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MPFL vs Campbell in Recurrent Patella Dislocation

Not Applicable
Conditions
Recurrent Patella Dislocation
Interventions
Procedure: Surgery
Registration Number
NCT05488275
Lead Sponsor
Centre of Postgraduate Medical Education
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
90
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MPFL staticSurgeryMedial Patellofemoral Ligament reconstruction with hamstring graft - static procedure
CampbellSurgeryMedial Patellofemoral Ligament reconstruction using non-anatomic reconstruction (quadriceps femoris plasty - Campbell method)
MPFL dynamicSurgeryMedial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure
Primary Outcome Measures
NameTimeMethod
Imaging modality X-ray2 years

Patellofemoral Joints Biomechanics improvement measured by Q angle

Imaging modality CT2 years

Patellofemoral Joints Biomechanics improvement measured by TT-TG (line between tibial tuberosity and trochlear groove)

Secondary Outcome Measures
NameTimeMethod
Knee Injury and Osteoarthritis Outcome Score24 months

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).

Functional tests24 months

hop-for-distance

Pain Visual Analog Scale24 months

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).

Knee Injury and Osteoarthritis Outcome Score Patellofemoral24 months

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

The Victorian Institute of Sport Assessment24 months

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

International Knee Documentation Committee24 months

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.

Tegner Lysholm Knee Scoring Scale12 months

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).

Pain Visual Analog Scale.12 months,

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).

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital

🇵🇱

Otwock, Mazowieckie, Poland

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