Intramedullary Bone Grafting for Open Tibial Shaft Fractures

NCT03891888 | Recruiting

• 1 other identifier: IRB Number: 18.1329
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.

Conditions

Tibial Fractures; Nonunion of Fracture; Delayed Union of Fracture

Keywords

Tibial diaphyseal fracture; Nonunion; Delayed union

Outcome Measures

Primary Outcomes (2)

• Radiographic Union at 6 months

  Percentage of patients with the presence of cortical bridging on at least 3 of the 4 fracture cortices at 6 months

  6 months

• Radiographic Union at 4 months

  Percentage of patients with the presence of cortical bridging on at least 3 of the 4 fracture cortices at 4 months

  4 months

Secondary Outcomes (3)

• Lower Extremity Functional Scale Score at 6 months

  6 months

• Lower Extremity Functional Scale Score at 4 months

  4 months

• Lower Extremity Functional Scale Score at 2 months

  2 months

Other Outcomes (3)

• Return to work status at 6 months post injury

  6 months

• Return to work status at 4 months post injury

  4 months

• Return to work status at 2 months post injury

  2 months

Study Arms (2)

Control

NO INTERVENTION

Patients in this group will undergo standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)

Intervention

EXPERIMENTAL

Patients in this group will receive a bone graft in addition to the undergoing standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing)

Procedure: Intramedullary Bone Graft

Interventions

Intramedullary Bone Graft PROCEDURE

Patients in this group will undergo standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing), but will also have the reamings from the medullary canal preparation collected and packed into the exposed fracture cortex

Intervention

Eligibility Criteria

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

You may qualify if:

• Patient age 18 or older
• Patient with a Gustillo I, II, or IIIa open tibia shaft fracture to be treated primarily with an intramedullary nail
• Primary closure of the open fracture wound during the initial operation
• Consent to participate in the study.
• Are able and willing to return to the hospital or clinic for follow-up for a period of 6-9 months or until radiographic union.

You may not qualify if:

• Patients under the age of 18.
• Patients who are pregnant
• Patients with segmental tibia fractures or those with loss of bone
• Patients with skin defects over the tibia that cannot be closed primarily
• Patients with a pathologic fracture of the tibia
• Patient has quadriplegia or paraplegia

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (2)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (7)

• O'Halloran K, Coale M, Costales T, Zerhusen T Jr, Castillo RC, Nascone JW, O'Toole RV. Will My Tibial Fracture Heal? Predicting Nonunion at the Time of Definitive Fixation Based on Commonly Available Variables. Clin Orthop Relat Res. 2016 Jun;474(6):1385-95. doi: 10.1007/s11999-016-4821-4.

  PMID: 27125823 BACKGROUND

• Riemer BL, DiChristina DG, Cooper A, Sagiv S, Butterfield SL, Burke CJ 3rd, Lucke JF, Schlosser JD. Nonreamed nailing of tibial diaphyseal fractures in blunt polytrauma patients. J Orthop Trauma. 1995 Feb;9(1):66-75. doi: 10.1097/00005131-199502000-00011.

  PMID: 7714657 BACKGROUND

• Sanders R, Jersinovich I, Anglen J, DiPasquale T, Herscovici D Jr. The treatment of open tibial shaft fractures using an interlocked intramedullary nail without reaming. J Orthop Trauma. 1994 Dec;8(6):504-10.

  PMID: 7869165 BACKGROUND

• Caudle RJ, Stern PJ. Severe open fractures of the tibia. J Bone Joint Surg Am. 1987 Jul;69(6):801-7.

  PMID: 3597491 BACKGROUND

• Antonova E, Le TK, Burge R, Mershon J. Tibia shaft fractures: costly burden of nonunions. BMC Musculoskelet Disord. 2013 Jan 26;14:42. doi: 10.1186/1471-2474-14-42.

  PMID: 23351958 BACKGROUND

• Govender S, Csimma C, Genant HK, Valentin-Opran A, Amit Y, Arbel R, Aro H, Atar D, Bishay M, Borner MG, Chiron P, Choong P, Cinats J, Courtenay B, Feibel R, Geulette B, Gravel C, Haas N, Raschke M, Hammacher E, van der Velde D, Hardy P, Holt M, Josten C, Ketterl RL, Lindeque B, Lob G, Mathevon H, McCoy G, Marsh D, Miller R, Munting E, Oevre S, Nordsletten L, Patel A, Pohl A, Rennie W, Reynders P, Rommens PM, Rondia J, Rossouw WC, Daneel PJ, Ruff S, Ruter A, Santavirta S, Schildhauer TA, Gekle C, Schnettler R, Segal D, Seiler H, Snowdowne RB, Stapert J, Taglang G, Verdonk R, Vogels L, Weckbach A, Wentzensen A, Wisniewski T; BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) Study Group. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients. J Bone Joint Surg Am. 2002 Dec;84(12):2123-34. doi: 10.2106/00004623-200212000-00001.

  PMID: 12473698 BACKGROUND

• Dawson J, Kiner D, Gardner W 2nd, Swafford R, Nowotarski PJ. The reamer-irrigator-aspirator as a device for harvesting bone graft compared with iliac crest bone graft: union rates and complications. J Orthop Trauma. 2014 Oct;28(10):584-90. doi: 10.1097/BOT.0000000000000086.

  PMID: 24625833 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures; Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Rodolfo Zamora, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodolfo Zamora, MD

CONTACT

502-629-5460; razamo02@louisville.edu

Salwa M Rashid, MD, MPH

CONTACT

5028526964; sfrash01@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will not know if they are randomized to the control or intervention group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Model Details: Participants will be randomized to either a treatment or control group.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 26, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)