Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL)

Comparison of Two Graft Choices in Mediale Patellofemoral Ligament Reconstruction (MPFL) - A Randomized Controlled Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Patellar Dislocation
• Intervention / Treatment: Procedure: Quadriceps graft

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MPFL reconstruction with gracillis graft; MPFL reconstructrion with gracillis graft and screw fixation in femur	Procedure: Quadriceps graft; Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor
Experimental: MPFL reconstruction with quadriceps graft; MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur	Procedure: Quadriceps graft; Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kujala (Anterior Knee Pain Scale)	Patient reported outcome score, 0=worst and 100=best	24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor site morbidity score, 0=worst and 100=best	Patient reported outcome score	24 month
Knee injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome score, 0=worst and 100=best	24 month
Lysholm-Tegner (Activity Score)	Patient reported outcome score, 0=worst and 100=best	24 month
Numerical Rating Scale (NRS-pain score)	Patient reported outcome score, 0=Best and 10=worst	24 month
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)	24 month
Patella Re-luxation sensation	Question about how often the patella has dislocated after the surgery. (no dislocation, 1-2 dislocation/md, more dislocation).	24 month

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): June 5, 2024
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Leg Injuries; Knee Injuries; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: Danish EC: 1-10-72-75-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No