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Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial
BACKGROUND: An incision for total hip arthroplasty (THA) via the direct anterior approach (DAA) is generally made outside of the space between the sartorius and tensor fasciae latae muscles to prevent lateral femoral cutaneous nerve (LFCN) injury. Anatomical studies have revealed that the LFCN cours...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9287917/ https://www.ncbi.nlm.nih.gov/pubmed/35841003 http://dx.doi.org/10.1186/s13063-022-06496-2 |
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author | Tanabe, Hiroki Baba, Tomonori Ozaki, Yu Yanagisawa, Naotake Banno, Sammy Watari, Taiji Homma, Yasuhiro Nagao, Masashi Kaneko, Kazuo Ishijima, Muneaki |
author_facet | Tanabe, Hiroki Baba, Tomonori Ozaki, Yu Yanagisawa, Naotake Banno, Sammy Watari, Taiji Homma, Yasuhiro Nagao, Masashi Kaneko, Kazuo Ishijima, Muneaki |
author_sort | Tanabe, Hiroki |
collection | PubMed |
description | BACKGROUND: An incision for total hip arthroplasty (THA) via the direct anterior approach (DAA) is generally made outside of the space between the sartorius and tensor fasciae latae muscles to prevent lateral femoral cutaneous nerve (LFCN) injury. Anatomical studies have revealed that the LFCN courses between the sartorius and tensor fasciae latae muscles. When the LFCN branches radially while distributing in the transverse direction from the sartorius muscle to the tensor fasciae latae muscle, it is called the fan type. Studies suggest that damage to the fan type LFCN is unavoidable during conventional fasciotomy. We previously demonstrated that injury to non-fan variation LFCN occurred in 28.6% of patients who underwent THA by fasciotomy performed 2 cm away from the intermuscular space. This suggests that the conventional approach also poses a risk of LFCN injury to non-fan variation LFCN. LFCN injury is rarely reported in the anterolateral approach, which involves incision of fascia further away than the DAA. The purpose of this study is to investigate how the position of fasciotomy in DAA affects the risk of LFCN injury. METHODS: We will conduct a prospective, randomized, controlled study. All patients will be divided into a fan variation and a non-fan variation group using ultrasonography before surgery. Patients with non-fan variation LFCN will receive conventional fasciotomy and lateral fasciotomy in the order specified in the allocation table created in advance by our clinical trial center. The primary endpoint will be the presence of LFCN injury during an outpatient visit using a patient-based questionnaire. The secondary endpoints will be assessed based on patient-reported outcomes at 3 months after surgery in an outpatient setting using the Western Ontario and McMaster Universities Osteoarthritis Index, the Japanese Orthopaedic Association Hip-disease Evaluation Questionnaire, and the Forgotten-Joint Score-12. DISCUSSION: We hypothesize that the incidence of LFCN injury due to DAA-THA is reduced by making the incision further away from where it is typically made in conventional fasciotomy. If our hypothesis is confirmed, it will reduce the disadvantages of DAA and improve patient satisfaction. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000035945. Registered on 20 February, 2019. |
format | Online Article Text |
id | pubmed-9287917 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-92879172022-07-17 Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial Tanabe, Hiroki Baba, Tomonori Ozaki, Yu Yanagisawa, Naotake Banno, Sammy Watari, Taiji Homma, Yasuhiro Nagao, Masashi Kaneko, Kazuo Ishijima, Muneaki Trials Study Protocol BACKGROUND: An incision for total hip arthroplasty (THA) via the direct anterior approach (DAA) is generally made outside of the space between the sartorius and tensor fasciae latae muscles to prevent lateral femoral cutaneous nerve (LFCN) injury. Anatomical studies have revealed that the LFCN courses between the sartorius and tensor fasciae latae muscles. When the LFCN branches radially while distributing in the transverse direction from the sartorius muscle to the tensor fasciae latae muscle, it is called the fan type. Studies suggest that damage to the fan type LFCN is unavoidable during conventional fasciotomy. We previously demonstrated that injury to non-fan variation LFCN occurred in 28.6% of patients who underwent THA by fasciotomy performed 2 cm away from the intermuscular space. This suggests that the conventional approach also poses a risk of LFCN injury to non-fan variation LFCN. LFCN injury is rarely reported in the anterolateral approach, which involves incision of fascia further away than the DAA. The purpose of this study is to investigate how the position of fasciotomy in DAA affects the risk of LFCN injury. METHODS: We will conduct a prospective, randomized, controlled study. All patients will be divided into a fan variation and a non-fan variation group using ultrasonography before surgery. Patients with non-fan variation LFCN will receive conventional fasciotomy and lateral fasciotomy in the order specified in the allocation table created in advance by our clinical trial center. The primary endpoint will be the presence of LFCN injury during an outpatient visit using a patient-based questionnaire. The secondary endpoints will be assessed based on patient-reported outcomes at 3 months after surgery in an outpatient setting using the Western Ontario and McMaster Universities Osteoarthritis Index, the Japanese Orthopaedic Association Hip-disease Evaluation Questionnaire, and the Forgotten-Joint Score-12. DISCUSSION: We hypothesize that the incidence of LFCN injury due to DAA-THA is reduced by making the incision further away from where it is typically made in conventional fasciotomy. If our hypothesis is confirmed, it will reduce the disadvantages of DAA and improve patient satisfaction. TRIAL REGISTRATION: UMIN Clinical Trials Registry, UMIN000035945. Registered on 20 February, 2019. BioMed Central 2022-07-15 /pmc/articles/PMC9287917/ /pubmed/35841003 http://dx.doi.org/10.1186/s13063-022-06496-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Tanabe, Hiroki Baba, Tomonori Ozaki, Yu Yanagisawa, Naotake Banno, Sammy Watari, Taiji Homma, Yasuhiro Nagao, Masashi Kaneko, Kazuo Ishijima, Muneaki Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
title | Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
title_full | Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
title_fullStr | Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
title_full_unstemmed | Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
title_short | Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
title_sort | lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9287917/ https://www.ncbi.nlm.nih.gov/pubmed/35841003 http://dx.doi.org/10.1186/s13063-022-06496-2 |
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