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Recruiting NCT06428448

Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections

Phase II Interventional Periprosthetic Joint Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REMEDY Spectrum IM Spacer Nail.
Who it may be relevant to
Registry conditions: Periprosthetic Joint Infection. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections

Overview

This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.

Interventions

  • Combination product REMEDY Spectrum IM Spacer Nail
    The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin. The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm an

Primary outcome measures

  • Successful Treatment of Infection Based on Lab Values and Culture [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Be ≥ 21 years of age
  • Have an ankle-related infection
  • Is skeletally mature, as evidenced by closed epiphyses.
  • Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
  • Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
  • If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.

Exclusion criteria

  • Infections that do not involve the ankle
  • Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
  • Affected limb is dysvascular
  • Where adequate soft-tissue coverage cannot be achieved
  • Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
  • Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
  • Are currently a prisoner
  • Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
  • History of vancomycin or gentamicin allergy
  • Are implanted with other antibiotic eluting products.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Michigan Health - Sparrow Clinical Research Institute — Lansing
  • OrthoCarolina Research Institute — Charlotte
  • Duke University Medical Center — Durham

Identifiers

NCT: NCT06428448 · OR-SN-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗