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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Arthroplasty, Hip Replacement

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 Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark
    • Gentofte Hospital, Department of orthopedic surgery
  • Vejle, Denmark
    • Vejle Sygehus, Department of orthopedic surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients aged 65 or above undergoing primary hip arhtroplasty

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Cohort; Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute walking test (6MWT)	6MWT is a standardized functional test which determines the walking distance covered during a timed period of 6 minutes.	2 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACT-Anemia Scale	FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.	2 weeks after surgery
Timed up and go test (TUG)		2 weeks after surgery
At home activity by ActivPal	Activity measures using accelerometer based activity monitor	1 week after surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Vejle Hospital; University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Oeivind Jans, MD., Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: postoperative anemia; Primary hip arthroplasty; functional outcomes
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: H-4-2011-117