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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01515670
Enrollment
60000
Registered
2012-01-24
Start date
2010-02-28
Completion date
2019-01-31
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty Complications, Co-morbidity, Postoperative Morbidity

Keywords

THA, TKA, Fast-track, Enhanced recovery, preoperative co-morbidity, postoperative morbidity, Arthroplasty, Replacement, Hip, Knee, Morbidity

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.

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%.

Interventions

None listed

Sponsors

Hvidovre University Hospital
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Vejle Hospital
CollaboratorOTHER
Esbjerg Hospital - University Hospital of Southern Denmark
CollaboratorOTHER
Regional Hospital Holstebro
CollaboratorOTHER
Naestved Hospital
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER
Central Jutland Regional Hospital
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stay and reasons for length of hospital stay >4daysAt dischargeNumber 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 readmissions90 days after surgeryEvaluation 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

MeasureTime frameDescription
Mortality 90 days after surgery90 days after surgeryEvaluation of all deaths 90 days after surgery

Other

MeasureTime frameDescription
Co-morbidity related readmissions90 days after surgeryDepending 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026