Refobacin Revision-3 Bone Cement Post-Market Study

NCT06699160 | Withdrawn

• 1 other identifier: CME2021-28C
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Revision Arthroplasty

Keywords

revision surgery; bone cement; Refobacin Revision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• EuroQuol 5D (EQ-5D) Score

  1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)

• Harris Hip Score / Knee Society Score

  1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)

• Radiographic evaluation

  1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)

Interventions

Revision arthroplasty DEVICE

Hip or knee revision surgery resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.

Also known as: Revision, Revision surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Diakonessenhuis UMC Utrecht

Utrecht, 3582, Netherlands

Location

MeSH Terms

Interventions

Second-Look Surgery; Reoperation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Emilie Rohmer, Clin Op Dir

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

NL (1)