NCT05169229 Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
| NCT ID | NCT05169229 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University Hospital, Linkoeping |
| Condition | Arthroplasty, Replacement, Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,100 participants in total. It began in 2022-04-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 reoperation. 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
Contact & Investigator
Jörg Schilcher, PhD
PRINCIPAL INVESTIGATOR
Linkoeping University
Frequently Asked Questions
Who can join the NCT05169229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthroplasty, Replacement, Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05169229 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05169229 currently recruiting?
Yes, NCT05169229 is actively recruiting participants. Contact the research team at daphne.wezenberg@liu.se for enrollment information.
Where is the NCT05169229 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT05169229 clinical trial?
NCT05169229 is sponsored by University Hospital, Linkoeping. The principal investigator is Jörg Schilcher, PhD at Linkoeping University. The trial plans to enroll 1,100 participants.