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

Primary Purpose

Patella, Familial Recurrent Dislocation Of

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Surgical treatment for recurrent patellar instability
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patella, Familial Recurrent Dislocation Of

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Medial plication

MPFL reconstruction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

International Knee Documentation Committee subjective outcome score
A validated international outcome score that evaluates general knee functional outcome
Tenger activity level score
A validated international outcome score that evaluates highest level of sports activity
Marx activity level score
A validated international outcome score that evaluates highest level of sports activity
Visual Analogue Scale
A validated international scale that evaluates level of pain
Single hop test
Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance
Side-to-side hop test
Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds
Patellar apprehension test
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 lavage
Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage

Full Information

First Posted
June 8, 2015
Last Updated
March 1, 2020
Sponsor
Meir Medical Center
Collaborators
Rambam Health Care Campus, Hadassah Medical Organization, Assaf-Harofeh Medical Center, Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02480959
Brief Title
Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability
Official Title
Functional Outcome of Surgical Treatment for Recurrent Patellar Instability: A Prospective Comparative Study Between Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
Rambam Health Care Campus, Hadassah Medical Organization, Assaf-Harofeh Medical Center, Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patella, Familial Recurrent Dislocation Of

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medial plication
Arm Type
Other
Arm Description
Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication
Arm Title
MPFL reconstruction
Arm Type
Other
Arm Description
Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment for recurrent patellar instability
Intervention Description
Either medial plication or MPFL reconstructuion surgery
Primary Outcome Measure Information:
Title
Kujala knee outcome score
Description
A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms
Time Frame
Between two and five years after surgery
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee subjective outcome score
Description
A validated international outcome score that evaluates general knee functional outcome
Time Frame
Between two and five years after surgery
Title
Tenger activity level score
Description
A validated international outcome score that evaluates highest level of sports activity
Time Frame
Between two and five years after surgery
Title
Marx activity level score
Description
A validated international outcome score that evaluates highest level of sports activity
Time Frame
Between two and five years after surgery
Title
Visual Analogue Scale
Description
A validated international scale that evaluates level of pain
Time Frame
Between two and five years after surgery
Title
Single hop test
Description
Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance
Time Frame
Between two and five years after surgery
Title
Side-to-side hop test
Description
Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds
Time Frame
Between two and five years after surgery
Title
Patellar apprehension test
Description
Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly
Time Frame
Between two and five years after surgery
Title
Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage
Description
Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage
Time Frame
Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IFTACH HETSRONI, M.D.
Phone
972-9-747
Ext
1182
Email
iftach.hetsroni@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
DROR LINDNER, M.D.
Phone
972-8-977
Ext
9443
Email
Drorlindner@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IFTACH HETSRONI, M.D.
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DROR LINDNER, M.D.
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
IDAN ILSAR, M.D.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MAZEN FALAH, M.D.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NASSIM ALKRINAWI, M.D.
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iftach Hetsroni, M.D.
Phone
972-9-7471182
Email
iftach.hetsroni@clalit.org.il

12. IPD Sharing Statement

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

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