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Intramedullary Bone Grafting for Open Tibial Shaft Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891888
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Rodolfo Zamora, MD, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Tibial Fractures Nonunion of Fracture Delayed Union of Fracture Procedure: Intramedullary Bone Graft Not Applicable

Detailed Description:

Open fractures of the tibial diaphysis are known to have high rates of nonunion or delayed union, with widely varying nonunion rates reported to be between 15% and 60% even in lower Gustilo Anderson grade (types I, II, and IIIA) open fractures. Nonunions are costly as they require more healthcare services and result in increased patient pain and disability. A previous study has demonstrated that the use of bone morphogenic protein (BMP) at the time of definitive tibial shaft fracture fixation significantly reduced the risk of delayed union. However, BMP is costly and is rarely used for this purpose. Intramedullary bone graft (IMBG) collected by the reamer-irrigator-aspirator (RIA) technique has been shown to be effective for producing bone graft to stimulate healing and treat larger defects in long bones as well as in the treatment of nonunions. However, the RIA apparatus also introduces and extra expense to the operation and produces more bone graft than would be needed for packing of the open cortex in non-segmental fractures without bone loss. The investigator's study aims to determine if packing the exposed fracture cortex with a small volume of IMBG collected from the tip of a standard reamer during intramedullary nailing can effectively reduce rate of delayed union and nonunion in open tibia shaft fractures.

This will be a prospective interventional study with two randomized, parallel groups. Patients with an open diaphyseal tibial fracture will be considered for study inclusion. Patients who consent to participate in the study will be randomized to one of two groups. The first will be the control group. This group will receive the standard of care for their injury, which consists of irrigation and debridement of the open fracture, reamed intramedullary nailing and primary wound closure. The second group, the intervention group, will also undergo irrigation and debridement of the open fracture with reamed intramedullary nailing, but will also receive a bone graft on the exposed cortex of the tibial fracture before primarily closing the wound. The bone graft will be made up of the product of the intramedullary reaming prior to the insertion of the intramedullary nail. This bone graft will be collected by wiping the reamings from the reamer tip into a sterile, pre-weighed container after each pass of the reamer through the medullary canal. Prior to introducing the graft into the exposed cortex, the graft will be weighed so that a record may be kept of the amount of graft collected and subsequently used in the procedure.

Each group will then receive identical follow-up care with clinic visits at 2, 8, 16, and 24 weeks post operatively, and will receive X-rays at the 8, 16, and 24 week visits. Each radiograph will be evaluated and assigned a Radiographic Union Scale in Tibial fractures (RUST) score by an independent evaluator. Additionally, the Lower Extremity Functional Scale (LEFS) questionnaire will be administered at enrollment, 8, 16, and 24 week visit to objectively measure patient progress in functional outcomes. The primary outcome measurement will be the rate of union of the fracture in both groups at 3 and 6 month follow up. Radiographic union of the fracture will be defined as the presence of cortical bridging on at least 3 of the 4 cortices or RUST score >10. Delayed union will be defined as failure to achieve cortical bridging on 3 of 4 cortices or a RUST score >10 by 6 months. Nonunion will be defined as a fracture that in the opinion of the treating surgeon has no possibility of healing without further intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either a treatment or control group.
Masking: Single (Participant)
Masking Description: Patient will not know if they are randomized to the control or intervention group
Primary Purpose: Prevention
Official Title: Open Tibial Shaft Fractures: Can Packing the Exposed Cortex With Intramedullary Reamings Increase Union Rates
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
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)
Experimental: Intervention
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
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




Primary Outcome Measures :
  1. Radiographic Union at 6 months [ Time Frame: 6 months ]
    Percentage of patients with the presence of cortical bridging on at least 3 of the 4 fracture cortices at 6 months

  2. Radiographic Union at 4 months [ Time Frame: 4 months ]
    Percentage of patients with the presence of cortical bridging on at least 3 of the 4 fracture cortices at 4 months


Secondary Outcome Measures :
  1. Lower Extremity Functional Scale Score at 6 months [ Time Frame: 6 months ]
    The Lower Extremity Functional Scale Score is a patient reported outcome measure that can be used clinically to measure initial function, ongoing progress, and outcomes in patients with impairment of the lower extremities due to musculoskeletal conditions or disorders. The test assesses activities of daily living, balance, coordination, functional mobility, occupational performance, quality of life, range of motion, and strength, and is scored out of 80 points. The minimum possible score is 0 and the maximum possible score is 80, with a higher score associated with better outcomes. The minimum clinically important difference for this scale is 9 points.

  2. Lower Extremity Functional Scale Score at 4 months [ Time Frame: 4 months ]
    The Lower Extremity Functional Scale Score is a patient reported outcome measure that can be used clinically to measure initial function, ongoing progress, and outcomes in patients with impairment of the lower extremities due to musculoskeletal conditions or disorders. The test assesses activities of daily living, balance, coordination, functional mobility, occupational performance, quality of life, range of motion, and strength, and is scored out of 80 points. The minimum possible score is 0 and the maximum possible score is 80, with a higher score associated with better outcomes. The minimum clinically important difference for this scale is 9 points.

  3. Lower Extremity Functional Scale Score at 2 months [ Time Frame: 2 months ]
    The Lower Extremity Functional Scale Score is a patient reported outcome measure that can be used clinically to measure initial function, ongoing progress, and outcomes in patients with impairment of the lower extremities due to musculoskeletal conditions or disorders. The test assesses activities of daily living, balance, coordination, functional mobility, occupational performance, quality of life, range of motion, and strength, and is scored out of 80 points. The minimum possible score is 0 and the maximum possible score is 80, with a higher score associated with better outcomes. The minimum clinically important difference for this scale is 9 points.


Other Outcome Measures:
  1. Return to work status at 6 months post injury [ Time Frame: 6 months ]
    Percentage of patients who had returned to work at 6 months post injury

  2. Return to work status at 4 months post injury [ Time Frame: 4 months ]
    Percentage of patients who had returned to work at 4 months post injury

  3. Return to work status at 2 months post injury [ Time Frame: 2 months ]
    Percentage of patients who had returned to work at 2 months post injury



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891888


Contacts
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Contact: Rodolfo Zamora, MD 502-629-5460 razamo02@louisville.edu
Contact: Lauren M Nelson, MD 831-535-3397 lmgerm01@louisville.edu

Locations
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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40228
Contact: Rodolfo Zamora, MD    502-629-5460    razamo02@louisville.edu   
Contact: Lauren M Nelson, MD    831-535-3397    lmgerm01@louisville.edu   
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Rodolfo Zamora, MD University of Louisville
Publications:
Govender S, Csimma C, Genant HK, Valentin-Opran A, Amit Y, Arbel R, Aro H, Atar D, Bishay M, Börner 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, Rüter 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.

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Responsible Party: Rodolfo Zamora, MD, Assistant Professor of Orthopaedic Surgery, University of Louisville
ClinicalTrials.gov Identifier: NCT03891888    
Other Study ID Numbers: IRB Number: 18.1329
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodolfo Zamora, MD, University of Louisville:
Tibial diaphyseal fracture
Nonunion
Delayed union
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Fractures, Ununited
Wounds and Injuries
Leg Injuries