REMEDY SPECTRUM intramedullary spacer nail for ankle infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm Phase 2 study in which all enrolled adults with ankle-related infections will receive the REMEDY SPECTRUM intramedullary (IM) spacer nail. Subjects will be enrolled over approximately 12 months with a 6-month post-operative follow-up, for an expected total duration of about 18 months. The study will collect surgical, clinical, and infection-related outcomes to determine device safety and effectiveness for local stabilization and antibiotic delivery in the ankle. Key eligibility requires adults ≥21 years with ankle infection, sufficient soft-tissue coverage and vascular status, and the ability to consent and comply with follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be ≥ 21 years of age
2. Have an ankle-related infection
3. Is skeletally mature, as evidenced by closed epiphyses.
4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
6. 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:

1. Infections that do not involve the ankle
2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
3. Affected limb is dysvascular
4. Where adequate soft-tissue coverage cannot be achieved
5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
7. Are currently a prisoner
8. 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.
9. History of vancomycin or gentamicin allergy
10. Are implanted with other antibiotic eluting products.

Where it's running

• University of Michigan Health - Sparrow Clinical Research Institute
  Lansing, Michigan, United States Recruiting
• OrthoCarolina Research Institute
  Charlotte, North Carolina, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Crystal Djaba
• Email: cdjaba@mcra.com
• Phone: 470-736-7850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adding rifampin to antibiotics after DAIR for staphylococcal periprosthetic joint infection

  This trial tests whether giving rifampicin in addition to standard antibiotics for adults with staphylococcal periprosthetic joint infection after DAIR improves long-term infection control.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT07313215

• Optimizing skin cleansing before shoulder surgery

  This study is testing whether using different pressure techniques to apply a skin cleanser can help reduce bacteria on the skin before shoulder surgery.

  Recruiting University of Washington · Seattle, Washington · NCT06464770

• Comparing biopsy and aspiration for diagnosing joint infections in shoulder and elbow surgeries

  This study is testing whether using a needle to take fluid from the joint or doing a surgical biopsy is better for diagnosing infections in patients having shoulder or elbow surgeries.

  Recruiting Wrightington, Wigan and Leigh NHS Foundation Trust · Wigan, Lancashire · NCT06268795

• Reducing infections after total joint replacement surgery

  This study is testing if using special antiseptic solutions and antibiotics can help prevent infections in adults having total joint replacement surgery.

  Recruiting Phase 3 Hamilton Health Sciences Corporation · Hamilton, Ontario · NCT06126614

• Evaluating antibiotic treatment after joint revision surgery for infection

  This study is testing if a specific antibiotic treatment after joint revision surgery for infection can help patients recover better and prevent further infections.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT05284318

• Periprosthetic Joint Infection After Hip or Knee Replacement: Causes and Prevention

  This study tests whether certain factors before and after hip or knee replacement help predict and prevent peri-implant infections in adults 45 and older.

  Recruiting People's Friendship University of Russia · Moscow · NCT07813832

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.