Text Size

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

This study is currently recruiting participants.
Verified September 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Vejle Hospital
Information provided by (Responsible Party):
Oeivind Jans, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01514006
First received: January 17, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  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:

MedlinePlus related topics: Anemia
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 6 Minute walking test (6MWT) [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.


Estimated Enrollment: 125
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514006

Contacts
Contact: Oeivind Jans, MD. +4535451631 oeivind.jans@rh.regionh.dk

Locations
Denmark
Gentofte Hospital, Department of orthopedic surgery Recruiting
Gentofte, Denmark
Contact: Søren Solgaard, MD            
Principal Investigator: Søren Solgaard, MD            
Vejle Sygehus, Department of orthopedic surgery Recruiting
Vejle, Denmark
Contact: Per K Andersen            
Principal Investigator: Per K Andersen, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Vejle Hospital
Investigators
Principal Investigator: Oeivind Jans, MD. Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Oeivind Jans, MD., Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01514006     History of Changes
Other Study ID Numbers: H-4-2011-117
Study First Received: January 17, 2012
Last Updated: September 12, 2012
Health Authority: Denmark: The scientific ethical commitee for the capital region of Denmark

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013