跳至主要内容
临床试验/CTRI/2024/08/072623
CTRI/2024/08/072623尚未招募3 期

Efficacy of Functional Outcome of Variable Angle - Olecranon Locking Plate versus Conventional Olecranon Locking Plate Fixation in Comminuted Olecranon Fracture - A Randomized Control Trial

Uttar pradesh university of medical sciences . Saifai , Etawah1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
effectiveness of variable angle olecranon plate and conventional olecranon plate in comminuted olecranon fracture

研究概览

简要总结

Title of study  is Variable Angle (VA) - Olecranon Locking Plate v/s Olecranon Locking Plate Fixation in Comminuted Olecranon Fracture – A Randomized control trial.

Olecranon fractures are one of the most commonly seen orthopaedic injuries in the emergency room comprising approximately 10-20% of all upper extremity fractures with an incidence of 11.5 per 100000 population per year. (1-5) Fractures of the olecranon show bimodal age distribution with younger individuals sustaining a fracture due to high energy trauma and older individual as a result of a simple fall due to osteoporosis. Fractures of the olecranon process of the ulna typically occur as a result of direct trauma such as falling on the tip of the elbow or by indirect trauma such as falling on a partially flexed elbow with indirect forces generated by a strong sudden eccentric contraction of the triceps avulsing the olecranon.

Olecranon fractures are common injuries of the upper extremity; majority Nonetheless, good results over all are to be expected after surgical management. Cost effective implant selection in orthopaedic trauma is essential in the current era of managed healthcare delivery. Both locking plates and variable angle (VA) – olecranon locking plates have been utilized in the treatment of comminuted fractures of the olecranon .

Aim and Objectives:

• Primary objectives

  • To evaluate outcome of olecranon locking plating in Comminuted

Olecranon fracture .

  • To evaluate outcome of variable angle olecranon locking plate in Comminuted Olecranon fracture .

  • to compare the function outcome of Locking v/s Variable angle locking plate in Comminuted Olecranon fracture .

• Secondary Objectives

  • To evaluate the demographics profile of Olecranon fracture

Written informed consent will be taken from all potential eligible subjects, patients will be equally divided into two groups on the basis of treatment modality GROUP A :- Fixation with olecranon locking plate

GROUP B :- Fixation with Variable angle (VA)- olecranon locking plate

The first follow-up will be at 6 weeks (patients will be informed to follow up immediately if any problem related to the elbow surgery) and subsequent follow- ups will be done at 3 months, 4.5 months and at 6 months, . At every follow-up visit of the patient, the functional mayo elbow performance score 29 will be assessed and compared for any improvement or deterioration in the outcome .

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with Closed Comminuted olecranon fracture and Open Comminuted olecranon fracture ( Grade 1 Gustilo Anderson ) .
  • Good joint function before elbow injury
  • Patients giving written informed consent will be taken.

排除标准

  • Patienyts with fractures of other parts of the elbow joint ( distal humeurs, radial head, coronoid process )
  • Patients with severe complications and inoperable
  • undisplaced fracture fragments or fragments displacement less than 2mm
  • Time of injury to operation more than 2 weeks.

结局指标

主要结局

effectiveness of variable angle olecranon plate and conventional olecranon plate in comminuted olecranon fracture

时间窗: outcome will be assessed at 1.5 month , 3 month , 4 month and 6 month from intervention

次要结局

  • - To evaluate the demographics profile of Olecranon fracture(1.5 month , 3 month , 4 month , 6 month)

研究者

发起方
Uttar pradesh university of medical sciences . Saifai , Etawah
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Aman Kumar Srivastava

UPUMS , Saifai

研究点 (1)

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