Undisplaced Femoral Neck Fractures

Hip Fractures Clinical Trial

— UNFNF  

Official title:

Undisplaced Femoral Neck Fractures: Treatment With Internal Fixation or Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392285
• Other study ID #: UFNF_IFvsHA
• Status: Completed
• Phase: N/A
• First received: January 1, 2018
• Last updated: January 1, 2018
• Start date: January 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 31, 2017
• Est. primary completion date: May 31, 2015
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures
• Internal Fixation; Complications
• Undisplaced Fracture

Intervention

Device:
• Internal fixation or hip arthroplasty
Patients treated according to the routine at the orthopedic department with screw fixation of an undisplayed femoral neck fracture or hip arthroplasty for a displaced femoral neck fracture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (5)

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. — View Citation

Gjertsen JE, Dybvik E, Furnes O, Fevang JM, Havelin LI, Matre K, Engesæter 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. — View Citation

Gjertsen JE, Fevang JM, Matre K, Vinje T, Engesæter LB. Clinical outcome after undisplaced femoral neck fractures. Acta Orthop. 2011 Jun;82(3):268-74. doi: 10.3109/17453674.2011.588857. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Reapportions are recorded and compared between the groups.	4 years
Secondary	Harris hip score	Patient reported outcome (0-100 points) for evaluation of hip function.	1 year postoperatively
Secondary	WOMAC	Patient reported outcome (0-96 points) for evaluation of hip function.	1 year postoperatively
Secondary	Pain in the operated hip	Estimated with pain numeric rating scale (PNRS). Grading 0-10.	1 year postoperatively