Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

NCT05169229 | Recruiting Phase 2 DMC

• 2 other identifiers: ABOGRAFT-012024-510921-25-00
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Hip; Osteoarthritis, Hip; Antibiotic Resistant Infection; Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Reoperation due to infection or diagnosed PJI 2 years after index surgery.

  2 years after finalizing data collection.

Secondary Outcomes (4)

• 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.

• 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 implant revision due to any reason within 2 and 5 years

  2 and 5 years after finalizing data collection.

• Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection

  2 and 5 years after finalizing data collection.

Other Outcomes (2)

• Differences between the two experimental groups regarding the frequencies of adverse events

  2 and 5 years after finalizing data collection.

• Differences between the two experimental groups regarding the rates of revision due to aseptic loosening

  2 and 5 years after finalizing data collection.

Study Arms (2)

Treatment arm

EXPERIMENTAL

Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.

Drug: Vancomycin + Tobramycin

Placebo

PLACEBO COMPARATOR

Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.

Drug: Saline

Interventions

Vancomycin + Tobramycin DRUG

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.

Also known as: Treatment

Treatment arm

Saline DRUG

As a placebo added to the allograft.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Hip arthroplasty requiring bone graft
• Willing to provide informed consent.
• For women of childbearing potential; a negative pregnancy test prior to surgery.

You may not qualify if:

• Ongoing prosthetic joint infection
• Known allergies and contraindications for the use of vancomycin or tobramycin
• Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
• Expected difficulties to complete 2-year follow-up
• Females of child bearing potential not using contraception
• Pregnant females
• Nursing females

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Region Östergötland: collaborator
• The Swedish Research Council: collaborator

Study Sites (1)

Universitetssjukhuset Linköping

Linköping, Region Östergotland, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Vancomycin; Tobramycin; Therapeutics; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jörg Schilcher, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Wezenberg, PhD

CONTACT

0046101030000; daphne.wezenberg@liu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A phase II, randomized, double-blind, placebo-controlled, multicenter drug trial.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning immediately following publication of the main results article and ending 25 years thereafter, consistent with the retention period for clinical trial data.
• Access Criteria: Access will be granted to qualified researchers for prespecified scientific purposes. Sharing is conditional on: (i) approval of the proposed analysis by the study sponsor and, where legally required, approval of the secondary use by the Swedish Ethical Review Authority (Etikprövningsmyndigheten); (ii) a signed data sharing and data processing agreement outlining the terms of use; and (iii) compliance with the GDPR and applicable Swedish law, including data protection, ethical review, and secrecy provisions. The agreement prohibits any attempt at re-identification and any further sharing of the data. Transfer of personal data outside the EU/EEA will occur only where permitted under GDPR. Requests for access can be submitted to the study sponsor."

Locations

SE (1)