MPFL Reconstruction Versus Rehabilitation

Summary

This study involves patients between the ages of 16 and 25 and have been diagnosed with a first-time traumatic patellar dislocation within the past 3 months. McMaster University and the investigators are receiving compensation from the Arthroscopy Association of North America to cover the costs of conducting the study.

Dislocations of the kneecap or patella is often treated without surgery, however up to 50% of patients will unfortunately experience recurrent instability of the patella. These episodes can cause damage to the bones and cartilage in the knee, which can result in long-term knee pain or weakness. Therefore, there is increasing interest to consider treating the knee with surgery right away in this population.

The purpose of this study is to determine the effect of medial patellofemoral ligament (MPFL) reconstruction compared to rest and physical rehabilitation on the rate of repeat patella dislocation, pain, and knee function for patients with their first patellar dislocation. The investigators will follow patients for at least one year after assigned treatment is started. Outcomes will be measured using surveys and checking medical records over the course of the study. The pilot will test this research study on a smaller scale before conducting a larger study. Patients will not be asked to attend additional visits outside of their typical follow-up schedule with their doctor.

There will be 30 patients recruited in total for this pilot study. Not all patients diagnosed with a patellar dislocation will be eligible to participate. Participation will be required at 6 regularly scheduled appointments that patients would need to attend to see the surgeon (even if they were not in the trial), including the screening visit, surgery date (if randomized to that treatment), 2-week, 6-week, 3-month, 6-month, and 12-month follow-up visits. Patients will be asked how they feel via various questionnaires and should take no longer than 15-20 minutes to complete the research forms at each visit.

If patients agree to participate in this study, treatment will be determined by a process called randomization. Randomization means that the treatment the patient receives will be decided by chance like flipping a coin. Patients will have a 1-in-2 chance of receiving one of the following treatments:

Conditions

• Patellar (or Kneecap) Instability and Mal-alignment
• Patellar Dislocation

Interventions

PROCEDURE

Medial Patellofemoral Ligament Reconstruction

An initial evaluation with a diagnostic knee arthroscopy is done to ensure there are no loose bodies or osteochondral lesions missed on MRI that require removal or fixation. Graft harvest and preparation is done using either an autograft or allograft tendon as per a shared decision-making approach between the surgeon and patient. A 2cm longitudinal incision is made over the anteromedial aspect of the patella and dissection done between the second and third layers. Fixation (variable depending on surgeon preference) is performed over the proximal half of the patella. Another skin incision is then made over the medial femoral epicondyle with a guide pin passed through Schottle's point. The proximal femoral cortex is then drilled overtop of the guide pin to a diameter equal to the graft diameter with the remainder of the femoral tunnel drilled to 4.5mm.The graft ends are tied to the patellar fixation and shuttled through the second and third layers and fixed to the femur.

OTHER

Rehabilitation

Patients will be initially placed in a patellar stabilizing brace and told to remain non weight-bearing for the first two weeks. Subjects will be permitted to perform gentle ROM exercises while in the knee brace with progressive weight-bearing as tolerated permitted at the 2-week mark. Formal physiotherapy commences at 2-weeks post-enrollment, with a goal of return to activities or sport at 6-months post-enrollment.

Sponsors & Collaborators

• Arthroscopy Association of North America

  collaborator OTHER

• McMaster University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-12-31

Completion

2027-12-31