Tibial Fractures Clinical Trial
Official title:
Open Tibial Shaft Fractures: Can Packing the Exposed Cortex With Intramedullary Reamings Increase Union Rates
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville Hospital | Louisville | Kentucky |
United States | University of Louisville Hospital | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville |
United States,
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. — View Citation
Caudle RJ, Stern PJ. Severe open fractures of the tibia. J Bone Joint Surg Am. 1987 Jul;69(6):801-7. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Return to work status at 6 months post injury | Percentage of patients who had returned to work at 6 months post injury | 6 months | |
Other | Return to work status at 4 months post injury | Percentage of patients who had returned to work at 4 months post injury | 4 months | |
Other | Return to work status at 2 months post injury | Percentage of patients who had returned to work at 2 months post injury | 2 months | |
Primary | 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 | |
Primary | 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 | Lower Extremity Functional Scale Score at 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. | 6 months | |
Secondary | Lower Extremity Functional Scale Score at 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. | 4 months | |
Secondary | Lower Extremity Functional Scale Score at 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. | 2 months |
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