Open Pilon With FIBERGRAFT AERIDYAN Matrix Bioactive Glass

NCT07227493 | Recruiting FDA Device

• 2 other identifiers: 21223070081670
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Open pilon fractures are challenging problems to manage. Infection rates vary from 6-30% and metaphyseal nonunion varies from 7-20%. The current recommendation for the management of open pilon fractures with bone loss is a staged approach, with internal fixation around an antibiotic spacer. Fibergraft Aeridyan Bone Graft Matrix is currently used along with other forms of allograft at our institution for filling bone voids in open pilon fractures. This is a prospective, observational study looking at the use of Fibergraft Aeridyan bone graft matrix and its efficacy in open pilon fractures. Everything in this study will be according to the standard of care at our institution other than two research only CT scans. One will be performed at the patient's 6-month visit and the other will be performed at the patient's 12-month visit. The investigators hypothesize that Fibergraft Aeridyan Bone Graft Matrix will lead to improved outcomes when compared to standard bone graft for patients by decreasing infection and nonunion rates.

Conditions

Open Pilon Fractures

Keywords

pilon; bone graft; open pilon; fibergraft; fibergraft aeridyan

Outcome Measures

Primary Outcomes (1)

• The number of participants that demonstrate radiographic healing at 12 months, as assessed by the mRUST

  Participants will be assessed for radiographic healing through a modified radiographic union score for tibial fractures (mRUST), with an average grade of 6-8 per radiograph after application of FIBERGRAFT AERIDYAN Matrix bioactive glass and ORIF at 12 months. mRUST is scored on a scale of 1-4 for each cortex. 1: no callus is present, 2: callus is present, 3: bridging callus is present, 4: fracture line is no longer visible. 2 cortices are visible per radiographic image. Therefore, there is a max score of 8 per radiograph. Scores with an average of 6-8 in this study are deemed as demonstrating radiographic healing.

  12 months

Secondary Outcomes (2)

• The number of participants that experience wound complications, as assessed by a part of standard of care treatment

  12 months

• The number of participants that demonstrate radiographic healing at 6 months, as assessed by the mRUST

  6 months

Study Arms (1)

Fibergraft Aeridyan Bone Graft Matrix

Patients in this group will be those who present to our institution with an open pilon fracture who receive the Fibergraft Aeridyan Bone Graft Matrix as part of their treatment for their pilon fracture.

Device: Fibergraft Aeridyan Matrix

Interventions

Fibergraft Aeridyan Matrix DEVICE

FIBERGRAFT™ Aeridyan™ Matrix is a resorbable porous bone graft substitute made from 45S5 bioactive glass, boron bioactive glass and type I collagen. The implantable material is provided as a premixed Matrix of bioactive granules and microspheres in a collagen carrier.

Fibergraft Aeridyan Bone Graft Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to our institution with an open pilon fracture that will undergo open reduction with internal fixation and will require bone grafting.

You may qualify if:

• years of age or older
• Open pilon fracture requiring bone grafting
• Able to provide informed consent for the study prior to definitive care

You may not qualify if:

• Under 18 years of age
• Open pilon fracture not requiring bone grafting
• Receiving definitive care at an outside facility
• Unlikely to make follow-up appointments
• Active infection at the time of definitive care
• Unable to provide informed consent prior to definitive care
• Prisoners
• Pregnant patients

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• DePuy Orthopaedics: collaborator

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65201, United States

RECRUITING

Related Publications (12)

• Ziegenhain F, Neuhaus V, Pape HC. Bioactive glass in the treatment of chronic osteomyelitis-a valid option? OTA Int. 2021 Jun 15;4(3 Suppl):e105(1-4). doi: 10.1097/OI9.0000000000000105. eCollection 2021 Jun.

  PMID: 37609479 BACKGROUND

• Waltimo T, Brunner TJ, Vollenweider M, Stark WJ, Zehnder M. Antimicrobial effect of nanometric bioactive glass 45S5. J Dent Res. 2007 Aug;86(8):754-7. doi: 10.1177/154405910708600813.

  PMID: 17652205 BACKGROUND

• Fiume E, Barberi J, Verne E, Baino F. Bioactive Glasses: From Parent 45S5 Composition to Scaffold-Assisted Tissue-Healing Therapies. J Funct Biomater. 2018 Mar 16;9(1):24. doi: 10.3390/jfb9010024.

  PMID: 29547544 BACKGROUND

• Zimmermann G, Moghaddam A. Allograft bone matrix versus synthetic bone graft substitutes. Injury. 2011 Sep;42 Suppl 2:S16-21. doi: 10.1016/j.injury.2011.06.199. Epub 2011 Sep 1.

  PMID: 21889142 BACKGROUND

• Kim WY, Ji JH, Park SE, Kim YY, Jeong JJ, Kang HT. Surgical management of pilon fractures with large segmental bone defects using fibular strut allografts: a report of two cases. Eur J Orthop Surg Traumatol. 2011 Aug;21(6):439-444. doi: 10.1007/s00590-010-0732-3. Epub 2011 Mar 25.

  PMID: 21874131 BACKGROUND

• Meng YC, Zhou XH. External fixation versus open reduction and internal fixation for tibial pilon fractures: A meta-analysis based on observational studies. Chin J Traumatol. 2016 Oct 1;19(5):278-282. doi: 10.1016/j.cjtee.2016.06.002.

  PMID: 27780508 BACKGROUND

• Carter TH, Duckworth AD, Oliver WM, Molyneux SG, Amin AK, White TO. Open Reduction and Internal Fixation of Distal Tibial Pilon Fractures. JBJS Essent Surg Tech. 2019 Sep 11;9(3):e29. doi: 10.2106/JBJS.ST.18.00093. eCollection 2019 Jul-Sep.

  PMID: 32021729 BACKGROUND

• Korkmaz A, Ciftdemir M, Ozcan M, Copuroglu C, Saridogan K. The analysis of the variables, affecting outcome in surgically treated tibia pilon fractured patients. Injury. 2013 Oct;44(10):1270-4. doi: 10.1016/j.injury.2013.06.016. Epub 2013 Jul 18.

  PMID: 23871428 BACKGROUND

• Gustilo RB, Gruninger RP, Davis T. Classification of type III (severe) open fractures relative to treatment and results. Orthopedics. 1987 Dec;10(12):1781-8.

  PMID: 3324085 BACKGROUND

• Bear J, Rollick N, Helfet D. Evolution in Management of Tibial Pilon Fractures. Curr Rev Musculoskelet Med. 2018 Dec;11(4):537-545. doi: 10.1007/s12178-018-9519-7.

  PMID: 30343399 BACKGROUND

• Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D. Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40.

  PMID: 21954749 BACKGROUND

• Kugach KA, Leong WM, Clements JR. Management of Pilon Fractures. Clin Podiatr Med Surg. 2024 Jul;41(3):503-518. doi: 10.1016/j.cpm.2024.01.007. Epub 2024 Feb 28.

  PMID: 38789167 BACKGROUND

Study Officials

• Kyle M Schweser, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki L Jones, MEd

CONTACT

573-882-7583; jonesvicki@health.missouri.edu

Nash Kolb

CONTACT

573-884-8428; kolbn@health.missouri.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF ORTHOPAEDIC SURGERY

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: November 12, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)