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

NCT ID: NCT05868434

Last Updated: 2023-05-22

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

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-25

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Lateral Patellofemoral Dislocation Closed Traumatic Lateral Patellar Luxation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Artromedical Konrad Malinowski Clinic

OTHER

Sponsor Role lead

Responsible Party

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Konrad Malinowski MD

Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Konrad Malinowski, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Artromedical Orthopaedic Clinic, Bełchatów, Poland

Locations

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Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Konrad Malinowski, MD PhD

Role: CONTACT

+48 509812212

Facility Contacts

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Konrad Malinowski, MD PhD

Role: primary

+48 509 812 212

References

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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.

Reference Type BACKGROUND
PMID: 36804459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31019984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30612771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34692883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29789255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28508959 (View on PubMed)

Other Identifiers

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3-pro-ar-2023

Identifier Type: -

Identifier Source: org_study_id

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