NCT01514006

Brief Summary

The purpose of this study is to evaluate the possible association between postoperative anaemia and functional outcomes the first 2 weeks after primary hip arthroplasty. The investigators hypothesise that patients with a higher degree of postoperative anaemia have impaired postoperative rehabilitation as measured by standardized functional outcome tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

January 17, 2012

Last Update Submit

March 6, 2015

Conditions

Arthroplasty, Hip ReplacementAnemia

Keywords

Primary hip arthroplastypostoperative anemiafunctional outcomes

Outcome Measures

Primary Outcomes (1)

  • 6 Minute walking test (6MWT)

    6MWT is a standardized functional test which determines the walking distance covered during a timed period of 6 minutes.

    2 weeks after surgery

Secondary Outcomes (3)

  • FACT-Anemia Scale

    2 weeks after surgery

  • Timed up and go test (TUG)

    2 weeks after surgery

  • At home activity by ActivPal

    1 week after surgery

Study Arms (1)

Study Cohort

Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 65 or above undergoing primary hip arhtroplasty

You may qualify if:

  • Patients undergoing primary unilateral THA
  • Age 65 or older

You may not qualify if:

  • Not able to give consent
  • Not able to walk prior to surgery
  • Chronic need for RBC transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gentofte Hospital, Department of orthopedic surgery

Gentofte Municipality, Denmark

Location

Vejle Sygehus, Department of orthopedic surgery

Vejle, Denmark

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Oeivind Jans, MD.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

DK(2)