Recruiting

MagnetOs Putty

Sponsor:

Kuros Biosurgery AG

Code:

NCT07225751

Conditions

Ankle Arthrodesis or Arthroplasty

Hindfoot Fusion

Ankle Deformity

Ankle Disease

Hindfoot Arthrodesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MagnetOs

Autograft

Study Details

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

Ankle Arthrodesis or Arthroplasty

Hindfoot Fusion

Ankle Deformity

Ankle Disease

Hindfoot Arthrodesis

Study ID

NCT07225751

Start date

Nov 25, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion:

1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
2. Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old
3. 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).
4. Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.

Exclusion:

1. Expected to need secondary intervention within one year following surgery.
2. Had prior fusion or attempted fusion of the joints to be fused.
3. Patient is not ambulatory.
4. Surgical technique where bone graft is not expected to be used.
5. Conditions at the surgeon's discretion in which general bone grafting is not advisable.
6. 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).
7. Significant vascular impairment proximal to the graft site.
8. Acute and/or chronic infections in the operated area (soft tissue infections; bacterial bone diseases; osteomyelitis)
9. 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.
10. Metabolic disorders know to adversely affect the skeleton (e.g., renal osteodystrophy or hypercalcemia).
11. If intraoperative soft tissue coverage is not planned or possible.
12. 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).
13. Has benign or malignant tumor at the surgical site.
14. Has history or presence of active malignancy (non-invasive skin cancer is allowed).
15. 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.).
16. Is involved in active litigation relating to his/her foot and ankle condition.
17. Participation in an investigational study within 30 days prior to surgery for study devices.
18. Patient with body mass index (BMI) > 50.
19. Patient cannot comply with all post-operative evaluation and visits .
20. Any pre-existing condition that the surgeon determines could interfere with the patient's ability to perform objective functional measurements.
21. Women who are or intend to become pregnant within the next 12 months.

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

MagnetOs

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University California Davis

Recruiting

Sacramento, California, United States, 95816

Principal Investigator:

Eric Giza, MD

Steadman Philippon Research Institute

Recruiting

Vail, Colorado, United States, 81657

Contacts

Hughston Foundation Inc

Recruiting

Columbus, Georgia, United States, 31909

Contacts

Collier Watson, MD

b.collier.watson@gmail.com

OrthoCarolina Research Institute, Inc

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Integrity Orthopedics and Sports Medicine

Recruiting

Chattanooga, Tennessee, United States, 37404

Centers for Advanced Orthopaedics

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Steve Neufeld, MD

sneufeld@cfaortho.com

More Information

Sponsor

Kuros Biosurgery AG

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • ankle arthrodesis
  • hindfoot fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kuros Biosurgery AG on 2026-09-01.