Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)
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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). |
- Length of hospital stay [ Time Frame: At discharge ] [ Designated as safety issue: No ]Number of nights spend in hospital after day of surgery, including transferral between departments.
- 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
| 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 |
unselected patients receiving THA or TKA
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| 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 |
| 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 | |
| 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: | February 5, 2013 |
| 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 |
Additional relevant MeSH terms:
|
Tacrine Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents |
Physiological Effects of Drugs Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013