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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01514006
Collaborator
University Hospital, Gentofte, Copenhagen (Other), Vejle Hospital (Other)
125
Enrollment
2
Locations
19
Duration (Months)
62.5
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    125 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Study Cohort

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

    Outcome Measures

    Primary Outcome Measures

    1. 6 Minute walking test (6MWT) [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

    1. FACT-Anemia Scale [2 weeks after surgery]

      FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.

    2. Timed up and go test (TUG) [2 weeks after surgery]

    3. At home activity by ActivPal [1 week after surgery]

      Activity measures using accelerometer based activity monitor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Gentofte Hospital, Department of orthopedic surgery Gentofte Denmark
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oeivind Jans, MD., Research Fellow, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT01514006
    Other Study ID Numbers:
    • H-4-2011-117
    First Posted:
    Jan 20, 2012
    Last Update Posted:
    Mar 9, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Oeivind Jans, MD., Research Fellow, Rigshospitalet, Denmark
    Primary hip arthroplasty
    postoperative anemia
    functional outcomes
    Additional relevant MeSH terms:
    Anemia

    Study Results

    No Results Posted as of Mar 9, 2015