MPFL Reconstruction Versus Rehabilitation

NCT06926699 | Not Yet Recruiting DMC

• 2 other identifiers: ANTI-GLIDE$25000
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

MPFL; Medial Patellofemoral Ligament Reconstruction; Patellar dislocation

Outcome Measures

Primary Outcomes (1)

• Recurrent dislocation and instability

  1. The rate of recurrent patellar dislocation at 12 months 2. The rate of recurrent subjective instability at 12 months 3. The rate of recurrent instability requiring surgical management at 12 months

  12 months post- start of intervention

Secondary Outcomes (6)

• Visual Analogue Score (VAS)

  12 months post- start of intervention

• Kujala Anterior Knee Pain Scale

  12 months post- start of intervention

• Banff Patellofemoral Instability Index 2.0 (BPII2.0)

  12 months post- start of intervention

• Tegner Activity Scale

  12 months post- start of intervention

• Adverse Events

  12 months post- start of intervention

Study Arms (2)

Medial Patellofemoral Ligament Reconstruction

EXPERIMENTAL

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.

Procedure: Medial Patellofemoral Ligament Reconstruction

Rehabilitation

ACTIVE COMPARATOR

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.

Other: Rehabilitation

Interventions

Medial Patellofemoral Ligament Reconstruction PROCEDURE

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.

Medial Patellofemoral Ligament Reconstruction

Rehabilitation OTHER

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.

Rehabilitation

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Provision of informed consent or parental consent

You may not qualify if:

• 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
• Evidence of severe trochlear dysplasia on MRI as determined by Dejour classification type D dysplasia
• Loose bodies or osteochondral fractures as confirmed on MRI
• A neurovascular injury of the affected leg
• Patients who will likely have problems, in the judgment of the investigator, with maintaining follow-up
• Any other reason(s) the investigator feels is relevant for excluding the patient

Sponsors & Collaborators

• McMaster University: lead
• Arthroscopy Association of North America: collaborator

MeSH Terms

Conditions

Patella Fracture; Patellar Dislocation

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Olufemi Ayeni R Dr. Ayeni, MD PhD FRCSC

CONTACT

9055212100; femiayeni@gmail.com

Prushoth Vivekanantha Dr. Vivekanantha, MD

CONTACT

519 991 1325; prushoth.vivekanantha@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share