Clinical trial NCT01515670: Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)
Official title: Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty Complications
Co-morbidity
Postoperative Morbidity
Keywords: THA
TKA
Fast-track
Enhanced recovery
preoperative co-morbidity
postoperative morbidity
Arthroplasty
Replacement
Hip
Knee
Morbidity
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Aarhus University Hospital
name: Vejle Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Regional Hospital Holstebro
name: Naestved Hospital
name: Bispebjerg Hospital
name: Central Jutland Regional Hospital
name: Aalborg University Hospital
First posted: 2012-01-24
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: unselected patients receiving THA or TKA

Brief summary: The purpose of the study is to determine the influence of preoperative co-morbidity in relation to increased length of stay and postoperative complications in patients receiving fast-track hip or knee replacement.

Detailed description: Preoperative risk assessment is well established and repeatedly demonstrated to be related to adverse postoperative outcomes regarding all organ functions. However, all evidence is based upon conventional care programs and none has been done on fast-track surgery, neither in total hip arthroplasty (THA) or total knee arthroplasty (TKA).

The purpose of this study series is therefore to evaluate the importance of conventional risk factors in an optimised fast-track TKA and THA set-up. These studies will be performed in the Lundbeck Foundation Center for fast-track THA and TKA, based on an established database, but with additional detailed risk information to be included in studies of certain types co-morbidity.

The Lundbeck Foundation Center Database prospectively registers patient characteristics and co-morbidity in all patients receiving hip and knee arthroplasty. This is done using a questionaire and with dedicated staff available to help in case of doubt regarding specific questions. Additional information is collected by scrutinizing the patients medical charts. Completeness of data has been shown to be about 95%.

Eligibility criteria: Inclusion Criteria:

* Standardized elective fast-track THA or TKA

Exclusion Criteria:

* Elective THA or TKA not in regular fast-track setup
* not a Danish citizen

Primary outcomes:
measure: Length of hospital stay and reasons for length of hospital stay >4days
timeFrame: At discharge
measure: Surgically related readmissions
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Mortality 90 days after surgery
timeFrame: 90 days after surgery
Other outcomes:
measure: Co-morbidity related readmissions
timeFrame: 90 days after surgery
Locations:
city: Farsø
country: Denmark
facility: Himmerland Hospital
state: Judland
city: Holstebro
country: Denmark
facility: Holstebro Regionalhospital
state: Judland
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Judland
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Seeland
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
city: Gentofte
country: Denmark
facility: Gentofte University Hospital
city: Næstved
country: Denmark
facility: Næstved Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christoffer C Joergensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortved M, Petersen PB, Jorgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Postoperative Morbidity and Mortality in Diabetic Patients After Fast-Track Hip and Knee Arthroplasty: A Prospective Follow-up Cohort of 36,762 Procedures. Anesth Analg. 2021 Jul 1;133(1):115-122. doi: 10.1213/ANE.0000000000005248.
citation: Jorgensen CC, Gromov K, Petersen PB, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Influence of day of surgery and prediction of LOS > 2 days after fast-track hip and knee replacement. Acta Orthop. 2021 Apr;92(2):170-175. doi: 10.1080/17453674.2020.1844946. Epub 2020 Nov 12.
citation: Petersen PB, Jorgensen CC, Kehlet H; Lundbeck Foundation Center for Fast-track Hip and Knee Replacement collaborative group. Temporal trends in length of stay and readmissions after fast-track hip and knee arthroplasty. Dan Med J. 2019 Jul;66(7):A5553.
citation: Jorgensen CC, Petersen MA, Kehlet H; Lundbeck Foundation Centre for Fast-Track Hip and Knee Replacement Collaborative Group. Preoperative prediction of potentially preventable morbidity after fast-track hip and knee arthroplasty: a detailed descriptive cohort study. BMJ Open. 2016 Jan 12;6(1):e009813. doi: 10.1136/bmjopen-2015-009813.