Postoperative Anemia and Functional Outcomes After Fast-t... | NCT01514006

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

NCT01514006

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Mar 9, 2015Estimated

Enrollment

125Estimated

Phase

Not provided

Conditions

Arthroplasty, Hip Replacement
Anemia

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jan 17, 2012

First Submission Date that Met QC Criteria

Jan 19, 2012

First Posted Date

Jan 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2015

Last Update Posted Date

Mar 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oeivind Jans, MD., Research Fellow, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Name	Class
University Hospital, Gentofte, Copenhagen	OTHER
Vejle Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Cohort		Patients, aged 65 or above, undergoing elective primary unilateral hip arthroplasty in a fast-track setting.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

All patients aged 65 or above undergoing primary hip arhtroplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oeivind Jans, MD.	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte Hospital, Department of orthopedic surgery		Gentofte Municipality			Denmark
Vejle Sygehus, Department of orthopedic surgery

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

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Browse Branches

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