LEAK study

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.

OBJECTIVE RESEARCHQUESTION:

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.

HYPOTHESIS:

Early intervention reduces 50% revision surgery for PJI =1 year compared to usual care.

STUDY DESIGN:

A randomized controlled trial comparing two clinical pathways.

STUDY POPULATION/DATASETS:

Patients aged 18 or older who have undergone a TKA/THA and experience persistent wound leakage at day 9.

INTERVENTION:

Surgical treatment: DAIR on day 10, cleaning of wound and prosthesis, cultures and AB.

USUAL CARE/COMPARISON:

Nonsurgical treatment: bed rest, stop exercise, pressure bandage.

OUTCOME MEASURES:

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.

TIME SCHEDULE:

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
3 years.

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.

T0= at time of inclusion

T1= at 1 year followup

non-surgical and surgical treatment of persistent wound leakage