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Arthroplasty ComplicationsNCT01515670

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

An observational study of Arthroplasty Complications and Co-morbidity, run by Copenhagen University Hospital, Rigshospitalet at 7 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
60,000 participants
Where
7 sitesDenmark
Study dates
Feb 2010to Jan 2019
How long will I take part?
90 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: unselected patients receiving THA or TKA

Who may be able to join

  • Standardized elective fast-track THA or TKA

Who cannot join

  • Elective THA or TKA not in regular fast-track setup
  • not a Danish citizen

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Denmark7 sites

  • Bispebjerg University Hospital

    Copenhagen

  • Himmerland Hospital

    Farsø, Judland, 9640

  • Gentofte University Hospital

    Gentofte Municipality

  • Holstebro Regionalhospital

    Holstebro, Judland, 7500

  • Hvidovre Hospital

    Hvidovre, Region Sjælland, 2650

  • Næstved Hospital

    Næstved

  • Vejle Hospital

    Vejle, Judland, 7100

Other trials in Denmark

About this study

Official title: 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.

Read the 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%.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01515670
Study groupRoleWhat they receive
Fast-track THA/TKAAny patient receiving THA/TKA in the participating wards

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At discharge

  2. 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

    Measured: 90 days after surgery

Secondary outcomes (1)

  1. Mortality 90 days after surgery

    Evaluation of all deaths 90 days after surgery

    Measured: 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startFeb 2010
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60,000 participants (actual)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515670
Sponsor's protocol ID
RH30-0623
Status last verified
Jun 2021
First submitted
18 Jan 2012
Last updated
22 Jun 2021
Results posted
No
Data monitoring committee
No

Publications

  • Ortved M, Petersen PB, Jorgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Postoperative Morbidity and Mortality in Diabetic Patients After Fast-Track Hip and Knee Arthroplasty: A Prospective Follow-up Cohort of 36,762 Procedures. Anesth Analg. 2021 Jul 1;133(1):115-122. doi: 10.1213/ANE.0000000000005248.

    PubMed 33234944

  • Jorgensen CC, Gromov K, Petersen PB, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Influence of day of surgery and prediction of LOS > 2 days after fast-track hip and knee replacement. Acta Orthop. 2021 Apr;92(2):170-175. doi: 10.1080/17453674.2020.1844946. Epub 2020 Nov 12.

    PubMed 33176546

  • Petersen PB, Jorgensen CC, Kehlet H; Lundbeck Foundation Center for Fast-track Hip and Knee Replacement collaborative group. Temporal trends in length of stay and readmissions after fast-track hip and knee arthroplasty. Dan Med J. 2019 Jul;66(7):A5553.

    PubMed 31256778

  • Jorgensen CC, Petersen MA, Kehlet H; Lundbeck Foundation Centre for Fast-Track Hip and Knee Replacement Collaborative Group. Preoperative prediction of potentially preventable morbidity after fast-track hip and knee arthroplasty: a detailed descriptive cohort study. BMJ Open. 2016 Jan 12;6(1):e009813. doi: 10.1136/bmjopen-2015-009813.

    PubMed 26758264

Questions about this trial

What is this clinical trial studying?

An observational study of Arthroplasty Complications and Co-morbidity, run by Copenhagen University Hospital, Rigshospitalet at 7 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of hospital stay and reasons for length of hospital stay >4days (time frame: At discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01515670, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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