|- candidate number||24584|
|- NTR Number||NTR5960|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jul-2016|
|- Secondary IDs||843004101 ZonMW|
|- Public Title||LEAK study|
|- Scientific Title||LEAK-study LEakage After primary Knee and hip arthroplasty; finding the best way to treat wound leakage after primary arthroplasty A prospective nationwide multicenter randomised controlled trial|
|- hypothesis||Surgical treatment (DAIR on day 10) will result in a 50% reduction rate of revision for PJI up to one year after primary TKA/THA compared to nonsurgical treatment. Consequently surgical treatment is more (cost) effective compared to nonsurgical treatment. DAIR on day 10 will result in improvement of disease-specific and general health-related quality of life compared to nonsurgical treatment.|
|- Healt Condition(s) or Problem(s) studied||Arthropathy , Knee, Hip, Wound healing|
|- Inclusion criteria||Patients aged 18 or older who have undergone a TKA/THA and experience persistent wound leakage at day 9.|
|- Exclusion criteria||- Mental or physical disability to fulfill study requirements.|
- Insufficient command of the Dutch language.
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2017|
|- planned closingdate||1-feb-2020|
|- Target number of participants||388|
|- Interventions||non-surgical and surgical treatment of persistent wound leakage|
|- Primary outcome||What is the effectiveness of early intervention (DAIR day 10) versus usual care (nonsurgical treatment) in patients with
persistent wound leakage? Primary endpoint will be revision surgery for PJI up to one year.|
|- Secondary outcome||What is the cost effectiveness and cost utility of early intervention (DAIR day 10) versus usual care (nonsurgical treatment) in
patients with persistent wound leakage? Primary endpoint will be revision surgery for PJI up to one year.
What is the impact of early intervention (DAIR day 10) compared to usual care (nonsurgical treatment) on disease-specific and
general health-related quality of life at one year?|
|- Timepoints||T0= at time of inclusion|
T1= at 1 year followup
|- Trial web site||n/a|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. MD PhD P.C. Jutte|
|- CONTACT for SCIENTIFIC QUERIES||Dr. MD PhD P.C. Jutte|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||RATIONALE:|
Persistent wound leakage after primary Total Knee or Hip Arthroplasty (TKA/THA) is associated with Prosthetic Joint Infection
(PJI). More than 50,000 TKA/THA are performed yearly in the Netherlands. PJI is a serious complication with major implications
for a patient’s quality of life and costs are high (± € 30,000). Clinical practice for the treatment of persistent wound leakage
varies considerably, with both nonsurgical or surgical treatment options. The dilemma is that not all postoperative prolonged
wound leakages are a proxy for PJI. So far literature shows no evidence for the superiority of either treatment.
To determine clinical and cost effectiveness and impact on quality of life of early intervention (DAIR on day 10) versus usual
care (nonsurgical treatment) in patients with persistent wound leakage.
Early intervention reduces 50% revision surgery for PJI =1 year compared to usual care.
A randomized controlled trial comparing two clinical pathways.
Patients aged 18 or older who have undergone a TKA/THA and experience persistent wound leakage at day 9.
Surgical treatment: DAIR on day 10, cleaning of wound and prosthesis, cultures and AB.
Nonsurgical treatment: bed rest, stop exercise, pressure bandage.
Primary outcome: reduction in revision surgeries for PJI =1 year after TKA/THA. Secondary outcomes: number of DAIRs, costs,
and disease-specific and general health-related quality of life.
SAMPLE SIZE CALCULATION/DATA ANALYSIS:
The expected reduction rate of revision surgery for PJI as a result of early intervention is estimated at 50%. The numbers needed from inclusion are 194 in each arm, compensating with 20% for lost to follow-up (alpha 0.05, power 80% one-sided).
COST-EFFECTIVENESS ANALYSIS/BUDGET IMPACT ANALYSIS:
Cost-effectiveness analysis (costs per prevented revision surgery for PJI), cost-utility analysis from a societal perspective (costs
per QALY) and a probabilistic Budget Impact Analysis will be conducted.
The LEAK study is prepared between 1-9 and 31-12-16; patients inclusion will be from 1-1-17 to 1-1-18 with a maximum
extension of six months. Data analysis will finish within 6 months of completion of the last follow-up patient. Total study length is
|- Main changes (audit trail)|
|- RECORD||8-jul-2016 - 12-feb-2017|