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临床试验/NCT01770769
NCT01770769Unknown不适用

Undisplaced Femoral Neck Fractures in Patients Aged 70 Years and Older: A Multicentre Randomised Controlled Trial Comparing Internal Fixation to Hemiarthroplasty

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2012年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
220
试验地点
2
主要终点
Change in Harris Hip Score of 10 points or more.

研究概览

简要总结

Clinical research during the last ten years has revealed that elderly patients with a displaced femoral neck fracture should be treated with arthroplasty instead of closed reduction of the fracture followed by internal fixation with pins or screws. Few clinical trials have addressed undisplaced or minimally displaced fractures of the femoral neck. These fractures have been associated with a good prognosis and likewise a good functional outcome. However, recent articles present far less favorable results, with high re-operation rates (10-15%), reduced function, and pain on walking after internal fixation. Indirect comparing studies, suggest that hemiarthroplasty may yield better functional outcomes and lower re-operation rates. Approximately 20% of all femoral neck fractures in patients aged 70 years or older are minimally displaced or undisplaced. Hence the investigators call for a randomised controlled trial comparing pain, function, walking ability, quality of life, re-operation rates and complications after internal fixation versus hemiarthroplasty in patients aged 70 years and older.

详细描述

The consequences of a femoral neck fracture still have a substantial impact on the individual patient´s health as well as on society. Approximately 5000 individuals suffer a fracture of the femoral neck annually in Norway. The mortality rate approximates 25% during the first year after this injury. The hospital costs of treating a single femoral neck fracture, have been estimated to 20 000 euros.

In spite of relatively well-documented treatment protocols, there is still a need for prospective randomised controlled trials to determine the optimal treatment of certain sub-groups of patients presenting with a femoral neck fracture.

Several studies with a high level of evidence have elucidated management of displaced femoral neck fractures. There is increasing evidence favouring joint replacement surgery over internal fixation when treating displaced femoral neck fractures. However, management of undisplaced and minimally displaced femoral neck fractures has received less attention.

According to the Cochrane Library, there are no randomised controlled trials comparing internal fixation to hemiarthroplasty in patients with undisplaced femoral neck fractures. Previous studies have focused mostly on fracture healing, equating fracture union and success. However, recent studies report decreased functional and life quality scores amongst patients with undisplaced femoral neck fractures treated with internal fixation. The control group in these studies consists of patients with a displaced femoral neck fracture treated with hemi - arthroplasty. Zlowodzki et al showed, by means of validated assessment scores, that patients with internally fixated undisplaced femoral neck fractures often experience shortening of the injured limb. Then again, this is associated with lower functional and life quality scores. In Rogmark´s series of patients with undisplaced femoral neck fractures treated with internal fixation, 25% patients report daily pain from the affected hip upon walking, one and a half year after surgery. Gjertsen et al analysed data for the Norwegian hip fracture registry from more than 4000 patients to demonstrate that treatment with hemiarthroplasty, due to a displaced femoral neck fracture, is associated with better function and less pain than treatment with internal fixation due to an undisplaced femoral neck fracture.

Thus, our research group will conduct a prospective randomised controlled trial to identify any differences in clinical outcome after surgical treatment of undisplaced femoral neck fractures in patients aged 70 years and older. The two methods that will be compared are internal fixation with two screws and modern modular hemiarthroplasty. The primary outcome measure is a difference of at least 10 points in Harris Hip Score (95% power, standard deviation approximates 15 points from previous Norwegian patient series). The primary follow-up length is set to two years, but a long-term follow-up five years after surgery is also planned. It is important to include the cognitively impaired patients as they account for 20-25% of the study population. Patients who cannot provide informed consent due to impaired cognitive function, are included if consent is provided by a family member or relative.

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
Single (Investigator)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 70 years or older
  • Undisplaced or minimally displaced intracapsular femoral neck fracture (Garden I/II)
  • Patient able to walk before injury (all aids allowed)
  • Patient lives within the catchment area of the three involved centres

排除标准

  • Displaced fractures (Garden III/IV) and impacted fractures with minimal varus
  • Pathologic fracture
  • Current soft tissue or deep infection in the hip or pelvis area
  • ASA IV patients as classified by the anesthesiologist on call
  • Other contraindications to either of the two methods compared
  • Temporarily impaired cognitive function:
  • (That is when the patient is judged as unable to provide an informed consent by the surgeon on call and there is no previous history of impaired cognitive function as documented by previous hospital record or a family member / proxy)

研究组 & 干预措施

Internal fixation - standard treatment

Active Comparator

Internal fixation with two parallel cancellous screws (Hip Pins(R)) Current standard treatment

干预措施: internal fixation (Device)

Hemi - arthroplasty

Experimental

cemented Hemi - arthroplasty (Exeter(R)) modular system V40 by Stryker. Refobacin cement.

干预措施: Hemi - arthroplasty (Device)

结局指标

主要结局

Change in Harris Hip Score of 10 points or more.

时间窗: Baseline prior to fracture, 3 months, 1 year and 2 years

Harris hip score - a validated outcome measure to evaluate hip fracture intervention The physiotherapist recording the Harris Hips Score after 3 months, 1 year and two years is blinded. Clinical examination of the hip is carried out with masking of proximal thigh by proper clothes.

次要结局

  • Numeric pain intensity scale (0-10)(Two weeks prior to fracture (retrospective), at discharge at an average 3-5 days after surgery, after 3 months, 1 year and 2 years)
  • Mini mental state(MMSE-NR)(3 months)
  • Euro-Quol 5 dimension (Eq5d)(Baseline prior to fracture, 3 months, 1 year and 2 years)
  • Death(5 years after surgery)
  • Hospital and society costs(at baseline prior to fracture, at discharge, 3 months, 1 year and 2 years)
  • Timed Up and Go test (TUG test)(3 months, 1 year and 2 years)
  • Reoperation rate(5 years after surgery)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip C Dolatowski

Principal Investigator

University Hospital, Akershus

研究点 (2)

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