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.

NCT07225751 | Recruiting FDA Device

• 1 other identifier: FA-2025-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

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

Keywords

ankle arthrodesis; hindfoot fusion

Outcome Measures

Primary Outcomes (1)

• Radiographic fusion by CT scan

  The primary endpoint is the incidence of fusion at each side by CT analysis as assessed by the independent radiological expert at 24 weeks post-op

  Week 24 post-op

Secondary Outcomes (5)

• Radiographic fusion by CT scan

  Week 52

• Radiographic Fusion by plain radiographs

  week 12, week 24, week 52 post-surgery

• Functional

  Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery.

• Functional

  Screening, Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery.

• Functional

  Screening, Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery.

Study Arms (2)

MagnetOs

EXPERIMENTAL

Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: MagnetOs Putty or MagnetOs Easypack Putty

Device: MagnetOs

Autograft

ACTIVE COMPARATOR

Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: Autograft

Other: Autograft

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.

MagnetOs

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.

Autograft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
• Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old
• Patients requiring one of the following hindfoot fusion procedures, using surgical technique, necessitating rigid hardware fixation and supplemental bone graft/ substitute: ankle fusion (tibiotalar) subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, OR double fusion (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints).
• Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.

You may not qualify if:

• Expected to need secondary intervention within one year following surgery.
• Had prior fusion or attempted fusion of the joints to be fused.
• Patient is not ambulatory.
• Surgical technique where bone graft is not expected to be used.
• Conditions at the surgeon's discretion in which general bone grafting is not advisable.
• Radiographic evidence of fractures or pathologies around the fusion that could negatively impact the fusion process (e.g., growth plate fracture around the fusion or bone cysts).
• Significant vascular impairment proximal to the graft site.
• Acute and/or chronic infections in the operated area (soft tissue infections; bacterial bone diseases; osteomyelitis)
• Pre-existing sensory impairment (e.g. diabetes, Charcot). Diabetics patients with HbA1c greater than 7.0 OR that were not sensitive to the 5.07 monofilament will be excluded.
• Metabolic disorders know to adversely affect the skeleton (e.g., renal osteodystrophy or hypercalcemia).
• If intraoperative soft tissue coverage is not planned or possible.
• Receiving treatment with medication interfering with calcium metabolism (chronic use of glucocorticoid and use high dose NSAIDs 800 mg TID for \> the first 6 weeks post-op).
• Has benign or malignant tumor at the surgical site.
• Has history or presence of active malignancy (non-invasive skin cancer is allowed).
• Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements (e.g. prisoners, physically or mentally compromised, etc.).

Sponsors & Collaborators

• Kuros Biosurgery AG: lead

Study Sites (5)

Steadman Philippon Research Institute

Vail, Colorado, 81657, United States

RECRUITING

Hughston Foundation Inc

Columbus, Georgia, 31909, United States

RECRUITING

OrthoCarolina Research Institute, Inc

Charlotte, North Carolina, 28207, United States

RECRUITING

Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Erlanger Orthopaedics

Chattanooga, Tennessee, 37403, United States

RECRUITING

MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Central Study Contacts

Cesar Silva, MD

CONTACT

9702156793; cesar.silva@kurosbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 10, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2025-12

Locations

US (5)