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Clinical Trials/NCT02480959
NCT02480959
Unknown
N/A

Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction

Meir Medical Center1 site in 1 country30 target enrollmentAugust 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patella, Familial Recurrent Dislocation Of
Sponsor
Meir Medical Center
Enrollment
30
Locations
1
Primary Endpoint
Kujala knee outcome score
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
December 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

  • 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)
  • Single hop test(Between two and five years after surgery)
  • Patellar apprehension test(Between two and five years after surgery)
  • Tenger activity level score(Between two and five years after surgery)
  • 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)

Study Sites (1)

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