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Completed

NCT Number: NCT01515670

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.

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Key information

Conditions

Arthroplasty Complications Co-morbidity Postoperative Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Himmerland Hospital, Farsø, Judland, Denmark

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About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Length of hospital stay and reasons for length of hospital stay >4days

    Time frame: 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

  2. Surgically related readmissions

    Time frame: 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 outcomes

  1. Mortality 90 days after surgery

    Time frame: 90 days after surgery

    Evaluation of all deaths 90 days after surgery

Other outcomes

  1. Co-morbidity related readmissions

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Bispebjerg Hospital
  • Central Jutland Regional Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Hvidovre University Hospital
  • Naestved Hospital
  • Regional Hospital Holstebro
  • Vejle Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2012
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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