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Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Hvidovre University Hospital
Aarhus University Hospital
Vejle Hospital
Sydvestjysk Hospital
Regional Hospital Holstebro
Information provided by (Responsible Party):
Christoffer Joergensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01515670
First received: January 18, 2012
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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.


Condition
Arthroplasty Complications
Co-morbidity
Postoperative Morbidity

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA).

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Length of hospital stay and reasons for length of hospital stay >4days [ Time Frame: At discharge ] [ Designated as safety issue: No ]

    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


  • Surgically related readmissions [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mortality 90 days after surgery [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]
    Evaluation of all deaths 90 days after surgery


Other Outcome Measures:
  • Co-morbidity related readmissions [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]
    Depending on the type of co-morbidity investigated, special attention and analysis of readmissions found to be related to the specific type of co-morbidity will be done


Estimated Enrollment: 30000
Study Start Date: February 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fast-track THA/TKA
Any patient receiving THA/TKA in the participating wards

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

unselected patients receiving THA or TKA

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515670

Contacts
Contact: Christoffer C Joergensen, MD +45 35454616 christoffer.calov.joergensen@rh.regionh.dk
Contact: Henrik Kehlet, Prof,MD,PhD +45 35454074 henrik.kehlet@rh.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Judland, Denmark, 8000
Himmerland Hospital Recruiting
Farsoe, Judland, Denmark, 9640
Sydvestjydsk hospital Grindsted Recruiting
Grindsted, Judland, Denmark, 7200
Holstebro Regionalhospital Recruiting
Holstebro, Judland, Denmark, 7500
Vejle Hospital Recruiting
Vejle, Judland, Denmark, 7100
Viborg Hospital Recruiting
Viborg, Judland, Denmark, 8800
Contact: Andrea Søe-Larsen, Nurse       andrsoee@rm.dk   
Principal Investigator: Niels Krarup, MD         
Hvidovre Hospital Recruiting
Hvidovre, Seeland, Denmark, 2650
Bispebjerg University Hospital Recruiting
Copenhagen, Denmark
Contact: Jens Bagger, MD       Jens.Bagger@regionh.dk   
Gentofte University Hospital Recruiting
Gentofte, Denmark
Contact: Søren Solgaard, MD         
Principal Investigator: Søren Solgaard, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Hvidovre University Hospital
Aarhus University Hospital
Vejle Hospital
Sydvestjysk Hospital
Regional Hospital Holstebro
Investigators
Principal Investigator: Christoffer C Joergensen, MD Rigshospitalet, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: Christoffer Joergensen, Research-fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01515670     History of Changes
Other Study ID Numbers: RH30-0623
Study First Received: January 18, 2012
Last Updated: November 4, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
THA
TKA
Fast-track
Enhanced recovery
preoperative co-morbidity
postoperative morbidity
Arthroplasty
Replacement
Hip
Knee
Morbidity

ClinicalTrials.gov processed this record on November 27, 2014