Biomechanical Evaluation With Finite Element Models in Thumb Carpometacarpal Osteoarthitis: Prospective Comparative Analysis of Loads in Arthroplasty With or Without Implants
調査の概要
状態
詳細な説明
For determine the normal kinematics of the thumb carpometacarpal (CMC) joint, Imaeda et al. (1994) examined in specimens four conditions which simulated normal function of the thumb: a) passive circumduction, b) active circumduction, c) static loading, and d) single-axis loading. Changes in normal kinematics predispose the CMC joint to osteoarthritis (OA). Previous studies used radiographic techniques that usually were static or measured the end range of motion.
For thumb CMC joint OA the prosthesis or total joint arthroplasty is one of the surgical option. Murai (2022) studied in ten healthy men with reconstruction 3D bone models the optimal center of rotation of the implant and found that the center of rotation change across various thumb positions. In the study by D´Agostino et al. (2018) a CT scan was used to quantify the 3D thumb kinematics in four female patients, before and after trapeziometacarpal joint replacement surgery with the Arpe implant. Thumb CMC joint OA led to a marked decrease of internal rotation and abduction of the first metacarpal during thumb flexion and a decrease of metacarpal adduction during thumb adduction. The abcense of first metacarpal translation in the ball-and-socket implant seems to indicate a decrease of first metacarpal adduction. Advanced thumb CMC joint OA mainly restrict the first metacarpal mobility. Whereas prosthesis is able to restore thumb function, it cannot fully replicate the kinematics of the healthy trapeziometacarpal joint.
This study will include 40 adults patients with chronic pain and carpometacarpal osteoarthritis that need surgical intervention. For the biomechanical evaluation, 3D modeling and finite element methods of evaluation of the CT scan before and after the surgical intervention in each patient will be performed with the computed specific software Epylisis and Ansys in Dimension Lab 3D, Hospital de la Santa Creu i Sant Pau by biomedical engineers.
The source of information is the journals and journals specialized in hand surgery, bioengineering, biotechnology and biomedical engineering.
The principal investigator and collaborators are responsible for creating the database and entering data. Statistical analysis requires support from the statistics unit of the UICEC/Hospital de la Santa Creu i Sant Pau. All data will be collected in REDCap.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Claudia Lamas, MD, Ph D
- 電話番号：7032 00-34-5537032
- メール：clamasg@santpau.cat
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Primary Osteoarthritis in thumb CMC joint in the hand
- Adults aged between 50 and 88 years old included.
- Thumb CMC joint osteoarthritis, radiographic stages II, III and IV by Eaton- Littler classification (1973).
Exclusion Criteria:
- Asymptomatic primary osteoarthritis in thumb CMC joint
- Patients with osteoarthritis and age less than 50 years or more than 88 years.
- Patients who have had previous interventions in the area, in this joint, injuries in this hand or fractures.
- Patients with rheumatic diseases or collagen diseases that create joint instability.
- Patients with physical or mental conditions that preclude intervention.
- Thumb CMC joint osteoarthritis, radiographic stages I by Eaton-Littler classification (1973)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Suspension-resection arthroplasty
This is a usual surgical treatment for patients with chronic pain and thumb CMC joint osteoarthritis. The clinical management of the patients will be adapted to the treatment standards of the Orthopedic Surgery and Traumatology Service of the Hospital de la Santa Creu i Sant Pau, without the performance of this study influencing this process. Procedure performe with a suspension-resection arthroplasty by modified Welby´s technique. Dorso-lateral approach. Complete resection of the trapezium and joint stabilization with tendon interposition arthroplasty. After resection a distally based strip of the Abductor Pollicis Longus tendon is looped along the Flexor Carpi Radialis tendon. After surgical intervention the immobilization is one month with a plaster cast. |
Carpometacarpal arthroplasty without implant: Trapezectomy and ligamentoplasty.
他の名前：
|
|
Chronic pain and Thumb carpometacarpal (CMC) osteoarthritis: Trapeziometacarpal joint prosthesis
This is a usual surgical treatment for patients with chronic pain and thumb CMC joint osteoarthritis. The clinical management of the patients will be adapted to the treatment standards of the Orthopedic Surgery and Traumatology Service of the Hospital de la Santa Creu i Sant Pau, without the performance of this study influencing this process. Procedure performe with a thumb CMC joint prosthesis. Dorso-lateral approach. Insertion of a dual mobility trapeziometacarpal joint prosthesis. The Prosthesis consists of a hemispherical cup, a modular neck and of an anatomical metacarpal stem. It offers a complete range of implants allowing the choice between single and double mobility. After surgical intervention the immobilization is one month with a plaster cast. |
Joint carpometacarpal prostesis
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Thumb carpometarcarpal joint radiological evaluation
時間枠：12 months
|
Standard radiographs are required x-rays in posteroanterior (PA), PA in pronation (Robert´s view) and lateral views for assessment of the radiological stages of Eaton-Littler modified by Eaton-Glicker classification (1973).
This classification include four stages of progression of the loss cartilage in thumb CMC joint, from I to IV.
The X-rays will made in clinics at 6 weeks, 3 months, 6 months and 12 months after the surgical repair.
|
12 months
|
|
Thumb carpometacarpal joint CT scan evaluation
時間枠：12 months
|
A Computed Tomography (CT) scan is also required for the initial evaluation and regular control of these patients.
For each participant, CT scans will be perform in static limb positions before and after the surgery.
|
12 months
|
|
3D modeling and finite element methods of evaluation of the CT scan before and after surgical intervention.
時間枠：12 months
|
In each patient will be performed with the computed specific software Epylisis and Ansys in Dimension Lab 3D, Hospital de la Santa Creu i Sant Pau by biomedical engineers. To obtain the 3D geometrical information for a subject-specific finite element human hand, CT images will take from patients. Each scan is recontructed in a Digital Imaging and Communications in Medicine (DICOM) format. These 2D data (DICOM data collection) are process using medical image processing software Mimics (Materialise, Leuven, Belgium). All the CT images will be segmented manually into the bones and skin, while subcutaneous tissues and tendons will be reconstructed based on CT images. A specific software (Epylisis, Ansys) will be used to simulated the loads in the thumb CMC joint. Epylisis is one of this specific software based on the Finite Element Methods (FEM), enables computational simulation of the biomechanical behavior of the trapeziometacarpal joint. It is used to conduct mechanistic analyses |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain pre and postoperative
時間枠：12 months
|
A Visual Analoge Scale (VAS) is used to assess pain (range, 0-10).
This scale is from 0, no pain to 10, uncontrollable pain.
|
12 months
|
|
Pinch force pre and postoperative
時間枠：12 months
|
A pinch Jamar dynamometer is used to measure pinch force, scale from 0-30 Kilograms (Sammons Preston, Bolingbrook, IL, USA).
|
12 months
|
|
Grip Strength pre and postoperative
時間枠：12 months
|
A Jamar dynamometer is used to assess grip strength, scale from 0 to 90 Kilograms (Sammons Preston, Bolingbrook, IL, USA).
|
12 months
|
|
Range of motion
時間枠：12 months
|
A goniometer is used to assess the thumb CMC range of motion (flexion, extension, adduction, abduction), measure in grades from 0-90º.
|
12 months
|
|
Questionnaire QuickDash
時間枠：12 months
|
The clinical and functional outcomes is evaluate using the Questionnaire QuickDash, Disabilities of the Arm, Shoulder and Hand, consist of 30 items (11 items, scored 1-5).
The QuickDASH score ranges from 0 (no disability) to 100 (most severe disability).
|
12 months
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- van Cappelle HG, Elzenga P, van Horn JR. Long-term results and loosening analysis of de la Caffiniere replacements of the trapeziometacarpal joint. J Hand Surg Am. 1999 May;24(3):476-82. doi: 10.1053/jhsu.1999.0476.
- Imaeda T, Cooney WP, Niebur GL, Linscheid RL, An KN. Kinematics of the trapeziometacarpal joint: a biomechanical analysis comparing tendon interposition arthroplasty and total-joint arthroplasty. J Hand Surg Am. 1996 Jul;21(4):544-53. doi: 10.1016/S0363-5023(96)80002-5.
- Vermeulen GM, Brink SM, Sluiter J, Elias SG, Hovius SE, Moojen TM. Ligament reconstruction arthroplasty for primary thumb carpometacarpal osteoarthritis (weilby technique): prospective cohort study. J Hand Surg Am. 2009 Oct;34(8):1393-401. doi: 10.1016/j.jhsa.2009.06.019. Epub 2009 Sep 6.
- Vadstrup LS, Schou L, Boeckstyns ME. Basal joint osteoarthritis of the thumb treated with Weilby arthroplasty: a prospective study on the early postoperative course of 106 consecutive cases. J Hand Surg Eur Vol. 2009 Aug;34(4):503-5. doi: 10.1177/1753193409105084. Epub 2009 Jul 8.
- Spartacus V, Mayoly A, Gay A, Le Corroller T, Nemoz-Gaillard M, Roffino S, Chabrand P. Biomechanical causes of trapeziometacarpal arthroplasty failure. Comput Methods Biomech Biomed Engin. 2017 Aug;20(11):1233-1235. doi: 10.1080/10255842.2017.1348502. Epub 2017 Jul 4.
- Murai A, Kurosawa A, Tada K, Tachiya H, Tamai A, Akahane M, Matsuta M, Nakamura Y, Kawashima H, Tsuchiya H. Optimal Center of Rotation for Ball-And-Socket Thumb Carpometacarpal Arthroplasty Identified Using Three-Dimensional Kinematic Analysis: A Pilot Study. Front Bioeng Biotechnol. 2022 Jun 1;10:868150. doi: 10.3389/fbioe.2022.868150. eCollection 2022.
- Kerkhof FD, Schneider MTY, Shelby T, Weiss AC, Moore DC, Crisco JJ, Ladd AL. Morphological changes to peripheral joints supporting thumb trapezial metacarpal osteoarthritis. J Biomech. 2025 Feb;180:112519. doi: 10.1016/j.jbiomech.2025.112519. Epub 2025 Jan 7.
- Hansen TB, Stilling M. Equally good fixation of cemented and uncemented cups in total trapeziometacarpal joint prostheses. A randomized clinical RSA study with 2-year follow-up. Acta Orthop. 2013 Feb;84(1):98-105. doi: 10.3109/17453674.2013.765625. Epub 2013 Jan 23.
- Dong M, Kerkhof F, Deleu G, Vereecke E, Ladd A. Using a finite element model of the thumb to study Trapeziometacarpal joint contact during lateral pinch. Clin Biomech (Bristol). 2023 Jan;101:105852. doi: 10.1016/j.clinbiomech.2022.105852. Epub 2022 Dec 5.
- D'Agostino P, Dourthe B, Kerkhof F, Vereecke EE, Stockmans F. Impact of Osteoarthritis and Total Joint Arthroplasty on the Kinematics of the Trapeziometacarpal Joint: A Pilot Study. J Hand Surg Am. 2018 Apr;43(4):382.e1-382.e10. doi: 10.1016/j.jhsa.2017.10.011. Epub 2017 Nov 14.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IIBSP-BIE-2025-145
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。