Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)
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.
|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).|
- 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
- Mortality 90 days after surgery [ Time Frame: 90 days after surgery ] [ Designated as safety issue: No ]Evaluation of all deaths 90 days after surgery
- 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
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Any patient receiving THA/TKA in the participating wards
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515670
|Contact: Christoffer C Joergensen, MD||+45 firstname.lastname@example.org|
|Contact: Henrik Kehlet, Prof,MD,PhD||+45 email@example.com|
|Aarhus University Hospital||Recruiting|
|Aarhus, Judland, Denmark, 8000|
|Farsoe, Judland, Denmark, 9640|
|Sydvestjydsk hospital Grindsted||Recruiting|
|Grindsted, Judland, Denmark, 7200|
|Holstebro, Judland, Denmark, 7500|
|Vejle, Judland, Denmark, 7100|
|Viborg, Judland, Denmark, 8800|
|Contact: Andrea Søe-Larsen, Nurse firstname.lastname@example.org|
|Principal Investigator: Niels Krarup, MD|
|Hvidovre, Seeland, Denmark, 2650|
|Bispebjerg University Hospital||Recruiting|
|Contact: Jens Bagger, MD Jens.Bagger@regionh.dk|
|Gentofte University Hospital||Recruiting|
|Contact: Søren Solgaard, MD|
|Principal Investigator: Søren Solgaard, MD|
|Principal Investigator:||Christoffer C Joergensen, MD||Rigshospitalet, Denmark|