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Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability

Not Applicable
Conditions
Patella, Familial Recurrent Dislocation Of
Interventions
Procedure: Surgical treatment for recurrent patellar instability
Registration Number
NCT02480959
Lead Sponsor
Meir Medical Center
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MPFL reconstructionSurgical treatment for recurrent patellar instabilityPatient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft
Medial plicationSurgical treatment for recurrent patellar instabilityPatient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication
Primary Outcome Measures
NameTimeMethod
Kujala knee outcome scoreBetween two and five years after surgery

A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms

Secondary Outcome Measures
NameTimeMethod
Marx activity level scoreBetween two and five years after surgery

A validated international outcome score that evaluates highest level of sports activity

Side-to-side hop testBetween two and five years after surgery

Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds

International Knee Documentation Committee subjective outcome scoreBetween two and five years after surgery

A validated international outcome score that evaluates general knee functional outcome

Visual Analogue ScaleBetween two and five years after surgery

A validated international scale that evaluates level of pain

Tenger activity level scoreBetween two and five years after surgery

A validated international outcome score that evaluates highest level of sports activity

Single hop testBetween two and five years after surgery

Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance

Patellar apprehension testBetween two and five years after surgery

Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly

Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavageImmediately after surgery, for the duration of hospital stay, and until expected time of 1 month

Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage

Trial Locations

Locations (1)

Meir Medical Center

🇮🇱

Kfar Saba, Israel

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