NCT01089946

Brief Summary

The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

March 17, 2010

Last Update Submit

October 9, 2012

Conditions

Arthroplasty

Keywords

MobilizationHip arthroplastycardiovascular

Outcome Measures

Primary Outcomes (1)

  • Orthostatic intolerance

    6 and 24 hours postoperative

Secondary Outcomes (1)

  • Orthostatic hypotension

    6 and 24 hours postoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing primary THA.

You may qualify if:

  • Age \> 18 years
  • Primary THA

You may not qualify if:

  • Alcoholism
  • Known orthostatic hypotension
  • Daily use of anxiolytic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hørsholm Hospital

Hørsholm, Denmark

Location

Related Publications (2)

  • Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.

    PMID: 22174345RESULT

  • Jans O, Brinth L, Kehlet H, Mehlsen J. Decreased heart rate variability responses during early postoperative mobilization--an observational study. BMC Anesthesiol. 2015 Aug 22;15:120. doi: 10.1186/s12871-015-0099-4.

    PMID: 26297144DERIVED

Study Officials

  • Oeivind Jans, M.D.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Research Fellow

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 19, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

DK(1)