Clinical trial NCT01514006: Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty
Official title: Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Hip Replacement
Anemia
Keywords: Primary hip arthroplasty
postoperative anemia
functional outcomes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: Vejle Hospital
First posted: 2012-01-20
Enrollment: 125
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 65 or above undergoing primary hip arhtroplasty

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.

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 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

Primary outcomes:
measure: 6 Minute walking test (6MWT)
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: FACT-Anemia Scale
timeFrame: 2 weeks after surgery
measure: Timed up and go test (TUG)
timeFrame: 2 weeks after surgery
measure: At home activity by ActivPal
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital, Department of orthopedic surgery
city: Vejle
country: Denmark
facility: Vejle Sygehus, Department of orthopedic surgery
Study officials:
affiliation: Rigshospitalet, Denmark
name: Oeivind Jans, MD.
role: PRINCIPAL_INVESTIGATOR
References: