Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

NCT ID: NCT04673188

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Patellar Dislocation

Keywords

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Medial patello femoral ligament Patellar instability Reconstruction Predicting factors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role collaborator

University of Ljubljana

OTHER

Sponsor Role collaborator

Nik Žlak

OTHER

Sponsor Role lead

Responsible Party

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Nik Žlak

Principal investigator, Doctor of medicine, PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Orthopaedic Surgery of the Ljubljana University Medical Centre

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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KME 0120-169/2020/4

Identifier Type: -

Identifier Source: org_study_id