Clinical trial NCT03392285: Undisplaced Femoral Neck Fractures
Official title: Undisplaced Femoral Neck Fractures: Treatment With Internal Fixation or Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Femoral Neck Fractures
Undisplaced Fracture
Internal Fixation; Complications
Arthroplasty Complications
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 235
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To evaluate the potential benefit of surgery with arthroplasty. All patients treated at Sundsvall hospital, Sweden for a displaced femoral neck fracture treated with hip arthroplasty or a undisplaced femoral neck fracture treated with internal fixation were included in a prospective cohort study.

Brief summary: Purpose The purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty.

Methods In a consecutive series of patients we compared the results of internal fixation for undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures (control group) of elderly patients. Risk of reoperation and patient reported hip function assessed with Harris hip score and WOMAC were used as outcome measurements.


Eligibility criteria: Inclusion Criteria:

Above 65 years old Displaced femoral neck fracture treated with hip arthroplasty Undisplaced femoral neck fracture treated with internal fixation

Exclusion Criteria:

* Pathologic fracture

Primary outcomes:
measure: Reoperation
timeFrame: 4 years
Secondary outcomes:
measure: Harris hip score
timeFrame: 1 year postoperatively
measure: WOMAC
timeFrame: 1 year postoperatively
measure: Pain in the operated hip
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: Rogmark C, Flensburg L, Fredin H. Undisplaced femoral neck fractures--no problems? A consecutive study of 224 patients treated with internal fixation. Injury. 2009 Mar;40(3):274-6. doi: 10.1016/j.injury.2008.05.023. Epub 2008 Dec 13.
citation: Gjertsen JE, Dybvik E, Furnes O, Fevang JM, Havelin LI, Matre K, Engesaeter LB. Improved outcome after hip fracture surgery in Norway. Acta Orthop. 2017 Oct;88(5):505-511. doi: 10.1080/17453674.2017.1344456. Epub 2017 Jul 6.
citation: Han SK, Song HS, Kim R, Kang SH. Clinical results of treatment of garden type 1 and 2 femoral neck fractures in patients over 70-year old. Eur J Trauma Emerg Surg. 2016 Apr;42(2):191-6. doi: 10.1007/s00068-015-0528-6. Epub 2015 Apr 18.
citation: Chen WC, Yu SW, Tseng IC, Su JY, Tu YK, Chen WJ. Treatment of undisplaced femoral neck fractures in the elderly. J Trauma. 2005 May;58(5):1035-9; discussion 1039. doi: 10.1097/01.ta.0000169292.83048.17.
citation: Gjertsen JE, Fevang JM, Matre K, Vinje T, Engesaeter LB. Clinical outcome after undisplaced femoral neck fractures. Acta Orthop. 2011 Jun;82(3):268-74. doi: 10.3109/17453674.2011.588857.
citation: Mukka S, Sjoholm P, Aziz A, Eisler T, Kadum B, Krupic F, Morberg P, Sayed-Noor A. A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly: a pilot study for a clinical trial. Pilot Feasibility Stud. 2020 Jul 11;6:98. doi: 10.1186/s40814-020-00642-w. eCollection 2020.