Refobacin Revision-3 Bone Cement Post-Market Study

Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation

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

Study Overview

• Status: Withdrawn
• Conditions: Revision Arthroplasty
• Intervention / Treatment: Device: Revision arthroplasty

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3582
    • Diakonessenhuis UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population target is all subjects undergoing knee or hip revision surgeries with Refobacin® Revision-3 and a Zimmer Biomet implant approved for revision cases and who meet all of the inclusion and none of the exclusion criteria. Patients requiring a Zimmer Biomet StageOne™ spacer during a two-stage revision will be enrolled for subgroup analysis too.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	removal of any metal components of the hip or knee implants used in combination with the cement; frequency and incidence of adverse events	3, 5 and 10 years post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQuol 5D (EQ-5D) Score	Subject quality of life assessed through the completion of an EQ-5D questionnaire, when available	1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Radiographic evaluation	Radiographic evaluation, when available, include but is not limited to: radiolucency, cement mantle, osteolysis, atrophy, hypertrophy, migration/subsidence and heterotopic ossification.	1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Harris Hip Score / Knee Society Score	Pain and functional performance assessed through the completion of an Harris Hips Score (HHS) or Knee Society Score (KSS) questionnaires, when available, depending on whether the revision procedure was performed on hip or knee	1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Emilie Rohmer, Clin Op Dir, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: bone cement; revision surgery; Refobacin Revision
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Reoperation; Second-Look Surgery
• Other Study ID Numbers: CME2021-28C