IP-coated Revision Hip Implants

Not Applicable

Not yet recruiting

• Conditions: Peri-Prosthetic Joint Infection

• Registration Number: NCT06737809
• Lead Sponsor: Aesculap AG

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Study Start: 2025-05
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 268

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

• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

• The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect

• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of periprosthetic joint infections	12 months	Participants are monitored for 12 months after revision surgery. Every case of periprosthetic joint infection according to the definition of the EBJIS classification counts.

Secondary Outcome Measures

Name	Time	Method
Implant survival	2 years post operative	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.
Radiographic assessment	2 years post operative	radiographic measurements to assess implant migration, signs of loosening and changes in the fixation area over time
Occurrence of safety issues with the new device	2 years post operative	Adverse events, device failures and component revision will be monitored throughout the study to assess the safety
Change of functional outcome over follow-up period (Harris Hip Score (HHS))	2 years post operative	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)
Changes in quality of life	2 years post operative	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
Level of silver ion concentration	12 months	Laboratory analysis will be performed to monitor silver ion concentration in biospecimen.
Changes in blood biomarkers for liver function	12 months	Participants will be monitored for their level of liver enzymes (ALT, AST, GGT)
Changes in blood biomarker for kidney function	12 months	Participants will be monitored for their level of kidney marker (eGFR).
Changes in blood biomarker for inflammation	12 months	Participants will be monitored for their level of inflammation marker CRP.