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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-24-05-047447 | Other Identifier | EUDAMED |
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The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic infection.
The clinical investigation will include patients indicated for revision hip arthroplasty due to chronic periprosthetic infection. Subjects will either receive standard CE-marked revision hip implants or the newly developed IP (Infection prevention)- coated revision hip implants. The primary clinical benefit of the IP hip implant components remains the functional restoration of the hip joint and pain relief, as successfully shown for the uncoated predecessor devices, but additionally the IP coating is regarded ancillary to the intended purpose of the implant. Periprosthetic infections are one of the major complications in revision hip arthroplasty, leading to implant re-revision. A clinical investigation to evaluate additional measures to reduce this complication rate in revision total hip arthroplasty therefore has high clinical relevance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IP coated hip arthroplasty implants | Experimental | Participants receive an infection prevention (IP) coated hip implant |
|
| Standard hip arthroplasty implants | Active Comparator | Participants receive a standard (uncoated) hip implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IP PlasmafitÂź Revision cup (and stem) system | Device | Revision total hip arthroplasty (THA) due to periprosthetic joint infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of periprosthetic joint infections | Participants are monitored for 12 months after revision surgery. Every case of periprosthetic joint infection according to the definition of the EBJIS classification counts. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of functional outcome over follow-up period (Harris Hip Score (HHS)) | Harris-Hip-Score: The Harris Hip Score (HHS) is a clinical tool used to evaluate the function of the hip joint, particularly after hip surgery or in cases of hip disease. The HHS consists of 10 items divided into four categories: Pain (maximum 44 points) Function (maximum 47 points) Range of Motion (maximum 5 points) Deformity (maximum 4 points) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lutz Dreyer, Dr. | Contact | +49 7461 95 | 0 | hiprevision_study@bbraun.com |
| Britta Wachter, Dr. | Contact | +49 746195 | 0 | hiprevision_study@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Meller, Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - UniversitÀtsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41699680 | Derived | Alt V, Walter N, Baixauli F, Bialecki J, Dreyer L, Goronzy J, Hardt S, Herold D, Kendoff D, Maenz S, Rak D, Rudert M, Sionek A, Stiehler M, Meller S. HIPrevision - a multicenter prospective randomized control superiority trial of antimicrobial IP-coated revision hip prostheses versus non-IP-coated comparators for the revision of periprosthetic hip joint infections. Trials. 2026 Feb 17;27(1):174. doi: 10.1186/s13063-026-09541-6. |
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| ID | Term |
|---|---|
| D017348 | Microscopy, Electron, Scanning Transmission |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D046529 | Microscopy, Electron, Transmission |
| D008854 | Microscopy, Electron |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
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| 2 years post operative |
| Changes in quality of life | Measure Description: EQ-5D-5L The EQ-5D-5L is a standardized instrument used to measure health outcomes. Developed by the EuroQol Group (EQ), it assesses five dimensions (5D) of health: Mobility Self-care Usual activities Pain/discomfort Anxiety/depression Each dimension has five levels (5L) of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems | 2 years post operative |
| Implant survival | Measure Description: Kaplan-Meier implant survival Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the hip prosthesis. Information on survival of the implant will be collected until the last follow-up of the study patients took place. | 2 years post operative |
| Radiographic assessment | radiographic measurements to assess implant migration, signs of loosening and changes in the fixation area over time | 2 years post operative |
| Occurrence of safety issues with the new device | Adverse events, device failures and component revision will be monitored throughout the study to assess the safety | 2 years post operative |
| Level of silver ion concentration | Laboratory analysis will be performed to monitor silver ion concentration in biospecimen. | 12 months |
| Changes in blood biomarkers for liver function | Participants will be monitored for their level of liver enzymes (ALT, AST, GGT) | 12 months |
| Changes in blood biomarker for kidney function | Participants will be monitored for their level of kidney marker (eGFR). | 12 months |
| Changes in blood biomarker for inflammation | Participants will be monitored for their level of inflammation marker CRP. | 12 months |
| Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP | Recruiting | Otwock | 05-400 | Poland |
|
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |