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Completed

NCT Number: NCT01514006

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gentofte Hospital, Department of orthopedic surgery, Gentofte Municipality, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. FACT-Anemia Scale

    Time frame: 2 weeks after surgery

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

  2. Timed up and go test (TUG)

    Time frame: 2 weeks after surgery

  3. At home activity by ActivPal

    Time frame: 1 week after surgery

    Activity measures using accelerometer based activity monitor

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University Hospital, Gentofte, Copenhagen
  • Vejle Hospital

Registry information

Official study title

Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2012
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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