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

NCT ID: NCT03183583

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 980 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-23
• Study Completion Date: 2018-06-01

Brief 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 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

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Tissue adhesive in primary Total Hip and Total Knee arthroplasty

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• primary total hip or knee arthroplasty

Exclusion Criteria

• revision surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

R.C.I. van Geenen, orthopedic surgeon, Amphia, Breda, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Ethicon, Inc.

INDUSTRY

Sponsor Role: collaborator

Amphia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Koen Koenraadt

coordinator FORCE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rutger van Geenen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amphia Hospital, Breda, the Netherlands

Locations

Amphia Hospital

Breda, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Koen Koenraadt, PhD

Role: CONTACT

kkoenraadt@amphia.nl

+31765955000

Rutger van Geenen

Role: CONTACT

orthopedie@amphia.nl

+31765955000

Facility Contacts

RCI van Geenen, MD, PhD

Role: primary

Other Identifiers

IIS 15-212

Identifier Type: -

Identifier Source: org_study_id