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

NCT ID: NCT02480959

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Patella, Familial Recurrent Dislocation Of

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medial plication

Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication

Group Type OTHER

Surgical treatment for recurrent patellar instability

Intervention Type PROCEDURE

Either medial plication or MPFL reconstructuion surgery

MPFL reconstruction

Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft

Group Type OTHER

Surgical treatment for recurrent patellar instability

Intervention Type PROCEDURE

Either medial plication or MPFL reconstructuion surgery

Interventions

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Surgical treatment for recurrent patellar instability

Either medial plication or MPFL reconstructuion surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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IFTACH HETSRONI, M.D.

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

DROR LINDNER, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

IDAN ILSAR, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

MAZEN FALAH, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

NASSIM ALKRINAWI, M.D.

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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IFTACH HETSRONI, M.D.

Role: CONTACT

972-9-747 ext. 1182

DROR LINDNER, M.D.

Role: CONTACT

972-8-977 ext. 9443

Facility Contacts

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Iftach Hetsroni, M.D.

Role: primary

972-9-7471182

Other Identifiers

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0041-15-MMC

Identifier Type: -

Identifier Source: org_study_id

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