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Hip OsteoarthritisNCT03183583

Tissue Adhesive in Hip and Knee Arthroplasty, A Cost -Effectiveness Analysis

An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by Amphia Hospital at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prolonged wound drainage after total hip or knee arthroplasty is a very undesirable complication, both from medical as patients view. Wound drainage prolongs hospital admission and is associated with an increased risk of infection (1) post-operative wound drainage of more than 48 hours is associated with an increased… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Osteoarthritis, Knee Osteoarthritis
What is being tested?
Tissue adhesive in primary Total Hip and Total Knee arthroplasty
Type of treatment
Surgery or procedure
How many people
980 participants
Where
1 siteNetherlands
Study dates
23 Jan 2017to 1 Jun 2018
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: THA and TKA patients

Who may be able to join

  • primary total hip or knee arthroplasty

Who cannot join

  • revision surgery

Trial locations and contacts

1 site in 1 country.

Koen Koenraadt, PhD contact

+31765955000

kkoenraadt@amphia.nl

Rutger van Geenen contact

+31765955000

orthopedie@amphia.nl

Netherlands1 site, 1 recruiting
  • Amphia Hospital

    Breda, North Brabant, 4818CK

    RCI van Geenen, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Prolonged wound drainage after total hip or knee arthroplasty is a very undesirable complication, both from medical as patients view. Wound drainage prolongs hospital admission and is associated with an increased risk of infection (1) post-operative wound drainage of more than 48 hours is associated with an increased infection risk of 42 percent a day in hip arthroplasty and 27 percent a day in knee arthroplasty. (2) Patient organizations report that wound drainage is considered as one of the most undesirable complications.

In our hospital, patients undergoing hip or knee arthroplasty are treated according to a "fast track" protocol, in most cases resulting in a hospital admission of only two days. This increases the chance that patient's release from hospital will be delayed due to wound drainage. The fact that our department recently started to perform hip and knee arthroplasty in a daycare setting increases this chance substantially.

Read more

In hemiarthroplasty of the knee, tissue adhesive was used in addition to conventional wound closure techniques with monocryl sutures. Resorbable monocryl sutures were used so that the usual visit to our outpatient department to remove the sutures was no longer necessary. However, we experienced an increase in wound drainage and complications using only monocryl. The addition of a tissue adhesive decreased the post-operative wound complication drastically. This in mind, we started to use tissue adhesive in regular hip and knee arthroplasty as well. With tissue adhesive in addition to conventional staples, we noticed good results. These results however, were subjective and not officially recorded.

In a previous study, good results are reported in decreasing wound drainage with the use of a tissue adhesive in addition to staples. Clinical relevance was not reported and the study design lacked a cost-effectiveness analysis (3) The increase in cost for the use of the tissue adhesive involved was noted by our board of directors. Because lack of a clear medical of financial benefit, we were asked to minimize the use of tissue adhesive, resulting in usage of tissue adhesive solely in a day care setting, which comprises only 5 to 10 percent of our treated population. Previous study reported a decrease in post-operative wound drainage when tissue adhesive was used in addition to staples in knee arthroplasty. However, no financial benefit is known, therefore this treatment has not been accepted into daily practice. In our department, prolonged hospital admission due to wound drainage is not found to be uncommon. Our hypothesis is that the addition of tissue adhesive in wound closure after hip and knee arthroplasty will significantly decrease post-operative wound drainage, leading to a reduced number of admission days. In addition, we expect less patients to return to our outpatient clinic for non-regular visits due to wound complications. Expensive bandages are used in our standard treatment protocol. Less wound drainage would mean less bandages. All these things combined will lead to a reduction in overall health care costs

Being tested
Tissue adhesive in primary Total Hip and Total Knee arthroplasty
Keywords
Tissue Adhesive
Medical subject headings
Osteoarthritis, Hip, Osteoarthritis, Knee

What participants receive

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

  • Tissue adhesive in primary Total Hip and Total Knee arthroplastyProcedure or surgery

    Use of tissue adhesive in primary Total Hip and Total Knee arthroplasty

What is being measured

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

  1. Admission days

    Measured: 30 days

Timeline

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

  1. First posted12 Jun 2017
  2. Study start23 Jan 2017
  3. Primary completion23 Jan 2018 (estimated)
  4. Study completion1 Jun 2018 (estimated)

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
Retrospective
Enrolment
980 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183583
Sponsor's protocol ID
IIS 15-212
Status last verified
Jun 2017
First submitted
8 Jun 2017
Last updated
12 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by Amphia Hospital at 1 site in Netherlands.

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 1 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: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

Results are not available in the source record.

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

Contact Koen Koenraadt, PhD (+31765955000, kkoenraadt@amphia.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Admission days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Jun 2017; AzTrials last refreshed its copy on 3 Nov 2026.

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