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

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515670
• Other study ID #: RH30-0623
• Status: Completed
• Start date: February 2010
• Est. completion date: January 2019

Study information

• Verified date: June 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60000
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Co-morbidity
• Postoperative Morbidity

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen
Denmark	Himmerland Hospital	Farsø	Judland
Denmark	Gentofte University Hospital	Gentofte
Denmark	Holstebro Regionalhospital	Holstebro	Judland
Denmark	Hvidovre Hospital	Hvidovre	Seeland
Denmark	Næstved Hospital	Næstved
Denmark	Vejle Hospital	Vejle	Judland

Sponsors (10)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Central Jutland Regional Hospital, Hvidovre University Hospital, Naestved Hospital, Regional Hospital Holstebro, Sydvestjysk Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Co-morbidity related readmissions	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	90 days after surgery
Primary	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
Primary	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	Mortality 90 days after surgery	Evaluation of all deaths 90 days after surgery	90 days after surgery

External Links

•   The Lundbeck Center for Fast-track Hip and Knee replacement