About this trial
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:
Eligibility criteria
Qualifiers
Males and female patients under the age of 25 inclusive but greater than 10 years of age inclusive
Patients with first-time traumatic lateral patellar dislocation presenting within 6 months from time of injury
Lateral patellar dislocation confirmed by radiography, MRI demonstrating sequela of lateral patellar dislocation after injury to the knee, demonstration of patellar apprehension, J-sign or patellar glide grade 3 or greater on physical exam following injury to the knee
Patients who have the ability to speak, understand, and read English
Disqualifiers
Previous dislocation episodes or instability of the affected patella
Previous surgeries involving the affected knee
History or clinical exam findings of generalized ligamentous laxity (defined as Beighton score of 4 or more points)
TT-TG distance >20mm as determined by MRI
Trial design
Treatments tested in this trial
- Medial Patellofemoral Ligament Reconstruction
- Rehabilitation
Treatment groups
Locations
Sponsors and collaborators
McMaster University
Lead sponsor
Arthroscopy Association of North America
Collaborator