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Clinical Trials/EUCTR2021-001708-14-SE
EUCTR2021-001708-14-SE
Active, not recruiting
Phase 1

Antibiotic Impregnated Bone Graft to reduce infection in revision hip replacement. The ABOGRAFT trial - ABOGRAFT

Region Östergötland0 sites1,200 target enrollmentMay 12, 2021
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ConditionsPatients scheduled for any type of reoperation of a pre-existing hip arthroplasty requiring bone graftingTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients scheduled for any type of reoperation of a pre-existing hip arthroplasty requiring bone grafting
Sponsor
Region Östergötland
Enrollment
1200
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 12, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\* Age \= 18 years
  • •\* Hip arthroplasty requiring reoperation or revision with bone graft
  • •\* Willing to provide informed consent.
  • •\* For women of childbearing potential; a negative pregnancy test prior to reoperation.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 240
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 960

Exclusion Criteria

  • •\* Patients with prosthetic joint infection as the reason for the reoperation
  • •\* 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
  • •\* Women of child bearing potential not using contraception
  • •\* Pregnant women
  • •\* Nursing women

Outcomes

Primary Outcomes

Not specified

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