Clinical trial NCT02480959: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Patella, Familial Recurrent Dislocation Of
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
name: Hadassah Medical Organization
name: Assaf-Harofeh Medical Center
name: Soroka University Medical Center
First posted: 2015-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Kujala knee outcome score
timeFrame: Between two and five years after surgery
Secondary outcomes:
measure: International Knee Documentation Committee subjective outcome score
timeFrame: Between two and five years after surgery
measure: Tenger activity level score
timeFrame: Between two and five years after surgery
measure: Marx activity level score
timeFrame: Between two and five years after surgery
measure: Visual Analogue Scale
timeFrame: Between two and five years after surgery
measure: Single hop test
timeFrame: Between two and five years after surgery
measure: Side-to-side hop test
timeFrame: Between two and five years after surgery
measure: Patellar apprehension test
timeFrame: Between two and five years after surgery
measure: Infectious event of the operated knee documented by number of events that required antibiotics treatment with or without joint lavage
timeFrame: Immediately after surgery, for the duration of hospital stay, and until expected time of 1 month
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: IFTACH HETSRONI, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh Medical Center
name: DROR LINDNER, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: IDAN ILSAR, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: MAZEN FALAH, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: NASSIM ALKRINAWI, M.D.
role: PRINCIPAL_INVESTIGATOR
References: