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Clinical Trials/NCT04673188
NCT04673188
Enrolling By Invitation
Not Applicable

Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

Nik Žlak1 site in 1 country145 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellar Dislocation
Sponsor
Nik Žlak
Enrollment
145
Locations
1
Primary Endpoint
Change of subjective knee status evaluated with EQ-5D
Status
Enrolling By Invitation
Last Updated
5 years ago

Overview

Brief Summary

The purpose of the study is:

  1. 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
  2. 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.
Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
September 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Nik Žlak
Responsible Party
Sponsor Investigator
Principal Investigator

Nik Žlak

Principal investigator, Doctor of medicine, PhD student

University Medical Centre Ljubljana

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
  • neuromuscular diseases
  • participation rejection
  • rejection to complete the control questionnaires
  • lack of understanding of the Slovenian language

Outcomes

Primary Outcomes

Change of subjective knee status evaluated with EQ-5D

Time Frame: 2-8 years

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

Time Frame: 2-8 years

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

Time Frame: 2-8 years

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

Time Frame: 2-8 years

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

Time Frame: 2-8 years

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 Outcomes

  • Patellar position change(2-8 years)

Study Sites (1)

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