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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01515670

Collaborator

Hvidovre University Hospital (Other), Aarhus University Hospital (Other), Vejle Hospital (Other), Sydvestjysk Hospital (Other), Regional Hospital Holstebro (Other), Naestved Hospital (Other), Bispebjerg Hospital (Other), Central Jutland Regional Hospital (Other), Aalborg University Hospital (Other)

60,000

Enrollment

Locations

107

Actual Duration (Months)

8571.4

Patients Per Site

80.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty Complications Co-morbidity Postoperative Morbidity

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%.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Fast-track THA/TKA Any patient receiving THA/TKA in the participating wards

Outcome Measures

Primary Outcome Measures

Length of hospital stay and reasons for length of hospital stay >4days [At discharge]
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 [90 days after surgery]
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 [90 days after surgery]
Evaluation of all deaths 90 days after surgery

Other Outcome Measures

Co-morbidity related readmissions [90 days after surgery]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Himmerland Hospital	Farsø	Judland	Denmark	9640
2	Holstebro Regionalhospital	Holstebro	Judland	Denmark	7500
3	Vejle Hospital	Vejle	Judland	Denmark	7100
4	Hvidovre Hospital	Hvidovre	Seeland	Denmark	2650
5	Bispebjerg University Hospital	Copenhagen		Denmark
6	Gentofte University Hospital	Gentofte		Denmark
7	Næstved Hospital	Næstved		Denmark