Cemented Hemiarthroplasty in Femoral Neck Fractures; Are Clinical Results Affected by Surgical Approach. A Randomized Clinical Trial Comparing Posterior and Anterior Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Harris Hip Score
研究概览
简要总结
Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.
详细描述
The investigators have witnessed a marked change in preferred anatomical route to the hip joint when performing total hip artrhroplasty (THA) for osteoarthritis in Norway. The direct lateral approach, which 10 years ago dominated, is today more or less abandoned. Several studies have reported inferior results in patients operated with the lateral approach compared to the posterior and anterior approaches, the latter approaches used in approximately 95 % of all THA´s i Norway. Many approaches are known for hip arthroplasty in trauma patients, but there is little consensus on the preferred method. The preferred surgical approach varies among hospitals and surgeons. Identifying the best possible approach for HA could lead to shorter hospital admission, faster rehabilitation, better functional outcomes, lower morbidity and mortality and improvement in patient independence. Consequently healthcare costs related to a hip fracture could be reduced.
As of today the clinical results, reoperation rate and the morbidity have improved significantly in hemiarthroplasty treatment for dislocated femoral neck fractures. However, patients are primarily operated with the lateral approach, although inferior results are reported compared to posterior and anterior approaches. RCT´s from Ugland et al and Mjaaland have shown increased incidence of limping, lateral thigh pain and inferior PROM´s in patients operated with the direct lateral approach compared to patients operated with anterior approaches.
A meta-analysis regarding hemiarthroplasty and surgical approaches from 2018 concluded that high-quality comparative studies are needed to further substantiate the preferred anatomic route for hemiarthroplasty in older femoral neck fracture patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Outcome assessors are blinded to allocation by not having access to patients study protocol and by examining patients covering their operated hip with clothing.
Patients are attempted blinded by using wound dressings to cover their operated hip and are, unless expressing specific interest in knowing the surgical approach, not informed of the randomization result. To evaluate the blinding of patients we will record their knowledge of which surgical approach they were operated with at their 12-month follow-up.
入排标准
- 年龄范围
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 70 and 90 years of age
- •Displaced FNF
- •Ability to walk with or without a walking aid prior to falling
- •Patients having Sorlandet Hospital as primary service provider for orthopaedic trauma
- •Provision of informed consent by patient or proxy
- •Low energy fracture (fall from standing height, no other major trauma)
排除标准
- •Fractures in pathologic bone
- •Patients not suited for HA (i.e., inflammatory arthritis, severe osteoarthritis)
- •Associated major injuries of the lower extremity ( i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula or femur)
- •Retained hardware around the affected hip that will interfere with arthroplasty
- •Sepsis or local infection
研究组 & 干预措施
cemented hemiarthroplasty , posterior SPAIRE approach
Posterior SPAIRE approach: lateral decubitus position, preservation of the piriformis tendon and obturator internus, detatchment of obturator externus , capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair, repair of obturator externus.
干预措施: Posterior SPAIRE approach, anterior approach (Procedure)
cemented hemiarthroplasty, anterior approach
Anterior approach: supine position, both legs washed and draped, intermuscular plane between m. tensor fascia lata and m. sartorius, capsular T-incision, femoral neck resection, femoral canal reaming according to preoperative templating, third generation cementation technique, capsular repair
干预措施: Posterior SPAIRE approach, anterior approach (Procedure)
结局指标
主要结局
Harris Hip Score
时间窗: 2 years
The posterior SPAIRE and the anterior approach in HA for femoral neck fractures results in equivalent patient reported outcome measured by Harris Hip Score.
次要结局
- Bone Mineral Density(2 years)
- Radiographic stem positioning(2 years)
- Muscle damage(2 years)
- Health-related quality of life (HRQoL)(2 years)