NCT02771639

Brief Summary

Introduction Periprosthetic joint infection (PJI) is a severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Few studies have evaluated the outcome of DAIR in this fragile population.The purpose of this study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with a hip arthroplasty. Methods A consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were retrospective analysed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
736

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 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, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

May 8, 2016

Last Update Submit

May 12, 2016

Conditions

Keywords

Hip arthroplastyperiprosthetic joint infectionoutcome

Outcome Measures

Primary Outcomes (1)

  • Rate of periprosthetic joint infection

    The incidence of periprosthetic joint infection

    1 year

Secondary Outcomes (1)

  • The rate of healed periprosthetic joint infections after treatment with surgical debridement.

    6 months

Study Arms (1)

Femoral neck fractures

Patients admitted to Sundsvall hospital for a displaced femoral neck fracture and treated with a hip arthroplasty

Procedure: Hip arthroplasty

Interventions

Treatment with a hip arthroplasty (semi- or total hip arthroplasty) for a displaced femoral neck fracture

Femoral neck fractures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with a hip arthroplasty for a displaced femoral neck fracture at Sundsvall hospital, Sweden between 2006 and 2015. All patients were included.

You may qualify if:

  • Displaced femoral neck fracture
  • Treated with a primary hip arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):1-10. doi: 10.1093/cid/cis966.

    PMID: 23230301BACKGROUND
  • Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.

    PMID: 23083433BACKGROUND
  • Edwards C, Counsell A, Boulton C, Moran CG. Early infection after hip fracture surgery: risk factors, costs and outcome. J Bone Joint Surg Br. 2008 Jun;90(6):770-7. doi: 10.1302/0301-620X.90B6.20194.

    PMID: 18539671BACKGROUND
  • Fisman DN, Reilly DT, Karchmer AW, Goldie SJ. Clinical effectiveness and cost-effectiveness of 2 management strategies for infected total hip arthroplasty in the elderly. Clin Infect Dis. 2001 Feb 1;32(3):419-30. doi: 10.1086/318502. Epub 2001 Jan 26.

    PMID: 11170950BACKGROUND
  • Noailles T, Brulefert K, Chalopin A, Longis PM, Gouin F. What are the risk factors for post-operative infection after hip hemiarthroplasty? Systematic review of literature. Int Orthop. 2016 Sep;40(9):1843-8. doi: 10.1007/s00264-015-3033-y. Epub 2015 Nov 27.

    PMID: 26611729BACKGROUND

MeSH Terms

Conditions

Femoral Neck FracturesInfections

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Sebastian Mukka, M.D, Ph.D

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 8, 2016

First Posted

May 13, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05