NCT01515670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

8.9 years

First QC Date

January 18, 2012

Last Update Submit

June 20, 2021

Conditions

Keywords

THATKAFast-trackEnhanced recoverypreoperative co-morbiditypostoperative morbidityArthroplastyReplacementHipKneeMorbidity

Outcome Measures

Primary Outcomes (2)

  • Length of hospital stay and reasons for length of hospital stay >4days

    Number of nights spend in hospital after day of surgery, including transferral between departments. Any procedure followed by more than 4 days in hospital will have review of discharge papers to determine causes of the "prolonged" admission

    At discharge

  • Surgically related readmissions

    Evaluation of any potentially surgery related readmission 90 days after discharge. Readmissions defined as related are defined as: Revision due to prosthesis problems, deep venous thrombosis (DVT), pulmonary embolism (PE) (verified or disproved), stroke/transitory cerebral ischaemia (TCI), possible wound infection (return to operating theatre, treatment with antibiotics only, no treatment), fractures without known trauma, falls, knee manipulation, hip dislocation, cardiac problems (acute myocardial infarction (AMI), any type of arrhythmia), pneumonia, urinary retention (UR), abdominal complications (gastric ulcer, ileus) and sequelae (rehabilitation, opioid side-effects, pain, other conditions related to surgery). Readmissions due to chronic obstructive lung disease (COPD), syncope and urinary tract infection (UTI) ≤ 30 days of primary admission

    90 days after surgery

Secondary Outcomes (1)

  • Mortality 90 days after surgery

    90 days after surgery

Other Outcomes (1)

  • Co-morbidity related readmissions

    90 days after surgery

Study Arms (1)

Fast-track THA/TKA

Any patient receiving THA/TKA in the participating wards

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

unselected patients receiving THA or TKA

You may qualify if:

  • Standardized elective fast-track THA or TKA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Himmerland Hospital

Farsø, Judland, 9640, Denmark

Location

Holstebro Regionalhospital

Holstebro, Judland, 7500, Denmark

Location

Vejle Hospital

Vejle, Judland, 7100, Denmark

Location

Hvidovre Hospital

Hvidovre, Region Sjælland, 2650, Denmark

Location

Bispebjerg University Hospital

Copenhagen, Denmark

Location

Gentofte University Hospital

Gentofte Municipality, Denmark

Location

Næstved Hospital

Næstved, Denmark

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Christoffer C Joergensen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research-fellow

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

February 1, 2010

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations