ProspEctive Cohort Study on Integrated and Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in T-Score at follow-up
研究概览
简要总结
Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after intertrochanteric hip fractures. This study evaluates gait and mobility after surgical fixation of IT fractures in elderly population with Gait Analysis in combination with clinical and radiographic information.
详细描述
Hip fractures are an increasing public health concern as the population continues to age. The increased morbidity and mortality in the 12-month period after hip fracture is largely related to decreased mobility. However, very few studies have analyzed the radiographic factors associated with gait impairment after InterTrochanteric (IT) hip fractures. Improving gait and mobility after surgical fixation of IT fractures is one important target of research efforts.
All the patients with IT hip fractures (AO/OTA 31) treated between October 2017 and April 2018 were enrolled. Inclusion criteria consisted of age older than 65 years, previous walking ability, no neurological disease and no other musculoskeletal disorders. The study was approved by the institutional review board of the Local Ethical Committee (reference number 5559). All patients provided written informed consent for participation in the study.
All patients were treated with intramedullary nailing (IMN) or hemiarthroplasty (HA) according to the current international guidelines and to their clinical history.
Radiographs were analyzed at the time of surgery and at each follow-up visit. Clinical outcomes were assessed according to the Harris Hip Score (HHS) and Western Ontario and Mc Master University (WOMAC).
At 6- and 12-months follow-up appointments, gait parameters were measured and recorded in our Gait Analysis Laboratory (BTS Bioengineering SpA, Italy) located in AOUC Policlinico di Bari (Rehabilitation Unit). All participants performed several walking trials at their natural speed. All patients were fitted with full-body external reflective markers placed according to Davis' procedures. A static video trial was recorded with subjects positioned in a neutral standing posture to create a reference for defining neutral joint angles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age older than 65 years
- •previous walking ability
- •surgical procedure (intramedullary nailing or hemiarthroplasty)
排除标准
- •neurological diseases
- •musculoskeletal disorders
- •cardiovascular diseases
结局指标
主要结局
Changes in T-Score at follow-up
时间窗: 12- months
T-score is the relevant measure when screening for osteoporosis extracted from Dual energy X-ray Absorptiometry (DXA). It is the bone mineral density (BMD) at the site when compared to the young normal reference mean. A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates that you have low bone mass, although not low enough to be diagnosed with osteoporosis. A T-score of -2.5 or lower indicates that you have osteoporosis. The greater the negative number, the more severe the osteoporosis.
Changes in HHS at follow-up
时间窗: 12- months
Harris Hip Score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.
Changes in Temporal Parameters of Gait at follow-up
时间窗: 12- months
Gait Analysis will be performed in two different time points and parameters related to temporal characteristics of gait during a gait cycle will be estimated (expressed in percentage): stance phase (%), swing phase (%)
Changes in WOMAC at follow-up
时间窗: 12- months
Western Ontario and Mc Master University Scale evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.
Changes in Spatial Parameters of Gait at follow-up
时间窗: 12- months
Gait Analysis will be performed in two different time points and parameters related to spatial characteristics of gait during a gait cycle will be estimated: stride length (m), step length (m), step width (m).
次要结局
- Changes in ROM of Kinematic Angles(12- months)
- GGA-g Index(12- months)
- GGA-a Index(12- months)
研究者
Biagio Moretti, MD
Full Professor
University of Bari