Skip to content

MPFL vs Campbell in Recurrent Patella Dislocation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05488275
Enrollment
90
Registered
2022-08-04
Start date
2020-07-15
Completion date
2024-05-30
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Patella Dislocation

Keywords

MPFL, Campbell

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.

Interventions

PROCEDURESurgery

MPFL reconstruction

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Imaging modality X-ray1 yearPatellofemoral Joints Biomechanics improvement measured by patella tilt
Imaging modality CT2 yearsPatellofemoral 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

Secondary

MeasureTime frameDescription
International Knee Documentation Committee12 weeksIKDC 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 weeks,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 Scale12 weeks,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).
Functional tests12 weekshop-for-distance
Knee Injury and Osteoarthritis Outcome Score Patellofemoral12 weeksthe '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 Assessment12 weeks,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
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).
Knee Injury and Osteoarthritis Outcome Score12 weeks,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).

Countries

Poland

Contacts

Primary ContactRafał Kamiński
rkaminski@spskgruca.pl+48227794031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026