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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02137655
Other study ID # H-3-2014-005
Secondary ID
Status Completed
Phase N/A
First received May 12, 2014
Last updated March 8, 2016
Start date May 2014
Est. completion date February 2016

Study information

Verified date March 2016
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denamrk: The regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

The development and implementation of "fast-track" principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. This without a concomitant increase in morbidity or readmissions for medical or surgical complications and with reduced mortality. However, only little is known about function in the subacute period after arthroplasty, and there is a need for further data on physical and psychological functioning following discharge from hospital.This to ensure, that the positive results from the perioperative setting are carried forward in the subacute phase.


Description:

Data will be published in three papers:

1. "Physical function and related factors following discharge from THA and TKA" Luna IE, Kehlet H, Aasvang EK.

2. "Postoperative hypoxemia following fast-track hip and knee arthroplasty" Luna IE, Kehlet H, Aasvang EK.

3. "Cognitive dysfunction after fast-track hip- and knee arthroplasty - prevalence and related factors". Luna IE, Kehlet H, Aasvang EK.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 55 Years to 75 Years
Eligibility Inclusion Criteria:

- Primary total hip or knee arthroplasty

- Age 55 to 80 years

Exclusion Criteria:

- Deficient written or spoken danish

- Alcohol abuse (>21 U per week)

- Immunocompromised

- Anticoagulant therapy

- ASA class 4-5

- Functional impairment from psychological or neurological disease

- Sleepapnea

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Gentofte hospital Gentofte Region hovedstaden
Denmark Vejle Sygehus Vejle Region syd

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain VAS when walking 48 hours postoperatively No
See also
  Status Clinical Trial Phase
Terminated NCT00522080 - Screening for Hip and Knee Osteoarthritis in the General Population: Predictive Value of a Questionnaire and Prevalence Estimates N/A
Completed NCT01601951 - Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis N/A