Antibiotic Resistant Infection, Arthroplasty, Replacement, Hip, Osteoarthritis, Hip, Prosthetic Joint Infection
Conditions
Brief summary
Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities. The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent. Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.
Interventions
DRUGVancomycin + Tobramycin
1 g vancomycin (powder) diluted in 8 ml tobramycin (40 -80mg/ml). Added to the prepared allograft before the allograft is used during the revision surgery.
DRUGSaline
As a placebo added to the allograft.
Sponsors
University Hospital, Linkoeping
Region Östergötland
The Swedish Research Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded
Intervention model description
A phase II, randomized, double-blind, placebo-controlled, multicenter drug trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Hip arthroplasty requiring bone graft 3. Willing to provide informed consent. 4. For women of childbearing potential; a negative pregnancy test prior to surgery.
Exclusion criteria
1. Ongoing prosthetic joint infection 2. Known allergies and contraindications for the use of vancomycin or tobramycin 3. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation 4. Expected difficulties to complete 2-year follow-up 5. Females of child bearing potential not using contraception 6. Pregnant females 7. Nursing females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty. | 2 years after finalizing data collection. | Reoperation due to infection or diagnosed PJI 2 years after index surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reoperation due to infection or diagnosis of PJI with any microorganism in the same hip joint within 2 years after THA. | All infections within 2 years after index surgery. | Whereas the major outcome only takes into account infections that are sensitive to the antibiotic used this secondary outcomes includes all infections |
| Time to and cause for reoperation for any reason within 2 and 5 years | 2 and 5 years after finalizing data collection. | Time to and cause for reoperation for any reason within 2 and 5 years |
| Time to and cause for implant revision due to any reason within 2 and 5 years | 2 and 5 years after finalizing data collection. | Time to and cause for implant revision due to any reason within 2 and 5 years |
| Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection | 2 and 5 years after finalizing data collection. | Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection. |
Countries
Sweden
Contacts
CONTACTDaphne Wezenberg, PhD
PRINCIPAL_INVESTIGATORJörg Schilcher, PhD
Linkoeping University
Outcome results
None listed