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MPFL vs Campbell in Recurrent Patella Dislocation

Primary Purpose

Recurrent Patella Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Surgery
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Recurrent Patella Dislocation focused on measuring MPFL, Campbell

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

MPFL static

Campbell

MPFL dynamic

Arm Description

Medial Patellofemoral Ligament reconstruction with hamstring graft - static procedure

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

Medial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure

Outcomes

Primary Outcome Measures

Imaging modality X-ray
Patellofemoral Joints Biomechanics improvement measured by patella tilt
Imaging modality X-ray
Patellofemoral Joints Biomechanics improvement measured by Q angle
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
Imaging modality CT
Patellofemoral Joints Biomechanics improvement measured by TT-TG (line between tibial tuberosity and trochlear groove)

Secondary Outcome Measures

Functional tests
hop-for-distance
Functional tests
hop-for-distance
Functional tests
hop-for-distance
Functional tests
hop-for-distance
Knee Injury and Osteoarthritis Outcome Score
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).
Knee Injury and Osteoarthritis Outcome Score
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).
Knee Injury and Osteoarthritis Outcome Score
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).
Knee Injury and Osteoarthritis Outcome Score
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).
International Knee Documentation Committee
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.
International Knee Documentation Committee
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.
International Knee Documentation Committee
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.
International Knee Documentation Committee
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 Scale
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).
Tegner Lysholm Knee Scoring Scale
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).
Tegner Lysholm Knee Scoring Scale
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
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).
Pain Visual Analog Scale
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).
Pain Visual Analog Scale.
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).
Pain Visual Analog Scale
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 Patellofemoral
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
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
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
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
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
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
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 Assessment
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
The Victorian Institute of Sport Assessment
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
The Victorian Institute of Sport Assessment
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
The Victorian Institute of Sport Assessment
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

Full Information

First Posted
July 18, 2020
Last Updated
August 11, 2022
Sponsor
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT05488275
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Patella Dislocation
Keywords
MPFL, Campbell

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MPFL static
Arm Type
Active Comparator
Arm Description
Medial Patellofemoral Ligament reconstruction with hamstring graft - static procedure
Arm Title
Campbell
Arm Type
Active Comparator
Arm Description
Medial Patellofemoral Ligament reconstruction using non-anatomic reconstruction (quadriceps femoris plasty - Campbell method)
Arm Title
MPFL dynamic
Arm Type
Active Comparator
Arm Description
Medial Patellofemoral Ligament reconstruction with hamstring graft - dynamic procedure
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
MPFL reconstruction
Primary Outcome Measure Information:
Title
Imaging modality X-ray
Description
Patellofemoral Joints Biomechanics improvement measured by patella tilt
Time Frame
1 year
Title
Imaging modality X-ray
Description
Patellofemoral Joints Biomechanics improvement measured by Q angle
Time Frame
2 years
Title
Imaging modality CT
Description
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
Time Frame
2 years
Title
Imaging modality CT
Description
Patellofemoral Joints Biomechanics improvement measured by TT-TG (line between tibial tuberosity and trochlear groove)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Functional tests
Description
hop-for-distance
Time Frame
12 weeks
Title
Functional tests
Description
hop-for-distance
Time Frame
6 months
Title
Functional tests
Description
hop-for-distance
Time Frame
12 months
Title
Functional tests
Description
hop-for-distance
Time Frame
24 months
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
12 weeks,
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
6 months,
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
12 months
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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).
Time Frame
24 months
Title
International Knee Documentation Committee
Description
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.
Time Frame
12 weeks
Title
International Knee Documentation Committee
Description
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.
Time Frame
6 months
Title
International Knee Documentation Committee
Description
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.
Time Frame
12 months
Title
International Knee Documentation Committee
Description
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.
Time Frame
24 months
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
12 weeks,
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
6 months,
Title
Tegner Lysholm Knee Scoring Scale
Description
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).
Time Frame
12 months
Title
Pain Visual Analog Scale
Description
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).
Time Frame
12 weeks,
Title
Pain Visual Analog Scale
Description
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).
Time Frame
6 months,
Title
Pain Visual Analog Scale.
Description
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).
Time Frame
12 months,
Title
Pain Visual Analog Scale
Description
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).
Time Frame
24 months
Title
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Description
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
Time Frame
12 weeks
Title
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Description
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
Time Frame
6 months,
Title
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Description
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
Time Frame
12 months
Title
Knee Injury and Osteoarthritis Outcome Score Patellofemoral
Description
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
Time Frame
24 months
Title
The Victorian Institute of Sport Assessment
Description
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
Time Frame
12 weeks,
Title
The Victorian Institute of Sport Assessment
Description
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
Time Frame
6 months,
Title
The Victorian Institute of Sport Assessment
Description
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
Time Frame
12 months,
Title
The Victorian Institute of Sport Assessment
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafał Kamiński
Phone
+48227794031
Ext
469
Email
rkaminski@spskgruca.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafał Kamiński
Organizational Affiliation
PCME, Otwock, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal Kaminski, MD PhD
Phone
+48227794031
Ext
469
Email
rkaminski@spskgruca.pl
First Name & Middle Initial & Last Name & Degree
Stanislaw Pomianowski, MD PhD Prof
Phone
+48227794031
Ext
481
Email
spom@spskgruca.pl

12. IPD Sharing Statement

Learn more about this trial

MPFL vs Campbell in Recurrent Patella Dislocation

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