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NCT Number: NCT05706363

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Patellar Dislocation Joint Diseases Joint Dislocations Knee Injuries Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quadriceps graft

Procedure

Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor

Primary outcomes

  1. Kujala (Anterior Knee Pain Scale)

    Time frame: 24 month

    Patient reported outcome score, 0=worst and 100=best

Secondary outcomes

  1. Donor site morbidity score, 0=worst and 100=best

    Time frame: 24 month

    Patient reported outcome score

  2. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 24 month

    Patient reported outcome score, 0=worst and 100=best

  3. Lysholm-Tegner (Activity Score)

    Time frame: 24 month

    Patient reported outcome score, 0=worst and 100=best

  4. Numerical Rating Scale (NRS-pain score)

    Time frame: 24 month

    Patient reported outcome score, 0=Best and 10=worst

  5. Knee pain

    Time frame: 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)

  6. Patella Re-luxation sensation

    Time frame: 24 month

    Question about how often the patella has dislocated after the surgery. (no dislocation, 1-2 dislocation/md, more dislocation).

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Jan 31, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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