- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04892862
주상골 가관절증에서 배측 및 손바닥 수술 선호 운동학적 효과 비교
Our aim is to objectively analyze the effects of the non-vascularized autograft taken from the radius and the dorsal and volar surgical approach on the preop and postop wrist kinematics and the movements we use frequently in daily life, and to present the results.
연구 개요
상태
정황
상세 설명
At least 23 working male patients between the ages of 20-50 who do not have active additional diseases will be included in the study, and those who have not previously had trauma or surgical intervention on the same extremity, and who do not have vascular and neurological fields, These patients will be followed-up at the itf orthopedic clinic and the medical faculty orthopedics clinic. their patients will be After the preop and postop union is provided to the patients who will be divided into 2 groups of at least 10 people (in the 12th month postop), the wrist motion analysis will be performed with the XSENS MTw Awinda 17 sensor full body motion capture system in the Bahçeşehir University biomechanics laboratory (separate on the healthy side). In addition to the rum, 5 movements such as personal wc cleaning, drinking coffee from the cup will be stimulated by looking at the healthy side.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Fatih
-
Istanbul, Fatih, 터키 (Türkiye)
- Istanbul University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion
- healty male
- without any chronic systemic dissease
- must not have drug addiction
- must not have surgical prosedure on affected upper extremity before
- patient shouldnt have VISI DISI DEFOMİTY and radiocarpal arthrosis on affected wrist
- there must be minimum 1 year maximum 10 year between trauma and surgery
Exclusion Criteria:
- Criteria:having vascular and neurological spaces in the same extremity without previous trauma or surgical intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: dorsal surgical approach
dorsal surgical approach |
ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . LISTER TUBERCULA WITH 3 CM PROXIMAL AND 3 CM DISTAL IN INCISION MADE UNDER THE SKIN. 2,3 EXTENSOR COMPARTMENTS RADIAL 4. THE EXTENSON COMPARTMENT IS EARTHED TO ULNAR A AND THE WRIST JOINT CAPSULE IS REACHED. THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision ON DISTAL UNDER RADIUS metaphyseal area of 2CM. 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures. |
|
활성 비교기: volar surgical approach
volar surgical approach |
ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . İNCİSİON STARTS 2 CM RADİAL TO SCAPHOİD TUBERCULE EXTENTS ITS 3 CM PROXİMAL . AFTER PASİNG SUBCUTANEOUS TİSSUE , FCR AND RADİAL ARTERY ARE İDENTİFİED AND DİVİDED SEPERATLY THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision WİTH PASSİNG PRONATOR QUADRATUS MUSCLE , ON DISTAL UNDER 2 CENTİMETER OF RADIUS metaphyseal area . 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
CHANGES İN WRİST RANGE OF MOTİON
기간: preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year
|
measure wrist range of motion with goniometer |
preoperation , postop 3. week, 6. week, 3.month, 6. month and avarage of first year
|
|
assess bone union
기간: 3 weeks to 3 months post-op
|
assesing union on wrist antero-posterior/ lateral x-rays, by identification of trabeculae crossing the fracture line or sclerosis at the fracture line |
3 weeks to 3 months post-op
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
DASH score
기간: preoperation , avarage of first year after operation
|
Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. The DASH questionnaire is used as an indicator of the impact of an impairment on the level and type of disability we expect decrease after operation |
preoperation , avarage of first year after operation
|
|
HAND MAYO SCORE
기간: preoperation , avarage of first year after operation
|
Mayo Wrist Score -- OrthoToolKit Scores range from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition. Original Literature: Cooney, W. P., et al. "Difficult wrist fractures. |
preoperation , avarage of first year after operation
|
|
VAS SCORES
기간: preoperation , avarage of first year after operation
|
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." |
preoperation , avarage of first year after operation
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
key pinch ,
기간: preoperation , avarage of first year after operation
|
each patient will do Lateral pinch (key pinch): Place the pinchmeter between the radial side of index finger and thumb, and instruct the client to pinch as hard as possible) , pinchmeter measures in pound( 1 lb=0.45kg) |
preoperation , avarage of first year after operation
|
|
measurement of range of motions in tasks with xsens motion capture system
기간: preoperation , avarage of first year after operation
|
we have determined four tasks (drinking coffe,reaching tail bone from front,using phone,reaching backpack from back ) we repeated task 3 times measured wrist range of motions during tasks , |
preoperation , avarage of first year after operation
|
|
jamar hand dynomometer
기간: preoperation , avarage of first year after operation
|
prosedure with both hands which describe in ''Optimal Jamar Dynamometer Handle Position to Assess Maximal Isometric Hand Grip Strength in Epidemiological Studies'' Ulrike Sonja Trampisch, PhD, Julia Franke, PhD, Nina Jedamzik, MSc, Timo Hinrichs, MD, Petra Platen, MD, three times most high value will accept (jamar dynomometer measures in kilogram unit , |
preoperation , avarage of first year after operation
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2020/779
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .