion (Estimated)
July 30, 2026
Last Updated
October 3, 2025
Record last verified: 2025-09