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

Patella, Familial Recurrent Dislocation Of Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02480959
• Other study ID #: 0041-15-MMC
• Status: Recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Meir Medical Center
• Contact: IFTACH HETSRONI, M.D.
• Phone: 972-9-747
• Email: iftach.hetsroni[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Patella, Familial Recurrent Dislocation Of

Intervention

Procedure:
• Surgical treatment for recurrent patellar instability
Either medial plication or MPFL reconstructuion surgery

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (5)

Lead Sponsor	Collaborator
Meir Medical Center	Assaf-Harofeh Medical Center, Hadassah Medical Organization, Rambam Health Care Campus, Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Tenger activity level score	A validated international outcome score that evaluates highest level of sports activity	Between two and five years after surgery
Secondary	Marx activity level score	A validated international outcome score that evaluates highest level of sports activity	Between two and five years after surgery
Secondary	Visual Analogue Scale	A validated international scale that evaluates level of pain	Between two and five years after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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