Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

Study Overview
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Brief Summary
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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.

Official Title
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Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

Conditions
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Patellar Dislocation

Intervention / Treatment
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* Procedure: Reconstruction of MPFL with or without tibial tuberositas osteotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Reconstruction of MPFL with or without tibial tuberositas osteotomy|Reconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2-8 years | 
| 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. | 2-8 years | 
| 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. | 2-8 years | 
| 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. | 2-8 years | 
| 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. | 2-8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2-8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medial patello femoral ligament, Patellar instability, Reconstruction, Predicting factors