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

Completed

• Conditions: Arthroplasty, Hip Replacement; Anemia

• Registration Number: NCT01514006
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Vejle Sygehus, Department of orthopedic surgery; 🇩🇰 Vejle, Denmark

Gentofte Hospital, Department of orthopedic surgery; 🇩🇰 Gentofte, Denmark