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

NCT05868434 | Recruiting

• 1 other identifier: 3-pro-ar-2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Patellofemoral Dislocation Closed Traumatic; Lateral Patellar Luxation

Outcome Measures

Primary Outcomes (4)

• Lateral patella stability - apprehension test

  Apprehension test at 30 degrees of knee flexion

  At the 12 month of the follow-up.

• Lateral patella stability - lateral luxation test

  Lateral luxation test at 30 degrees of knee flexion

  At the 12 month of the follow-up.

• Lateral patella stability - apprehension test

  Apprehension test at 30 degrees of knee flexion

  At the 24 month of the follow-up.

• Lateral patella stability - lateral luxation test

  Lateral luxation test at 30 degrees of knee flexion

  At the 24 month of the follow-up.

Secondary Outcomes (6)

• The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

  At the 12 month of the follow-up.

• The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

  At the 24 month of the follow-up.

• The functional assessment with the Knee injury and Osteoarthritis Outcome Score

  At the 12 month of the follow-up.

• The functional assessment with the Knee injury and Osteoarthritis Outcome Score

  At the 24 month of the follow-up.

• ROM

  At the 12 month of the follow-up.

Study Arms (1)

Main arm of the study

EXPERIMENTAL

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.

Interventions

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

Main arm of the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Artromedical Konrad Malinowski Clinic: lead

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

RECRUITING

Related Publications (6)

• 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.

  PMID: 36804459 BACKGROUND

• 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.

  PMID: 31019984 BACKGROUND

• 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.

  PMID: 30612771 BACKGROUND

• 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.

  PMID: 34692883 BACKGROUND

• 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.

  PMID: 29789255 BACKGROUND

• 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.

  PMID: 28508959 BACKGROUND

Study Officials

• Konrad Malinowski, MD PhD

  Artromedical Orthopaedic Clinic, Bełchatów, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Malinowski, MD PhD

CONTACT

+48 509812212; malwin8@wp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 22, 2023
• Study Start: February 25, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

PL (1)