MPFL vs Campbell in Recurrent Patella Dislocation

NCT ID: NCT05488275

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2024-05-30

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.

Conditions

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Recurrent Patella Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MPFL static

Medial Patellofemoral Ligament reconstruction with hamstring graft - static procedure

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

MPFL reconstruction

Campbell

Medial Patellofemoral Ligament reconstruction using non-anatomic reconstruction (quadriceps femoris plasty - Campbell method)

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

MPFL reconstruction

MPFL dynamic

Medial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

MPFL reconstruction

Interventions

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Surgery

MPFL reconstruction

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role lead

Responsible Party

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Rafał Kamiński

Clinical Professor, Head of Knee Surgery Division and Arthroscopy, Department of Trauma Surgery and Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafał Kamiński

Role: PRINCIPAL_INVESTIGATOR

PCME, Otwock, Poland

Locations

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

Otwock, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Rafał Kamiński

Role: CONTACT

+48227794031 ext. 469

Facility Contacts

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Rafal Kaminski, MD PhD

Role: primary

+48227794031 ext. 469

Stanislaw Pomianowski, MD PhD Prof

Role: backup

+48227794031 ext. 481

Other Identifiers

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mpfl_campbell

Identifier Type: -

Identifier Source: org_study_id

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