MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO

May 18, 2023 updated by: Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic

Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.

The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Konrad Malinowski, MD PhD
  • Phone Number: +48 509812212
  • Email: malwin8@wp.pl

Study Locations

  • Poland
    • Łódzkie
      • Bełchatów, Łódzkie, Poland, 97-400
        • Recruiting
        • Artromedical Orthopaedic Clinic
        • Contact:
          • Konrad Malinowski, MD PhD
          • Phone Number: +48 509 812 212
          • Email: malwin8@wp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Lateral patellar dislocation with subsequent instability
  • Failure of non-operative treatment

Exclusion Criteria:

  • Active inflammation of the knee;
  • Previous surgeries on the patellofemoral joint;
  • Fractures around the knee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main arm of the study
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy will be performed in these patients.
Procedure: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. Management of any accompanying patellofemoral lesions will be performed as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lateral patella stability - apprehension test
Time Frame: At the 12 month of the follow-up.
Apprehension test at 30 degrees of knee flexion
At the 12 month of the follow-up.
Lateral patella stability - lateral luxation test
Time Frame: At the 12 month of the follow-up.
Lateral luxation test at 30 degrees of knee flexion
At the 12 month of the follow-up.
Lateral patella stability - apprehension test
Time Frame: At the 24 month of the follow-up.
Apprehension test at 30 degrees of knee flexion
At the 24 month of the follow-up.
Lateral patella stability - lateral luxation test
Time Frame: At the 24 month of the follow-up.
Lateral luxation test at 30 degrees of knee flexion
At the 24 month of the follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time Frame: At the 12 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
At the 12 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time Frame: At the 24 month of the follow-up.
Min of 0 max of 87 points, higher scores mean a better outcome
At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time Frame: At the 12 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Time Frame: At the 24 month of the follow-up.
Min of 0 max of 100 points, higher scores mean a better outcome
At the 24 month of the follow-up.
ROM
Time Frame: At the 12 month of the follow-up.
Knee range of motion assessed by the means of goniometer.
At the 12 month of the follow-up.
ROM
Time Frame: At the 24 month of the follow-up.
Knee range of motion assessed by the means of goniometer.
At the 24 month of the follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artromedical Konrad Malinowski Clinic

Investigators

  • Principal Investigator: Konrad Malinowski, MD PhD, Artromedical Orthopaedic Clinic, Bełchatów, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-pro-ar-2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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