NCT03392285

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

January 1, 2018

Last Update Submit

January 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reoperation

    Reapportions are recorded and compared between the groups.

    4 years

Secondary Outcomes (3)

  • Harris hip score

    1 year postoperatively

  • WOMAC

    1 year postoperatively

  • Pain in the operated hip

    1 year postoperatively

Study Arms (2)

Internal fixation

Patients above 65years old with an undisplaced femoral neck fractures treated with primary internal fixation with screws.

Device: Internal fixation or hip arthroplasty

Hip arthroplasty

Patients above 65years old with a displaced femoral neck fractures treated with primary hip arthroplasty.

Device: Internal fixation or hip arthroplasty

Interventions

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.

Hip arthroplastyInternal fixation

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Pathologic fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 19070851BACKGROUND
  • 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.

    PMID: 28681677BACKGROUND
  • 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.

    PMID: 26038046BACKGROUND
  • 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.

    PMID: 15920421BACKGROUND
  • 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.

    PMID: 21619501BACKGROUND
  • 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.

MeSH Terms

Conditions

Hip FracturesFemoral Neck Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 5, 2018

Study Start

January 1, 2013

Primary Completion

May 31, 2015

Study Completion

December 31, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

If researchers requests data - anonymous data will be shared.