Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability (MPFL)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Patellar Dislocation
• Intervention / Treatment: Procedure: Reconstruction of MPFL with or without tibial tuberositas osteotomy

• Study Type: Interventional
• Enrollment (Anticipated): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Department of Orthopaedic Surgery of the Ljubljana University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nik Žlak
• Collaborators: University of Ljubljana; University of Ljubljana, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Reconstruction; Patellar instability; Medial patello femoral ligament; Predicting factors
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: KME 0120-169/2020/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No