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

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ClinicalTrials.gov Identifier: NCT02480959
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Patella, Familial Recurrent Dislocation Of 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. International Knee Documentation Committee subjective outcome score [ Time Frame: Between two and five years after surgery ]
    A validated international outcome score that evaluates general knee functional outcome

  2. Tenger activity level score [ Time Frame: Between two and five years after surgery ]
    A validated international outcome score that evaluates highest level of sports activity

  3. Marx activity level score [ Time Frame: Between two and five years after surgery ]
    A validated international outcome score that evaluates highest level of sports activity

  4. Visual Analogue Scale [ Time Frame: Between two and five years after surgery ]
    A validated international scale that evaluates level of pain

  5. Single hop test [ Time Frame: Between two and five years after surgery ]
    Evaluates limb asymmetry index between operated and nonoperated limbs during a single legged hop for distance

  6. Side-to-side hop test [ Time Frame: Between two and five years after surgery ]
    Evaluates limb asymmetry index between operated and nonoperated limbs performing side to side repetaed hops during 30 seconds

  7. Patellar apprehension test [ Time Frame: Between two and five years after surgery ]
    Evaluates normal patellar tracking and patient's feeling of subjective comfort while the examiner apply a provocative force that translates the patella lateraly

  8. Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage [ Time Frame: Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month ]
    Infection of the surgical site as a severe complication of surgery, requirng antibiotics with or without joint lavage


Eligibility Criteria

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480959


Contacts
Contact: IFTACH HETSRONI, M.D. 972-9-747 ext 1182 iftach.hetsroni@clalit.org.il
Contact: DROR LINDNER, M.D. 972-8-977 ext 9443 Drorlindner@gmail.com

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Iftach Hetsroni, M.D.    972-9-7471182    iftach.hetsroni@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
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 Center
Principal Investigator: MAZEN FALAH, M.D. Rambam Health Care Campus
Principal Investigator: NASSIM ALKRINAWI, M.D. Soroka Medical Center
More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02480959     History of Changes
Other Study ID Numbers: 0041-15-MMC
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: March 2016

Additional relevant MeSH terms:
Joint Dislocations
Joint Instability
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Joint Diseases