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

Conditions

• Periprosthetic Joint Infection

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

Interventions

• REMEDY Spectrum IM Spacer Nail — COMBINATION_PRODUCT
  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 and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools.

Study Details

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.

Key Dates

Start date

Feb 1, 2026

Status verified

May 2026

Primary completion

Aug 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Subjects with REMEDY Spectrum IM Spacer Nail
  This is the REMEDY Spectrum IM Spacer Nail treatment group.

Primary Outcome Measure

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

Central Contacts

• Crystal Djaba
  470-736-7850
  [email protected]
• Jacob Schafer
  [email protected]

Locations (3)

Find similar trials in Lansing, MI

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