跳至主要内容
临床试验/CTRI/2020/02/023593
CTRI/2020/02/023593招募中不适用

Pilot study using novel technique for restoring the limb length in patients undergoing bipolar cemented hemiarthroplasty, using preoperative scaled radiographs of the normal side

Amir Ratna Shakya1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年2月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Achieve equal leg length in patients of fracture of proximal femur undergoing Hemi-Replacement Arthroplasty by using Scaled Pre-operative radiographs

研究概览

简要总结

Fracture around proximal femur are a commonlyencountered fracture in the older population with a globally increasingincidence. The incidence of the fracture around proximal femur also riseswith age. Among the fractures ofproximal femur the incidence of intertrochanteric fracture is around 55 % fractureneck of femur is around 32%.

Fractures around the hip are associated withincreased mortality rate, incidence being around 8-11% at the end of 30 daysand 20-30% at the end of 01 year. A delay in surgery is due to variousfactors  such as associatedco-morbidities requiring pre-operative optimization  in these group of patients and subsequentsurgery readiness and resource availability factors such as high volume ofcases.

In order to achieve the goals of fracturemanagement the options are primarily surgical with options including reductionand internal fixation or arthroplasty. Arthroplasty can be either Hemi-replacementArthroplasty (HRA) or Total Hip Arthroplasty (THA). HRA in current practice isof two types: unipolar and bipolar. HRA is generally indicated in olderpatients with a aim to regain early mobilization and better functional results.HRA prevents the bed ridden state and thus avoids the complications associatedwith recumbency.

In order to achieve better functional resultsfollowing HRA the hip biomechanics need to be restored to its native state. Thefemoral offsets and limb length are the factors that decide the biomechanics ofthe operated hip. Inability to restore the leg length has shown to beassociated with back pain, gait abnormalities, dislocation,prosthesis loosening and poor functional capacity.

Incidence of limb length discrepancy followinga HRA with a unipolar prosthesis is as high as 50% when the difference isminimum 10 mm. whereas in bipolar Arthroplasty the incidence decreases butis more when compared to THA

There are various means of reducing theincidence of LLD described in literature in patients undergoing Total HipArthroplasty. These methods were broadly classified by Khanduja et al  into 03 groups a) those which rely on preoperative templating and determinationof the osteotomy site with intra-operative determination of the osteotomy sitein relation to the lesser trochanter; b) those using intra-operative pelvic andfemoral markers for reference and; c) experimental methods which employ complexmathematical calculations and ultrasound probes to measure leg lengthsaccurately.

However there is limited available literatureon methods of reduction of limb length discrepancy in patients of proximalfemur fracture undergoing Hemi-replacement Arthroplasty. Methods used aretaking reference of the greater trochanter in relation to head of femur onnormal side and pre-operative templating and estimating the size of prosthesis

This study will be undertaken at a tertiarycare center in western part of India in patients of fracture of proximal femurundergoing Hemi-replacement Arthroplasty and wherein Pre-operative ScaledRadiograph shall be taken and a novel technique using fixed accessiblelandmarks will be used to assess the level of cuts intraoperatively with a aimto achieve equal limb length or minimize limb- length discrepancy.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

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

入选标准

  • Patient with fracture of proximal femur undergoing hemi-replacement arthroplasty as the management.

排除标准

  • Patient being managed with other surgical options like THR Patient with an operated or affected contralateral hip Patient unfit for surgery.

结局指标

主要结局

Achieve equal leg length in patients of fracture of proximal femur undergoing Hemi-Replacement Arthroplasty by using Scaled Pre-operative radiographs

时间窗: Post operative period

次要结局

  • To study and analyze the post-operative functional status.(01 and 03 months functional assessment using Harris hip Score (HHS))

研究者

发起方
Amir Ratna Shakya
申办方类型
Other [afmc]

研究点 (1)

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