Back to resultsComparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
Primary Purpose
Patellar Dislocation
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Quadriceps graft
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Dislocation
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Division of Sports Trauma, Palle Juul-Jensens Boulevard 99Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MPFL reconstruction with gracillis graft
MPFL reconstruction with quadriceps graft
Arm Description
MPFL reconstructrion with gracillis graft and screw fixation in femur
MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur
Outcomes
Primary Outcome Measures
Kujala (Anterior Knee Pain Scale)
Patient reported outcome score, 0=worst and 100=best
Secondary Outcome Measures
Donor site morbidity score, 0=worst and 100=best
Patient reported outcome score
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome score, 0=worst and 100=best
Lysholm-Tegner (Activity Score)
Patient reported outcome score, 0=worst and 100=best
Numerical Rating Scale (NRS-pain score)
Patient reported outcome score, 0=Best and 10=worst
Knee pain
Palpatory pain in relation to graft fixation in femur on a four-point likert scale (no pain, mild pain, moderate pain, severe pain)
Patella Re-luxation sensation
Question about how often the patella has dislocated after the surgery. (no dislocation, 1-2 dislocation/md, more dislocation).
Full Information
NCT ID
NCT05706363
First Posted
January 5, 2023
Last Updated
January 21, 2023
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05706363
Brief Title
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
Official Title
Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Standard: Gracillis graft
Intervention: Quadriceps graft
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MPFL reconstruction with gracillis graft
Arm Type
Active Comparator
Arm Description
MPFL reconstructrion with gracillis graft and screw fixation in femur
Arm Title
MPFL reconstruction with quadriceps graft
Arm Type
Experimental
Arm Description
MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur
Intervention Type
Procedure
Intervention Name(s)
Quadriceps graft
Intervention Description
Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor
Primary Outcome Measure Information:
Title
Kujala (Anterior Knee Pain Scale)
Description
Patient reported outcome score, 0=worst and 100=best
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Donor site morbidity score, 0=worst and 100=best
Description
Patient reported outcome score
Time Frame
24 month
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
Patient reported outcome score, 0=worst and 100=best
Time Frame
24 month
Title
Lysholm-Tegner (Activity Score)
Description
Patient reported outcome score, 0=worst and 100=best
Time Frame
24 month
Title
Numerical Rating Scale (NRS-pain score)
Description
Patient reported outcome score, 0=Best and 10=worst
Time Frame
24 month
Title
Knee pain
Description
Palpatory pain in relation to graft fixation in femur on a four-point likert scale (no pain, mild pain, moderate pain, severe pain)
Time Frame
24 month
Title
Patella Re-luxation sensation
Description
Question about how often the patella has dislocated after the surgery. (no dislocation, 1-2 dislocation/md, more dislocation).
Time Frame
24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Lind, Professor
Phone
+45 30248244
Email
martinlind@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Torsten Nielsen, BSC
Phone
+45 40491184
Email
torsne@rm.dk
Facility Information:
Facility Name
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Lind, Professor
Phone
+45 30248244
Email
martinlind@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Torsten Nielsen, coordinator
Phone
+45 40491184
Email
torsne@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)
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