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

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

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.

Study Overview

• Status: Unknown
• Conditions: Patella, Familial Recurrent Dislocation Of
• Intervention / Treatment: Procedure: Surgical treatment for 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Recruiting
    • Meir Medical Center
    • Contact: Iftach Hetsroni, M.D.; Phone Number: 972-9-7471182; Email: iftach.hetsroni@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Medial plication; Patient undergoing surgical treatment for recurrent patellar instability that includes medial retinacular plication	Procedure: Surgical treatment for recurrent patellar instability; Either medial plication or MPFL reconstructuion surgery
Other: MPFL reconstruction; Patient undergoing surgical treatment for recurrent patellar instability that includes medial patellofemoral ligament reconstruction using a tendon graft	Procedure: Surgical treatment for recurrent patellar instability; Either medial plication or MPFL reconstructuion surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kujala knee outcome score	A validated international outcome score that evaluates knee functional outcome in relation to patellofemoral symptoms	Between two and five years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee subjective outcome score	A validated international outcome score that evaluates general knee functional outcome	Between two and five years after surgery
Tenger activity level score	A validated international outcome score that evaluates highest level of sports activity	Between two and five years after surgery
Marx activity level score	A validated international outcome score that evaluates highest level of sports activity	Between two and five years after surgery
Visual Analogue Scale	A validated international scale that evaluates level of pain	Between two and five years after surgery
Single hop test	Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance	Between two and five years after surgery
Side-to-side hop test	Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds	Between two and five years after surgery
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	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	Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage	Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: Rambam Health Care Campus; Hadassah Medical Organization; Assaf-Harofeh Medical Center; Soroka University Medical Center
• Investigators: Principal Investigator: IFTACH HETSRONI, M.D., Meir Medical Center; Principal Investigator: DROR LINDNER, M.D., Assaf-Harofeh Medical Center; Principal Investigator: IDAN ILSAR, M.D., Hadassah Medical Organization; Principal Investigator: MAZEN FALAH, M.D., Rambam Health Care Campus; Principal Investigator: NASSIM ALKRINAWI, M.D., Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 0041-15-MMC