Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Phase 2

Recruiting

• Conditions: Arthroplasty, Replacement, Hip; Osteoarthritis, Hip; Antibiotic Resistant Infection; Prosthetic Joint Infection
• Interventions: Drug: Saline; Drug: Vancomycin + Tobramycin

• Registration Number: NCT05169229
• Lead Sponsor: University Hospital, Linkoeping

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-23
• Study Start: 2022-04-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2030-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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. Women of child bearing potential not using contraception
6. Pregnant women
7. Nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.
Treatment arm	Vancomycin + Tobramycin	Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.

Primary Outcome Measures

Name	Time	Method
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 of revision surgery.

Secondary Outcome Measures

Name	Time	Method
Time and cause for reoperation for any reason within 2 and 5 years	2 and 5 years after finalizing data collection.	Time and cause for reoperation for any reason within 2 and 5 years
Time and cause for implant revision due to any reason within 2 and 5 years	2 and 5 years after finalizing data collection.	Time and cause for implant revision due to any reason within 2 and 5 years
Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection	2 and 5 years after finalizing data collection.	Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection

Trial Locations

Locations (1)

Universitetssjukhuset Linköping; 🇸🇪 Linköping, Region Östergotland, Sweden