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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514006
• Other study ID #: H-4-2011-117
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: March 6, 2015
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The scientific ethical commitee for the capital region of Denmark
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Arthroplasty, Hip Replacement

Locations

Country	Name	City	State
Denmark	Gentofte Hospital, Department of orthopedic surgery	Gentofte
Denmark	Vejle Sygehus, Department of orthopedic surgery	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University Hospital, Gentofte, Copenhagen, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	FACT-Anemia Scale	FACT-Anemia scale is a validated questionare based score addressing anaemia related symptoms.	2 weeks after surgery	No
Secondary	Timed up and go test (TUG)		2 weeks after surgery	No
Secondary	At home activity by ActivPal	Activity measures using accelerometer based activity monitor	1 week after surgery	No