Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
268 participants
INTERVENTIONAL
2025-06-25
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IP coated hip arthroplasty implants
Participants receive an infection prevention (IP) coated hip implant
IP Plasmafit® Revision cup (and stem) system
Revision total hip arthroplasty (THA) due to periprosthetic joint infection
Standard hip arthroplasty implants
Participants receive a standard (uncoated) hip implant
IP Plasmafit® Revision cup (and stem) system
Revision total hip arthroplasty (THA) due to periprosthetic joint infection
Interventions
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IP Plasmafit® Revision cup (and stem) system
Revision total hip arthroplasty (THA) due to periprosthetic joint infection
Eligibility Criteria
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Inclusion Criteria
* Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical standard at the clinical investigation site
* According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits
* ASA physical status I - III
* Patient's signed written informed consent is available
Exclusion Criteria
* The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
* Patients who require plate osteosynthesis at the implantation site
* Patients with an already implanted silver-coated device
* Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
* Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
* Severe soft tissue defects that require local or free flap procedure
* Periprosthetic joint infections with evidence of fungal infection
* Antibiotic suppression therapy
* BMI \> 40 kg/m2
* Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions
* Known or patient reported hypersensitivity to silver or titanium
* Patients held in a custodial setting
* Patients in a relationship of dependence on the sponsor, the clinic or the investigator
* Patients with contraindication for the investigational and comparator devices:
* in case of secondary diseases influencing the function of the joint implant
* in case of severe osteoporosis or osteomalacia
* in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage
* in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated
18 Years
ALL
No
Sponsors
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Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Sebastian Meller, Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - Universitätsmedizin Berlin
Berlin, , Germany
Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
Otwock, , Poland
Countries
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Central Contacts
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Facility Contacts
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Sebastian Meller, Dr.
Role: primary
Jerzy Białecki, Prof. Dr.
Role: primary
Other Identifiers
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CIV-24-05-047447
Identifier Type: OTHER
Identifier Source: secondary_id
AAG-G-H-2023
Identifier Type: -
Identifier Source: org_study_id
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