Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Meir Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Kujala knee outcome score
Study Overview
Brief Summary
The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.
Detailed Description
Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrent lateral patellar instability has been described by the patient
- •Imaging criteria include:
- •TT-TG distance (on CT or MRI) is between 10-20 mm
- •Insall-Salvati Index is between 0.9 - 1.2
- •Trochlea angle is lower than 145 degrees
Exclusion Criteria
- •Only a single event of lateral patellar instability occured
- •Imaging criteria include:
- •TT-TG distance (on CT or MRI) is below 10 mm or above 20 mm
- •Insall-Salvati Index is below 0.9 or above 1.2
- •Trochlea angle is above 145 degrees
- •Other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs
- •Significant ligamentous injuries of the knees, including cruciate and collateral injuries, as well as meniscal injuries that interfere with function
Arms & Interventions
Medial plication
Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication
Intervention: Surgical treatment for recurrent patellar instability (Procedure)
MPFL reconstruction
Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft
Intervention: Surgical treatment for recurrent patellar instability (Procedure)
Outcomes
Primary Outcomes
Kujala knee outcome score
Time Frame: Between two and five years after surgery
A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms
Secondary Outcomes
- Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage(Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month)
- Marx activity level score(Between two and five years after surgery)
- Side-to-side hop test(Between two and five years after surgery)
- International Knee Documentation Committee subjective outcome score(Between two and five years after surgery)
- Visual Analogue Scale(Between two and five years after surgery)
- Tenger activity level score(Between two and five years after surgery)
- Single hop test(Between two and five years after surgery)
- Patellar apprehension test(Between two and five years after surgery)