Clinical trial NCT06699160: Refobacin Revision-3 Bone Cement Post-Market Study
Official title: Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Revision Arthroplasty
Keywords: revision surgery
bone cement
Refobacin Revision
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survivorship
timeFrame: 3, 5 and 10 years post-operatively
Secondary outcomes:
measure: EuroQuol 5D (EQ-5D) Score
timeFrame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
measure: Harris Hip Score / Knee Society Score
timeFrame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
measure: Radiographic evaluation
timeFrame: 1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective)
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis UMC Utrecht
Study officials:
affiliation: Zimmer Biomet
name: Emilie Rohmer, Clin Op Dir
role: STUDY_DIRECTOR
References: