Recruiting PHASE2 Arthroplasty, Replacement, Hip

New treatment option for Arthroplasty, Replacement, Hip

Official title Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

ClinicalTrials.gov ID: NCT05169229

What this study is testing

What is Vancomycin + Tobramycin?

Vancomycin + Tobramycin is an investigational medicine, being studied as a potential treatment for arthroplasty, replacement, hip.

Also referred to as Treatment.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join 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 likely can't join 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...
  • Expected difficulties to complete 2-year follow-up
  • Females of child bearing potential not using contraception
  • Pregnant females
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Linköping, Region Östergotland, Sweden

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Linköping, Region Östergotland, Sweden. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.