Refobacin Revision-3 Bone Cement Post-Market Study

Zimmer Biomet

Status: Begins enrollment this month

Conditions: Revision Arthroplasty

Treatments: Device: Revision arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT06699160

CME2021-28C

Details and patient eligibility

About

The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on:

• removal of any metal components of the hip or knee implants used in combination with the cement
• frequency and incidence of adverse events
• overall pain and functional performance, subject quality of life, and radiographic parameters

Full description

Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures.

Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is 18 years or older and skeletally mature.

• Patient is capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program.

• Patient gave consent to take part in the study by signing the Ethics Committee approved Informed Consent Form (ICF).

• Patient who underwent or will undergo a hip or knee revision surgery with a Zimmer Biomet implant and the Refobacin® Revision-3 Bone Cement.

• Patient meets at least one of the following indications, as stated in the Instructions for Use (IFU):

  • Patients requires a revision operation resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.
  • Patients undergoing a two-stage revision that requires the fabrication and fixation of short-term total or hemi joint StageOne™ spacers. The device is intended for use in conjunction with systemic antimicrobial therapy (standard approach to an infection).

Additional inclusion criteria for patients receiving a StageOne™ spacer, as stated in the IFU:

• Implantation period of a maximum of 180 days.
• The molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Exclusion criteria

• Patient is unwilling or unable to give consent or to comply with the follow-up program.

• Patient is known to be pregnant or breastfeeding.

• Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study.

• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).

• Patient has plans to relocate during the study follow-up period.

• As stated in the IFU, patient with known hypersensitivity to gentamicin and/or clindamycin and/or to other constituents of the bone cement.

• Additional exclusion criteria for patients receiving a StageOne™ spacer, as stated in the IFU:

  • The infected Total Hip/Knee Replacement (THR/TKR) devices cannot be removed.
  • A systemic or secondary remote infection is expected or confirmed.
  • Lack of adequate bone structure precludes adequate support of the prosthesis in the proximal femur or acetabular region, or
  • Lack of adequate competence (anatomical and functional) of peripheral ligamentous apparatus and extensor mechanism.
  • The patient is sensitive (allergic) to aminoglycosides.