A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.

Conditions

• Ankle Arthrodesis or Arthroplasty
• Ankle Deformity
• Ankle Disease
• Hindfoot Arthrodesis
• Hindfoot Fusion
• Hindfoot Pathologies

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MagnetOs — DEVICE
  MagnetOs will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.
• Autograft — OTHER
  In this study, the comparator is autograft and will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.

Study Details

This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders. In this study, MagnetOs Putty and MagnetOs Easypack Putty will be use according to the latest Instructions For Use, standalone in the foot and ankle.

Key Dates

Start date

Nov 25, 2025

Status verified

Dec 2025

Primary completion

Oct 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

126 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MagnetOs
  Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: MagnetOs Putty or MagnetOs Easypack Putty
• Active Comparator: Autograft
  Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: Autograft

Primary Outcome Measure

Radiographic fusion by CT scan [ Time Frame: Week 24 post-op ]

Central Contacts

• Cesar Silva, MD
  9702156793
  [email protected]

Locations (5)

Find similar trials in Vail, CO