MPFL vs Campbell in Recurrent Patella Dislocation

Study Overview
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Brief Summary
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This study will compare anatomic Medial Patellofemoral Reconstruction from Hamstring graft with non anatomic reconstruction according to Campbell. The purpose of this study is to evaluate which type of treatment recurrent patella dislocation provides to better clinical, radiological and laboratory outcomes.

Detailed Description
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Recurrent patella dislocation require surgery treatment. It provides to less cartilage degeneration and slow down knee osteoarthritis. Medial retinacular complex is injured in first time patella dislocation and its reconstruction is necessary. In literature there can be found many surgical reconstruction technics: anatomical or non anatomical (functional). But there is lack of evidence which technic provides to better outcomes - reduce the possibility to patella dislocation and progression of osteoarthritis in patellofemoral joint. Nowadays the choice of performed surgery depends on surgeons personal assessment.

Official Title
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Prospective, Randomized, Double Blinded Trial Comparing Medial Patellofemoral Ligament Reconstruction (Hamstrings) Versus Campbell Functional Reconstruction (Non-anatomic) in Recurrent Patella Dislocation

Conditions
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Recurrent Patella Dislocation

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent patella dislocation No patellofemoral joint dysplasia or Dysplasia A/B according to Dejour (non operating) Acceptable is to perform concomitant medialization Tibial Tubercle Osteotomy Exclusion Criteria: no informed consent to participate in the study age under 18 years or above 65 multiligament injury or single plane knee instability another musculoskeletal disorders in lower limb lower limb deformity requiring axis correction: valgus femoral anteversion (CT measurements) joints inflammatory diseases concomitant patellectomy or trochleoplasty ASA score > II

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MPFL static<br>Medial Patellofemoral Ligament reconstruction with hamstring graft - static procedure | Procedure: Surgery<br>* MPFL reconstruction<br>|
| Active Comparator: Campbell<br>Medial Patellofemoral Ligament reconstruction using non-anatomic reconstruction (quadriceps femoris plasty - Campbell method) | Procedure: Surgery<br>* MPFL reconstruction<br>|
| Active Comparator: MPFL dynamic<br>Medial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure | Procedure: Surgery<br>* MPFL reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging modality X-ray | Patellofemoral Joints Biomechanics improvement measured by patella tilt | 1 year | 
| Imaging modality X-ray | Patellofemoral Joints Biomechanics improvement measured by Q angle | 2 years | 
| Imaging modality CT | Patellofemoral Joints Biomechanics improvement measured by Insall-Salvati ratio. The Insall-Salvati ratio or index is the ratio of the patella tendon length to the length of the patella and is used to determine patellar height. he Insall-Salvati ratio was initially determined on a 30° flexed lateral knee x-ray and was later applied to sagittal MRI. Distance lines are used to calculate Insall-Salvati ratio: A: patellar tendon length (TL): length of the posterior surface of the tendon from the lower pole of the patella to its insertion on the tibia B: patellar length (PL): greatest pole-to-pole length Insall-Salvati ratio = A/B (or TL/PL). patella baja: <0.8 normal: 0.8-1.2 patella alta: >1.2 | 2 years | 
| Imaging modality CT | Patellofemoral Joints Biomechanics improvement measured by TT-TG (line between tibial tuberosity and trochlear groove) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional tests | hop-for-distance | 12 weeks | 
| Functional tests | hop-for-distance | 6 months | 
| Functional tests | hop-for-distance | 12 months | 
| Functional tests | hop-for-distance | 24 months | 
| Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score; The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 12 weeks, | 
| Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score;The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 6 months, | 
| Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score; The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 12 months | 
| Knee Injury and Osteoarthritis Outcome Score | Knee Injury and Osteoarthritis Outcome Score;The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). | 24 months | 
| International Knee Documentation Committee | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function. | 12 weeks | 
| International Knee Documentation Committee | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function. | 6 months | 
| International Knee Documentation Committee | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function. | 12 months | 
| International Knee Documentation Committee | IKDC is subjective scale that provides patients with an overall function score. Total to a scaled number ranges from 0 to 100. higher number representing higher levels of function. | 24 months | 
| Tegner Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). | 12 weeks, | 
| Tegner Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). | 6 months, | 
| Tegner Lysholm Knee Scoring Scale | The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). | 12 months | 
| Pain Visual Analog Scale | The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 12 weeks, | 
| Pain Visual Analog Scale | The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 6 months, | 
| Pain Visual Analog Scale. | The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 12 months, | 
| Pain Visual Analog Scale | The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)[8] orientated from the left (worst) to the right (best). | 24 months | 
| Knee Injury and Osteoarthritis Outcome Score Patellofemoral | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 12 weeks | 
| Knee Injury and Osteoarthritis Outcome Score Patellofemoral | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 6 months, | 
| Knee Injury and Osteoarthritis Outcome Score Patellofemoral | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 12 months | 
| Knee Injury and Osteoarthritis Outcome Score Patellofemoral | the 'Knee Injury and Osteoarthritis Outcome Score Patellofemoral' questionnaire (KOOS-PF) is frequently used to measure symptoms and function among the people with PFJ-OA. This scale is scored from 0 to 100, with 100 representing no disability and 0 representing maximum disability | 24 months | 
| The Victorian Institute of Sport Assessment | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic | 12 weeks, | 
| The Victorian Institute of Sport Assessment | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic | 6 months, | 
| The Victorian Institute of Sport Assessment | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic | 12 months, | 
| The Victorian Institute of Sport Assessment | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. minimum 0, maximum 100 for asymptomatic | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Campbell, MPFL