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

Not Applicable

Recruiting

• Conditions: Patellar Dislocation
• Interventions: Procedure: Quadriceps graft

• Registration Number: NCT05706363
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-31
• Primary Completion: 2024-06-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPFL reconstruction with gracillis graft	Quadriceps graft	MPFL reconstructrion with gracillis graft and screw fixation in femur
MPFL reconstruction with quadriceps graft	Quadriceps graft	MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur

Primary Outcome Measures

Name	Time	Method
Kujala (Anterior Knee Pain Scale)	24 month	Patient reported outcome score, 0=worst and 100=best

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99; 🇩🇰 Aarhus N, Denmark