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临床试验/NCT05346926
NCT05346926已完成不适用

Overnight and In-house 3D-printed Patient-specific Casts for Non-operative Treatment of Distal Radius Fractures - a Prospective Randomized Trial

Alissa Gubeli2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Score of clinical effectiveness questionnaire

研究概览

简要总结

The aim of this prospective randomized trial is the acquisition and evaluation of data to assess the relevance, feasibility and safety of forearm casts based on 3D-printing technology in the nonoperative treatment of distal radius fractures.

详细描述

The study design is planned according to similar studies investigating the treatment of distal radius fractures.

Upon the patient's arrival at the emergency unit, the distal radius fracture is examined following the same scheme as before. The wrist is x-rayed in two planes. If there is a distal radius fracture and none of the exclusion criteria apply, the patient is included in the study after giving their consent in writing. The patients are then assigned to the "conventional cast" group (Group A) or the "3D print cast" group (Group B) in randomized trial, either immediately during the emergency consultation or within a week during hand surgery consultation hours. For initial immobilization, a thermoplastic cast splint is used as before. Depending on the randomization, the cast is changed to a Scotchcast cast (Group A) or a 3D printed cast (Group B). Further treatment of both groups occurs based on the same algorithm as before (see below).

The cast for Group B are produced using 3D print technology based on software by a Belgian company, our collaborators: The patient's forearm is scanned with a tablet (duration: approx. 5 min), whereupon the cast is printed overnight according to the scan (duration: approx. 4h) and adjusted to the patient during the next appointment.

The patients are examined after 1, 6, 12, 26 and 52 weeks in the outpatient clinic. Follow up x rays, patient satisfaction and clinical efficacy questionnaires and clinical examinations are conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Undisplaced or minimally displace distal radius fractures

排除标准

  • Age < 18yrs.
  • Dorsal dislocation (dp angle) >20°
  • Palmar dislocation
  • Ad latus dislocation
  • Radio-/ulnar angulation in the coronary plane
  • Symptoms of neurologic affection (Median nerve)
  • Bilateral fractures
  • Previous ipsilateral distal radius fracture
  • The patient is unable to give informed consent due to physical or mental impairment
  • The patient is unavailable for follow-up examinations (foreign country, Polytrauma, etc)
  • The patient is under legal custodianship
  • C2- or Drug-abuse or expected incompliance
  • Hypersensitivity/Allergy to one or more components of the used casts
  • Pregnancy/Intention to become pregnant during the course of the study

结局指标

主要结局

Score of clinical effectiveness questionnaire

时间窗: 1 year

quantified with questionnaire (0-12, 0=worst result)

Score of modified patient satisfaction questionnaire

时间窗: 1 year

quantified with questionnaire (0-12, 0=worst result)

次要结局

  • Fracture healing(1 year)
  • Amount of grip strength in (N/kg)(1 year)
  • Score of Disabilities of Arm, Shoulder and Hand(1 year)
  • Score on Visual Analogue Pain Scale(1 year)
  • Amount of range of motion in degrees(1 year)

研究者

发起方
Alissa Gubeli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alissa Gubeli

Junior Consultant Hand Surgery

Kantonsspital Baselland Bruderholz

研究点 (2)

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