Eakage After primary Knee and hip arthroplasty; a randomized controlled study for finding the best way to treat wound leakage after primary arthroplasty

Recruiting

• Conditions: Postoperative woundleakage/ woundleakage; 10023213

• Registration Number: NL-OMON43183
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 388

Inclusion Criteria

Patients aged 18 years or older with persistent wound leakage at day 9 after TKA/THA.

Exclusion Criteria

- Mental disability to fulfill study requirements (e.g dementia).
- Insufficient command of the Dutch language.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: reduction in revision surgeries for PJI <1 year after TKA/THA.<br /><br>Secondary outcomes: number of DAIRs, costs,<br /><br>and disease-specific and general health-related quality of life.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cost-effectiveness analysis (costs per prevented revision surgery for PJI),<br /><br>cost-utility analysis from a societal perspective (costs<br /><br>per QALY) and a probabilistic Budget Impact Analysis will be conducted.</p><br>