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临床试验/CTRI/2024/05/066949
CTRI/2024/05/066949尚未招募不适用

Can 3-D printing and virtual reality improve outcomes in periarticular fractures - a double blinded randomized controlled trial?

PGIMER, Chandigarh1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
168
试验地点
1
主要终点
a) Accuracy of fracture reduction

研究概览

简要总结

Objective: The aim of this randomized controlled trial (RCT) is to evaluate the efficacy of 3D printing and virtual reality (VR) for the surgical planning of periarticular fractures in adults.

Methods: This is a double-blinded RCT that will include 168 adult patients with periarticular fractures (proximal humerus, elbow, distal radius, carpal, pelvis-acetabular and hip, distal femur, proximal tibia, ankle, and foot fractures), who will be randomized into two groups. Patients and outcome assessors will be blinded. Group A will undergo conventional surgical planning, while Group B will have 3D printing and VR as planning tools. Patients in both groups will be assessed for accuracy of fracture reduction, operative time, blood loss, radiation dose, surgeon satisfaction, functional outcomes, complications, and cost-efficiency. The t-test will be used to compare continuous variables, and the chi-squared test will be used for variables.

Expected Outcome: The results of this RCT will provide insight into the effectiveness of using 3D printing and VR in periarticular fracture management. The use of 3D printing and VR in periarticular fracture management has shown promising results in previous studies, but their effectiveness and safety need to be evaluated through a robust RCT. The results of this trial will help determine the benefits and limitations of these new technologies in periarticular fracture management.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adult patients (18 years and above) with an acute (less than 3 weeks from the date of injury) periarticular fracture of the shoulder, elbow, wrist, hip, knee, ankle, or foot, where a CT study has been performed, and operative reduction and internal fixation is indicated, will be included.
  • The following AO OTA 2018 fracture categories will be included: 11, 13, 14, 15.1, 15.3, 2R1, 2U1, 2R3, 2U3, 71, 72, 73, 74, 75, 76, 6, 31, 33, 34, 41, 4F1, 43, 4F3, 44, 8.

排除标准

  • Pediatric patients, diaphyseal fractures, non-operatively managed patients, patients managed only with external fixation, patients unwilling to participate and those where CT has not been performed will be excluded.

结局指标

主要结局

a) Accuracy of fracture reduction

时间窗: 6 weeks, 3 months, 6 months, 12 months

b) Length of operative time

时间窗: 6 weeks, 3 months, 6 months, 12 months

c) Intraoperative radiation

时间窗: 6 weeks, 3 months, 6 months, 12 months

d) Surgeon satisfaction

时间窗: 6 weeks, 3 months, 6 months, 12 months

e) Perioperative blood loss

时间窗: 6 weeks, 3 months, 6 months, 12 months

Secondary Outcomes

时间窗: 6 weeks, 3 months, 6 months, 12 months

a) Time to union

时间窗: 6 weeks, 3 months, 6 months, 12 months

b) Functional outcomes: EQ5D, SF36, region specific functional outcome scores

时间窗: 6 weeks, 3 months, 6 months, 12 months

c) Cost efficiency analysis

时间窗: 6 weeks, 3 months, 6 months, 12 months

次要结局

  • a) Accuracy of fracture reduction(b) Length of operative time)
  • a) Time to union(b) Functional outcomes: EQ5D, SF36, region specific functional outcome scores)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Siddhartha Sharma

Postgraduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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