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

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Clalit Health Services

Status

Unknown

Conditions

Patella, Familial Recurrent Dislocation Of

Treatments

Procedure: Surgical treatment for recurrent patellar instability

Study type

Interventional

Funder types

Other

Identifiers

NCT02480959
0041-15-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

15 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Medial plication
Other group
Description:
Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication
Treatment:
Procedure: Surgical treatment for recurrent patellar instability
MPFL reconstruction
Other group
Description:
Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft
Treatment:
Procedure: Surgical treatment for recurrent patellar instability

Trial contacts and locations

1

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Central trial contact

DROR LINDNER, M.D.; IFTACH HETSRONI, M.D.

Data sourced from clinicaltrials.gov

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