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

NCT03183583 | Unknown

• 1 other identifier: IIS 15-212
• Study Type: observational
• Target: 980
• Locations: 1 country
• Sites: 1

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

Keywords

Tissue Adhesive

Outcome Measures

Primary Outcomes (1)

• Admission days

  30 days

Interventions

Tissue adhesive in primary Total Hip and Total Knee arthroplasty PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

THA and TKA patients

You may qualify if:

• primary total hip or knee arthroplasty

You may not qualify if:

• revision surgery

Sponsors & Collaborators

• Amphia Hospital: lead
• R.C.I. van Geenen, orthopedic surgeon, Amphia, Breda, The Netherlands: collaborator
• Ethicon, Inc.: collaborator

Study Sites (1)

Amphia Hospital

Breda, North Brabant, 4818CK, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Interventions

Tissue Adhesives; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Rutger van Geenen, MD, PhD

  Amphia Hospital, Breda, the Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Koenraadt, PhD

CONTACT

+31765955000; kkoenraadt@amphia.nl

Rutger van Geenen

CONTACT

+31765955000; orthopedie@amphia.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: coordinator FORCE

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: January 23, 2017
• Primary Completion: January 23, 2018
• Study Completion: June 1, 2018
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)