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

Patellar Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706363
• Other study ID #: Danish EC: 1-10-72-75-17
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: April 30, 2026

Study information

• Verified date: January 2024
• Source: Aarhus University Hospital
• Contact: Martin Lind, Professor
• Phone: +45 30248244
• Email: martinlind[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellar Dislocation

Intervention

Procedure:
• Quadriceps graft
Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor

Locations

Country	Name	City	State
Denmark	Division of Sports Trauma, Palle Juul-Jensens Boulevard 99	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kujala (Anterior Knee Pain Scale)	Patient reported outcome score, 0=worst and 100=best	24 month
Secondary	Donor site morbidity score, 0=worst and 100=best	Patient reported outcome score	24 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Patient reported outcome score, 0=worst and 100=best	24 month
Secondary	Lysholm-Tegner (Activity Score)	Patient reported outcome score, 0=worst and 100=best	24 month
Secondary	Numerical Rating Scale (NRS-pain score)	Patient reported outcome score, 0=Best and 10=worst	24 month
Secondary	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
Secondary	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