CTRI/2025/01/079405尚未招募不适用
Clinical and radiological outcome of internal fixation of fracture neck of femur in adults using femoral neck system
Dr Soham Sadekar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- -Fracture union rate(RUSH)
研究概览
简要总结
- Purpose of this study is to assess the results of Femoral neck system in treatment of fracture neck of femur. This study will be conducted from December 2024 to April 2026 and will recruit 50 or more participants. The study will involve analyzing the results of Femoral neck system in fracture neck of femur by observing the progress in patients treated with the same. This will include detailed history taking, clinical examination, study of X-rays of the participants. Femoral neck system is standard of care in fracture neck of femur. All adult patientswithFemur neck fractures planned for Internal fixation with Femoral neck system will be included in this study. Pre-operative clinical assessment will include Recording Harris hip score, Charite mobility index and pain as per visual analogue scale for all patients at presentation. Radiological assessment will include Recording femur neck length and femur neck shaft angles from X-rays at presentation. Post-operative assessment will be done Immediate post-op and at 6 weeks, 3 months, 6 months, 9 months and 1 year follow-ups [The follow up durations are routinely followed as standard of care and not done for purpose of study] which will include Recording Harris hip scores, Charite mobility index and pain. Radiological assessment will include noting Fracture union [RUSH), Non-union, loss of fixation, Avascular necrosis of femoral head. Femoral neck fractures are very common and account for over 50% of all hip fractures. Standard treatment for fracture neck of femur is surgical. The surgical treatment can either be internal fixation or arthroplasty depending on the age of the patient. The novel technique of FNS developed in 2018 is a relatively minimally invasive procedure which reduces blood loss and infection risk. Biomechanical studies have shown axial and rotational stability, operative time, union rates and stability of FNS are similar to other surgical options while being superior in terms of intraoperative blood loss, non- union, internal fixation failure and betterment of Harris hip scores. There are few reports discussing clinical implementation of FNS out of which most are retrospective in nature and include a small cluster of patients. Intra-operative and Post-operative parameters of FNS have not been fully explored. This study will increase the available data on femoral neck system surgery and may provide more clarity on its outcomes. It will also help in validating the previous studies done by reproducing the results.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients [aged above 18 years] diagnosed with fracture neck of femur and treated with internal fixation by femoral neck system at Kasturba hospital, Manipal.
排除标准
- •Patients with other associated lower limb/hip fractures in ipsilateral or contralateral limb -Patients with diagnosed psychiatric disorders or cognitive dysfunction unable to rpovide accurate history/complains -Patients with pathological fractures.
结局指标
主要结局
-Fracture union rate(RUSH)
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
-time to union
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
-Loss of fixation
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
-Harris hip score
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
-non-unions
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
-development of Avascular necrosis
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
-Visual analogue scale.
时间窗: -Immediate post-op | -6 weeks | -3 months | -6 months | -9 months | -1 year
次要结局
- -Time to union(-Loss of fixation)
研究者
Dr Soham Sadekar
Kasturba Hospital, MAHE, Manipal
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FNFemoral Neck FracturesNCT00830687Sheba Medical Center100
已完成
不适用
Dynamic Internal Fixation of Femoral Neck FracturesFemoral Neck FractureNCT00779948Aesculap AG171
招募中
4 期
Clinical outcomes of femoral neck fracture fixation: Femoral neck system versus Cannulated screws, A randomized control trialFemoral neck fracture patient requiring surgical fixationHip fracture, Femoral neck fracture, Femoral neck system, Cannulated screwsTCTR20230116002Rajavithi hospital28
进行中（未招募）
不适用
Open vs Closed Reduction in Femoral Neck Fractures Using Anterolateral vs Direct Lateral ApproachNCT07299370Samer youssef mansour meglaa3
尚未招募
3 期
A study to compare results of two different surgeries for treating loss of blood supply of the femoral head in children.CTRI/2025/03/082864Internal - Fluid Research Grant20