Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability (MPFL)
Primary Purpose
Patellar Dislocation
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Reconstruction of MPFL with or without tibial tuberositas osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Dislocation focused on measuring Medial patello femoral ligament, Patellar instability, Reconstruction, Predicting factors
Eligibility Criteria
Inclusion Criteria:
- patients over 18 years of age
- surgical intervention with MPFL reconstruction
- with or without tibial tuberosity transposition (TTT).
Exclusion Criteria:
- trochleoplasty,
- corrective knee osteotomy
- reparative cartilage treatment
- reconstruction of other knee ligaments
- meniscus repair
- movement impairments
- plegia
- paresis
- neuromuscular diseases
- participation rejection
- rejection to complete the control questionnaires
- lack of understanding of the Slovenian language
Sites / Locations
- Department of Orthopaedic Surgery of the Ljubljana University Medical Centre
Outcomes
Primary Outcome Measures
Change of subjective knee status evaluated with EQ-5D
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with EQ-5D (European quality of life in 5 dimensions; min 0, max 100). Higher scores on the questioner mean a better outcome.
Change of subjective knee status evaluated with KOOS
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with KOOS (Knee osteoarthritis outcome score; min 0, max 100). Higher scores on the questioner mean a better outcome.
Change of subjective knee status on Tegner activity scale
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Tegner activity scale (min 0, max 10). Higher scores on the scale mean a better outcome.
Change of subjective knee status evaluated with Kujala score
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Kujala questioner (min 0, max100). Higher score means a better outcome.
Change of subjective knee status on IKDC
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be assessed with IKDC (International knee documentation committeemin; 0, max 100) questioner. Higher score on the questioner means a better outcome.
Secondary Outcome Measures
Patellar position change
The height of the patella in the late post-operative period is not expected to differ from its position immediately after the procedure. The patellar height will be assessed with Caton-Deschamp index on standard lateral X-rays before surgery, immediately after surgery and at least six months after surgery. Reference values for normal patellar height are 0.8 - 1.2.
Full Information
NCT ID
NCT04673188
First Posted
December 1, 2020
Last Updated
December 12, 2020
Sponsor
Nik Žlak
Collaborators
University of Ljubljana, Faculty of Medicine, University of Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT04673188
Brief Title
Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
Acronym
MPFL
Official Title
Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nik Žlak
Collaborators
University of Ljubljana, Faculty of Medicine, University of Ljubljana
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
The purpose of the study is:
to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity
to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of MPFL graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation
Keywords
Medial patello femoral ligament, Patellar instability, Reconstruction, Predicting factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Reconstruction of MPFL with or without tibial tuberositas osteotomy
Intervention Description
Reconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities.
Primary Outcome Measure Information:
Title
Change of subjective knee status evaluated with EQ-5D
Description
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with EQ-5D (European quality of life in 5 dimensions; min 0, max 100). Higher scores on the questioner mean a better outcome.
Time Frame
2-8 years
Title
Change of subjective knee status evaluated with KOOS
Description
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with KOOS (Knee osteoarthritis outcome score; min 0, max 100). Higher scores on the questioner mean a better outcome.
Time Frame
2-8 years
Title
Change of subjective knee status on Tegner activity scale
Description
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Tegner activity scale (min 0, max 10). Higher scores on the scale mean a better outcome.
Time Frame
2-8 years
Title
Change of subjective knee status evaluated with Kujala score
Description
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Kujala questioner (min 0, max100). Higher score means a better outcome.
Time Frame
2-8 years
Title
Change of subjective knee status on IKDC
Description
It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be assessed with IKDC (International knee documentation committeemin; 0, max 100) questioner. Higher score on the questioner means a better outcome.
Time Frame
2-8 years
Secondary Outcome Measure Information:
Title
Patellar position change
Description
The height of the patella in the late post-operative period is not expected to differ from its position immediately after the procedure. The patellar height will be assessed with Caton-Deschamp index on standard lateral X-rays before surgery, immediately after surgery and at least six months after surgery. Reference values for normal patellar height are 0.8 - 1.2.
Time Frame
2-8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 years of age
surgical intervention with MPFL reconstruction
with or without tibial tuberosity transposition (TTT).
Exclusion Criteria:
trochleoplasty,
corrective knee osteotomy
reparative cartilage treatment
reconstruction of other knee ligaments
meniscus repair
movement impairments
plegia
paresis
neuromuscular diseases
participation rejection
rejection to complete the control questionnaires
lack of understanding of the Slovenian language
Facility Information:
Facility Name
Department of Orthopaedic Surgery of the Ljubljana University Medical Centre
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
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