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

Primary Purpose

Lateral Patellofemoral Dislocation Closed Traumatic, Lateral Patellar Luxation

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Sponsored by
Artromedical Konrad Malinowski Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Patellofemoral Dislocation Closed Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artromedical Orthopaedic ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main arm of the study

Arm Description

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.

Outcomes

Primary Outcome Measures

Lateral patella stability - apprehension test
Apprehension test at 30 degrees of knee flexion
Lateral patella stability - lateral luxation test
Lateral luxation test at 30 degrees of knee flexion
Lateral patella stability - apprehension test
Apprehension test at 30 degrees of knee flexion
Lateral patella stability - lateral luxation test
Lateral luxation test at 30 degrees of knee flexion

Secondary Outcome Measures

The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Min of 0 max of 87 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
ROM
Knee range of motion assessed by the means of goniometer.
ROM
Knee range of motion assessed by the means of goniometer.

Full Information

First Posted
May 8, 2023
Last Updated
May 18, 2023
Sponsor
Artromedical Konrad Malinowski Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05868434
Brief Title
MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO
Official Title
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artromedical Konrad Malinowski Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Patellofemoral Dislocation Closed Traumatic, Lateral Patellar Luxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main arm of the study
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lateral patella stability - apprehension test
Description
Apprehension test at 30 degrees of knee flexion
Time Frame
At the 12 month of the follow-up.
Title
Lateral patella stability - lateral luxation test
Description
Lateral luxation test at 30 degrees of knee flexion
Time Frame
At the 12 month of the follow-up.
Title
Lateral patella stability - apprehension test
Description
Apprehension test at 30 degrees of knee flexion
Time Frame
At the 24 month of the follow-up.
Title
Lateral patella stability - lateral luxation test
Description
Lateral luxation test at 30 degrees of knee flexion
Time Frame
At the 24 month of the follow-up.
Secondary Outcome Measure Information:
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.
Title
ROM
Description
Knee range of motion assessed by the means of goniometer.
Time Frame
At the 12 month of the follow-up.
Title
ROM
Description
Knee range of motion assessed by the means of goniometer.
Time Frame
At the 24 month of the follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Malinowski, MD PhD
Phone
+48 509812212
Email
malwin8@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Organizational Affiliation
Artromedical Orthopaedic Clinic, Bełchatów, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artromedical Orthopaedic Clinic
City
Bełchatów
State/Province
Łódzkie
ZIP/Postal Code
97-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Phone
+48 509 812 212
Email
malwin8@wp.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36804459
Citation
Ryan PC, Ross BJ, Stamm MA, Sherman WF, Heard WMR, Mulcahey MK. Concomitant Tibial Tubercle Osteotomy Reduces the Risk of Revision Surgery After Medial Patellofemoral Ligament Reconstruction for the Treatment of Patellar Instability. Arthroscopy. 2023 Sep;39(9):2037-2045.e1. doi: 10.1016/j.arthro.2023.02.006. Epub 2023 Feb 18.
Results Reference
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PubMed Identifier
31019984
Citation
Agarwalla A, Gowd AK, Liu JN, Puzzitiello RN, Yanke AB, Verma NN, Forsythe B. Concomitant Medial Patellofemoral Ligament Reconstruction and Tibial Tubercle Osteotomy Do Not Increase the Incidence of 30-Day Complications: An Analysis of the NSQIP Database. Orthop J Sports Med. 2019 Apr 12;7(4):2325967119837639. doi: 10.1177/2325967119837639. eCollection 2019 Apr.
Results Reference
background
PubMed Identifier
30612771
Citation
Franciozi CE, Ambra LF, Albertoni LJB, Debieux P, Granata GSM Jr, Kubota MS, Carneiro M, Abdalla RJ, Luzo MVM, Cohen M. Anteromedial Tibial Tubercle Osteotomy Improves Results of Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability in Patients With Tibial Tuberosity-Trochlear Groove Distance of 17 to 20 mm. Arthroscopy. 2019 Feb;35(2):566-574. doi: 10.1016/j.arthro.2018.10.109. Epub 2019 Jan 4.
Results Reference
background
PubMed Identifier
34692883
Citation
Aliberti GM, Kraeutler MJ, Miskimin C, Scillia AJ, Belk JW, Mulcahey MK. Autograft Versus Allograft for Medial Patellofemoral Ligament Reconstruction: A Systematic Review. Orthop J Sports Med. 2021 Oct 19;9(10):23259671211046639. doi: 10.1177/23259671211046639. eCollection 2021 Oct.
Results Reference
background
PubMed Identifier
29789255
Citation
Allen MM, Krych AJ, Johnson NR, Mohan R, Stuart MJ, Dahm DL. Combined Tibial Tubercle Osteotomy and Medial Patellofemoral Ligament Reconstruction for Recurrent Lateral Patellar Instability in Patients With Multiple Anatomic Risk Factors. Arthroscopy. 2018 Aug;34(8):2420-2426.e3. doi: 10.1016/j.arthro.2018.02.049. Epub 2018 May 19.
Results Reference
background
PubMed Identifier
28508959
Citation
Lobner S, Krauss C, Reichwein F, Patzer T, Nebelung W, Venjakob AJ. Surgical treatment of patellar instability: clinical and radiological outcome after medial patellofemoral ligament reconstruction and tibial tuberosity medialisation. Arch Orthop Trauma Surg. 2017 Aug;137(8):1087-1095. doi: 10.1007/s00402-017-2705-z. Epub 2017 May 16.
Results Reference
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MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO

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