Have you or your loved ones been diagnosed with arthroplasty complications?

You may be eligible to participate in a arthroplasty complications clinical trial.

Have you or your loved ones been diagnosed with arthroplasty complications? You may be eligible to participate in a arthroplasty complications clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Arthroplasty Complications Clinical Trial in Grindsted Judland

NCT01515670 | Observational patient registry

Have you or your loved ones been diagnosed with arthroplasty complications?

You may be eligible to participate in a arthroplasty complications clinical trial.

Have you or your loved ones been diagnosed with arthroplasty complications? You may be eligible to participate in a arthroplasty complications clinical trial.

Completed

Male & Female

18 Years +

This study has recruited 60000 Participants

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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Details for the study

Population

unselected patients receiving THA or TKA

Brief Title

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

Official Title

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

Brief Summary

The purpose of the study is to determine the influence of preoperative co-morbidity in <br /> relation to increased length of stay and postoperative complications in patients receiving <br /> 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%.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

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

Study Criteria

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