NCT05488275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

3.9 years

First QC Date

July 18, 2020

Last Update Submit

August 11, 2022

Conditions

Recurrent Patella Dislocation

Keywords

MPFLCampbell

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (27)

  • Functional tests

    12 weeks

  • Functional tests

    6 months

  • Functional tests

    12 months

  • Functional tests

    24 months

  • Knee Injury and Osteoarthritis Outcome Score

    12 weeks,

  • +22 more secondary outcomes

Study Arms (3)

MPFL static

ACTIVE COMPARATOR

Medial Patellofemoral Ligament reconstruction with hamstring graft - static procedure

Procedure: Surgery

Campbell

ACTIVE COMPARATOR

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

Procedure: Surgery

MPFL dynamic

ACTIVE COMPARATOR

Medial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure

Procedure: Surgery

Interventions

SurgeryPROCEDURE

MPFL reconstruction

CampbellMPFL dynamicMPFL static

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Otwock, Masovian Voivodeship, 05-400, Poland

RECRUITING

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Officials

  • Rafał Kamiński

    PCME, Otwock, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafał Kamiński

CONTACT

+48227794031rkaminski@spskgruca.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Head of Knee Surgery Division and Arthroscopy, Department of Trauma Surgery and Orthopedics

Study Record Dates

First Submitted

July 18, 2020

First Posted

August 4, 2022

Study Start

July 15, 2020

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

PL(1)