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.
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.
Netherlands1 site, 1 recruiting
- Recruiting
Amphia Hospital
Breda, North Brabant, 4818CK
RCI van Geenen, MD, PhD
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
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- 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.
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.
- First posted12 Jun 2017
- Study start23 Jan 2017
- Primary completion23 Jan 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- R.C.I. van Geenen, orthopedic surgeon, Amphia, Breda, The Netherlands, Ethicon, Inc.
- Responsible party
- Principal investigator, Koen Koenraadt, Amphia Hospital
- Investigators
- Rutger van Geenen, MD, PhD, Principal investigator, Amphia Hospital, Breda, the Netherlands
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Adhesive in Hip and Knee Arthroplasty, A Cost -Effectiveness Analysis
- ClinicalTrials.gov ID
- NCT03183583
- Acronym / sponsor ID
- IIS 15-212
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- Tissue Adhesive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Collaborators
- R.C.I. van Geenen, orthopedic surgeon, Amphia, Breda, The Netherlands, Ethicon, Inc.
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 23 Jan 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- THA and TKA patients
Key inclusion criteria (1 listed)
- primary total hip or knee arthroplasty
Key exclusion criteria (1 listed)
- revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue adhesive in primary Total Hip and Total Knee arthroplastyUse of tissue adhesive in primary Total Hip and Total Knee arthroplasty | Procedure or surgery | – |
Primary outcome
Admission days
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rutger van Geenen, MD, PhD principal investigator
Amphia Hospital, Breda, the Netherlands
1 site in 1 country: see every site and its status.
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.