이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Biomechanical Evaluation With Finite Element Models in Thumb Carpometacarpal Osteoarthitis: Prospective Comparative Analysis of Loads in Arthroplasty With or Without Implants

2026년 5월 25일 업데이트: Claudia Lamas, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
To better understand the load distribution in the Thumb Carpometacarpal Joint (CMC joint) in presence of osteoarthritis and how surgery by means of a suspension-resection arthroplasty or a joint replacement by means of a metal prosthesis affects this load distribution. These studies allow to supporting medical decisions and surgical treatments results with biomechanical evidence.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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

40

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Claudia Lamas, MD, Ph D
  • 전화번호: 7032 00-34-5537032
  • 이메일: clamasg@santpau.cat

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

Adult patients with chronic pain and thumb CMC joint osteoarthritis that need surgical treatment.

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
다른 이름들:
  • trapezium resection ligamentoplasty arthroplasty
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
다른 이름들:
  • Trapeziometacarpal arthroplasty with implant

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Thumb carpometarcarpal joint radiological evaluation
기간: 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
기간: 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.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pain pre and postoperative
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2026년 11월 25일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 15일

QC 기준을 충족하는 최초 제출

2026년 5월 25일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 25일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다