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Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514006
First Posted: January 20, 2012
Last Update Posted: March 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Hospital, Gentofte, Copenhagen
Vejle Hospital
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
  Purpose

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.


Condition
Arthroplasty, Hip Replacement Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Oeivind Jans, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 6 Minute walking test (6MWT) [ Time Frame: 2 weeks after surgery ]
    6MWT is a standardized functional test which determines the walking distance covered during a timed period of 6 minutes.


Secondary Outcome Measures:
  • FACT-Anemia Scale [ Time Frame: 2 weeks after surgery ]
    FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.

  • Timed up and go test (TUG) [ Time Frame: 2 weeks after surgery ]
  • At home activity by ActivPal [ Time Frame: 1 week after surgery ]
    Activity measures using accelerometer based activity monitor


Estimated Enrollment: 125
Study Start Date: January 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Cohort
Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting.

Detailed Description:

Postoperative anemia may impair postoperative rehabilitation due to anemia related symptoms such as fatigue or dizziness. Although, the impact of postoperative anemia on postoperative rehabilitation and function has previously been examined the results are conflicting.

Patients undergoing fast-track hip arthroplasty (THA) are mobilized early and participate in physiotherapy during the admission but are discharged early (2-3) days postoperative. However, the ability to rehabilitate early after discharge has not been evaluated in relation to postoperative anemia.

The purpose of this observational 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. Hb concentrations and functional outcome measurements will be performed preoperatively, at the day of hospital discharge and during a postoperative visit 12-16 days after surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients aged 65 or above undergoing primary hip arhtroplasty
Criteria

Inclusion Criteria:

  • Patients undergoing primary unilateral THA
  • Age 65 or older

Exclusion Criteria:

  • Not able to give consent
  • Not able to walk prior to surgery
  • Chronic need for RBC transfusion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514006


Locations
Denmark
Gentofte Hospital, Department of orthopedic surgery
Gentofte, Denmark
Vejle Sygehus, Department of orthopedic surgery
Vejle, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Vejle Hospital
Investigators
Principal Investigator: Oeivind Jans, MD. Rigshospitalet, Denmark
  More Information

Responsible Party: Oeivind Jans, MD., Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01514006     History of Changes
Other Study ID Numbers: H-4-2011-117
First Submitted: January 17, 2012
First Posted: January 20, 2012
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by Oeivind Jans, Rigshospitalet, Denmark:
Primary hip arthroplasty
postoperative anemia
functional outcomes

Additional relevant MeSH terms:
Anemia
Hematologic Diseases