Complications and Functional Outcome of Displaced Femoral Neck Fractures in Patients Younger Than 70 Years
- Introduction : Patients younger than 70 years with a displaced femoral neck are in serious conditions. The femoral neck fracture (FNF) is associated with low activity levels, hip pain and substantially reduced quality of life (QoL). Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced FNFs are in patients aged 55 - 70 years. 3535 patients aged 55 - 70 years were registered in the Norwegian Arthroplasty Registry and in the Norwegian Hip Fracture Registry in the period 2005 - 2012. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment and the health economic aspect a great challenge. In this study the investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy FNF treated with a total hip arthroplasty (THA) leads to a better functional outcome than osteosynthesis (stabilization by use of hip pins) and can patient-related factors be identified that predispose for FNF?
- Background : Displaced low - energy FNF in patients aged 55 - 70 years is usually treated with osteosynthesis or implantation of a prosthesis. For patients older than 70 years, several randomized studies compare THA with other treatment options; the studies have not found a higher mortality or morbidity for THA. Most orthopedics would probably recommend a closed reposition and osteosynthesis for patients younger than 60 years. Screw fixation procedures will often be of shorter duration and less invasive, but the risk of needing a new operation because of a failure is higher than with prosthetic surgery. With a reoperation the risk of complications is higher than with the first operation. How this affects mortality, morbidity and functional outcome in this patient group is uncertain. Studies have shown both lower morbidity and earlier mortality than with prosthetic surgery. On the other hand the reoperation rate because of failed osteosynthesis is 28 - 42% versus about 10% for THA; more recent studies show a reoperation rate for THA of 5%. Young patients with low - energy FNF often have other diseases and conditions that may increase the risk of failed osteosynthesis. Reasons may be use of medication (steroids, epilepsy medication), alcoholism or other types of substance abuse and presence of risk factors for osteoporosis. Several review articles and meta - analyses conclude that THA is associated with a lower rate of complications and a better functional outcome than other treatment alternatives.
Goals for the project:
Map patient - related factors that predispose for displaced FNF for patients aged 55 - 70 years.
Map bone density measured with Dexa for two types of surgical procedures. Map complications and functional outcome after osteosynthesis (with 2 screws) or THA in patients aged 55 - 70 years with displaced FNF.
- Study procedures: It is a randomized multi center study of patients operated with either THA or osteosynthesis (with 2 screws) in which functional outcome, complications and reoperations are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and possibly after 3, 5, 10, 15 and 20 years.
Displaced Femoral Neck Fractures
Procedure: Total hip replacement arthroplasty
Procedure: Closed reduction and internal fixation
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Complications and Functional Outcome of Displaced Femoral Neck Fractures Treated With Internal Fixation vs Total Hip Arthroplasty in Patients Younger Than 70 Years. A Randomized Controlled Double Blind Multi Center Trial.|
- Harris Hip score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: 4 months and 2 years ] [ Designated as safety issue: Yes ]
- QoL questionnaire (EQ-5D) [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]Measure of health status from the EuroQol
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS) [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
- VAS [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
- Complications [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: Yes ]
Incidence of complications. General complications, f.ex: urinary tract infections, venous thrombosis, pulmonary embolism, pneumonia, mortality.
Per- and postoperative complications related to method, f.ex: fracture of the femur, bleeding, cut- out, caput necrosis, infection, luxation, periprosthetic fracture, component loosening.
- Reoperation [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
- Morbidity [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: Yes ]
- Charlson comorbidity index [ Time Frame: 4 and 12 months, 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Total hip replacement arthroplasty
59 off 118 patients will be randomized to total hip replacement arthroplasty
|Procedure: Total hip replacement arthroplasty|
Active Comparator: Closed reduction and internal fixation
59 off 118 patients will be randomized to closed reduction and internal fixation.
2 cancellous parallel hip pins
|Procedure: Closed reduction and internal fixation|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02085707
|Contact: Stefan Bartels, MD||91502900 ext firstname.lastname@example.org|
|Contact: Stein Erik Utvåg, PhD||91502900 ext email@example.com|
|Vestre Viken HF||Not yet recruiting|
|Bærum, Akershus, Norway, 1346|
|Contact: Wender Figved, PhD 91503525 ext 0047|
|Principal Investigator: Wender Figved, PhD|
|University Hospital, Akershus||Recruiting|
|Lørenskog, Akershus, Norway, 1478|
|Contact: Stefan Bartels, MD 91502900 ext 0047 firstname.lastname@example.org|
|Haukeland University Hospital||Not yet recruiting|
|Bergen, Hordaland, Norway, 5021|
|Contact: Jan- Erik Gjertsen, PhD 55985000 ext 0047|
|Principal Investigator: Jan-Erik Gjertsen, PhD|
|Ullevaal University Hospital||Not yet recruiting|
|Oslo, Norway, 0450|
|Contact: Frede Frihagen, PhD 22118080 ext 0047|
|Principal Investigator: Frede Frihagen, PhD|
|Principal Investigator:||Torbjørn Omland, Professor||University Hospital, Akershus|