Clinical trial NCT05868434: 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
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Patellofemoral Dislocation Closed Traumatic
Lateral Patellar Luxation
Lead sponsor: Artromedical Konrad Malinowski Clinic
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lateral patella stability - apprehension test
timeFrame: At the 12 month of the follow-up.
measure: Lateral patella stability - lateral luxation test
timeFrame: At the 12 month of the follow-up.
measure: Lateral patella stability - apprehension test
timeFrame: At the 24 month of the follow-up.
measure: Lateral patella stability - lateral luxation test
timeFrame: At the 24 month of the follow-up.
Secondary outcomes:
measure: The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
timeFrame: At the 12 month of the follow-up.
measure: The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
timeFrame: At the 24 month of the follow-up.
measure: The functional assessment with the Knee injury and Osteoarthritis Outcome Score
timeFrame: At the 12 month of the follow-up.
measure: The functional assessment with the Knee injury and Osteoarthritis Outcome Score
timeFrame: At the 24 month of the follow-up.
measure: ROM
timeFrame: At the 12 month of the follow-up.
measure: ROM
timeFrame: At the 24 month of the follow-up.
Other outcomes:
Locations:
city: Bełchatów
country: Poland
facility: Artromedical Orthopaedic Clinic
state: Łódzkie
Study officials:
affiliation: Artromedical Orthopaedic Clinic, Bełchatów, Poland
name: Konrad Malinowski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.