Clinical trial NCT05488275: MPFL vs Campbell in Recurrent Patella Dislocation
Official title: Prospective, Randomized, Double Blinded Trial Comparing Medial Patellofemoral Ligament Reconstruction (Hamstrings) Versus Campbell Functional Reconstruction (Non-anatomic) in Recurrent Patella Dislocation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Patella Dislocation
Keywords: MPFL
Campbell
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Imaging modality X-ray
timeFrame: 1 year
measure: Imaging modality X-ray
timeFrame: 2 years
measure: Imaging modality CT
timeFrame: 2 years
measure: Imaging modality CT
timeFrame: 2 years
Secondary outcomes:
measure: Functional tests
timeFrame: 12 weeks
measure: Functional tests
timeFrame: 6 months
measure: Functional tests
timeFrame: 12 months
measure: Functional tests
timeFrame: 24 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 12 weeks,
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 months,
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 12 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 24 months
measure: International Knee Documentation Committee
timeFrame: 12 weeks
measure: International Knee Documentation Committee
timeFrame: 6 months
measure: International Knee Documentation Committee
timeFrame: 12 months
measure: International Knee Documentation Committee
timeFrame: 24 months
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 12 weeks,
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 6 months,
measure: Tegner Lysholm Knee Scoring Scale
timeFrame: 12 months
measure: Pain Visual Analog Scale
timeFrame: 12 weeks,
measure: Pain Visual Analog Scale
timeFrame: 6 months,
measure: Pain Visual Analog Scale.
timeFrame: 12 months,
measure: Pain Visual Analog Scale
timeFrame: 24 months
measure: Knee Injury and Osteoarthritis Outcome Score Patellofemoral
timeFrame: 12 weeks
measure: Knee Injury and Osteoarthritis Outcome Score Patellofemoral
timeFrame: 6 months,
measure: Knee Injury and Osteoarthritis Outcome Score Patellofemoral
timeFrame: 12 months
measure: Knee Injury and Osteoarthritis Outcome Score Patellofemoral
timeFrame: 24 months
measure: The Victorian Institute of Sport Assessment
timeFrame: 12 weeks,
measure: The Victorian Institute of Sport Assessment
timeFrame: 6 months,
measure: The Victorian Institute of Sport Assessment
timeFrame: 12 months,
measure: The Victorian Institute of Sport Assessment
timeFrame: 24 months
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
state: Mazowieckie
Study officials:
affiliation: PCME, Otwock, Poland
name: Rafał Kamiński
role: PRINCIPAL_INVESTIGATOR
References: