Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment
NCT ID: NCT02631824
Last Updated: 2016-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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Detailed Description
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All patients aged 65 years or older arriving to the emergency department of two level-1 trauma centers in Bogotá, Colombia; Hospital Universitario Fundación Santa Fe de Bogotá and Hospital Infantil Universitario de San José, after sustaining a fragility intertrochanteric hip fracture that requires open reduction and internal fixation (ORIF) will be included. These patients must be willing to accept a 1-year follow-up and are required to sign an informed consent agreeing to their participation in the study. For the sample calculation a two-tailed analysis with an alpha-level of significance of 0.05, a power of 80% (β = 0.2) was performed. A total of 35 patients per group plus a 30% increase to control for loss of follow-up was calculated. This gives a total of 90 patients; 45 patients per group.
Patients meeting inclusion and exclusion criteria will be recruited by convenience sampling as they arrive to the emergency department.
Once included in the study, patients will be stratified by age into two groups: patients aged between 65-85 years and patients over 85 years. Then, by using a block randomization, the intervention (augmentation) will be randomly allocated in order to divide the sample population into an intervention group (ORIF + augmentation with PMMA) and a control group (ORIF without augmentation). Randomization will be carried out by the program "Sealed Envelope" (https://www.sealedenvelope.com) that generates a list with codes (each code representing one patient) and randomly assigns them to either the intervention or the control group. This list will be in custody of a research assistant who will not have any contact with patients during the trial's duration and will be in charge of writing the allocation of each code into a sealed, opaque envelope. Each envelope will be given to the surgeon during the procedure at the precise moment where augmentation is needed, revealing whether or not augmentation should be performed. Medical care will be based on Orthogeriatric Programs and surgeries will be performed by orthopaedic surgeons with a clinical fellowship in Orthopaedic Trauma. Patients will be blinded to treatment and will be seen on follow-up visits 15 days, one month, 3 months, 6 months, and 12 months after the procedure.
The primary outcome will be the change in TAD measurement 1 year after the surgical procedure. The functional differences between both groups will be measured as secondary outcomes. Outcomes (primary and secondary) will be measured during follow-up visits one month, 3 months, 6 months, and 12 months after the procedure.
Results will be analyzed using STATA ® Data Analysis and Statistical Software, version 13.1. The sample's demographic and baseline characteristics will be described using descriptive statistics. Continuous variables will be reported as arithmetic means while categorical variables will be reported as absolute values of frequencies and distribution. For the inferential analysis of the results, a Shapiro Wilk W-Test will be used to determine normality distribution of values. If normality assumptions are met, the change in TAD measurement will be analyzed with a student t-test. If not, its non-parametric analogue (Mann-Whitney U-test) will be used. For all other categorical variables, a X2 or Fisher's exact test will be used.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard treatment
open reduction and internal fixation TFNA
open reduction and internal fixation
Open reduction and internal fixation using an intramedullary nail
TFNA
Trochanteric Femoral Nail Advance
Augmentation
open reduction and internal fixation TFNA Augmentation (Cement)
open reduction and internal fixation
Open reduction and internal fixation using an intramedullary nail
TFNA
Trochanteric Femoral Nail Advance
Augmentation (Cement)
Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).
Interventions
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open reduction and internal fixation
Open reduction and internal fixation using an intramedullary nail
TFNA
Trochanteric Femoral Nail Advance
Augmentation (Cement)
Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).
Eligibility Criteria
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Inclusion Criteria
* radiographic diagnosis of intertrochanteric fracture requiring open reduction and internal fixation
* patient willing to accept a 1-year follow-up
* signature of informed consent
Exclusion Criteria
* patients with a non-fragility hip fracture (high-energy trauma)
* hip fractures due to primary or metastatic tumours,
* open or periprosthetic hip fractures
* patients with history of organ transplantation and patients with severe dementia.
* patients with iatrogenic perforation into the hip joint during procedure
65 Years
ALL
No
Sponsors
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Fundación Santa Fe de Bogota
OTHER
Hospital Infantil Universitario de San Jose
OTHER
Responsible Party
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Carlos Mario Olarte
Head of Orthopedics Department at HIUSJ
Principal Investigators
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Carlos M Olarte, MD
Role: PRINCIPAL_INVESTIGATOR
Head of Orthopaedic Department at Hospital Infantil de San José
Locations
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Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., Colombia
Hospital Infantil de San José
Bogotá, Bogota D.C., Colombia
Countries
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Central Contacts
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Facility Contacts
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References
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Kammerlander C, Erhart S, Doshi H, Gosch M, Blauth M. Principles of osteoporotic fracture treatment. Best Pract Res Clin Rheumatol. 2013 Dec;27(6):757-69. doi: 10.1016/j.berh.2014.02.005.
Simunovic N, Devereaux PJ, Sprague S, Guyatt GH, Schemitsch E, Debeer J, Bhandari M. Effect of early surgery after hip fracture on mortality and complications: systematic review and meta-analysis. CMAJ. 2010 Oct 19;182(15):1609-16. doi: 10.1503/cmaj.092220. Epub 2010 Sep 13.
Friedman SM, Mendelson DA, Kates SL, McCann RM. Geriatric co-management of proximal femur fractures: total quality management and protocol-driven care result in better outcomes for a frail patient population. J Am Geriatr Soc. 2008 Jul;56(7):1349-56. doi: 10.1111/j.1532-5415.2008.01770.x. Epub 2008 May 22.
Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
Giannoudis PV, Schneider E. Principles of fixation of osteoporotic fractures. J Bone Joint Surg Br. 2006 Oct;88(10):1272-8. doi: 10.1302/0301-620X.88B10.17683.
Moroni A, Larsson S, Hoang Kim A, Gelsomini L, Giannoudis PV. Can we improve fixation and outcomes? Use of bone substitutes. J Orthop Trauma. 2009 Jul;23(6):422-5. doi: 10.1097/BOT.0b013e3181771426.
Kammerlander C, Gebhard F, Meier C, Lenich A, Linhart W, Clasbrummel B, Neubauer-Gartzke T, Garcia-Alonso M, Pavelka T, Blauth M. Standardised cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicentre trial. Injury. 2011 Dec;42(12):1484-90. doi: 10.1016/j.injury.2011.07.010. Epub 2011 Aug 19.
Kammerlander C, Doshi H, Gebhard F, Scola A, Meier C, Linhart W, Garcia-Alonso M, Nistal J, Blauth M. Long-term results of the augmented PFNA: a prospective multicenter trial. Arch Orthop Trauma Surg. 2014 Mar;134(3):343-9. doi: 10.1007/s00402-013-1902-7. Epub 2013 Dec 3.
Sermon A, Hofmann-Fliri L, Richards RG, Flamaing J, Windolf M. Cement augmentation of hip implants in osteoporotic bone: how much cement is needed and where should it go? J Orthop Res. 2014 Mar;32(3):362-8. doi: 10.1002/jor.22522. Epub 2013 Nov 20.
Eriksson F, Mattsson P, Larsson S. The effect of augmentation with resorbable or conventional bone cement on the holding strength for femoral neck fracture devices. J Orthop Trauma. 2002 May;16(5):302-10. doi: 10.1097/00005131-200205000-00003.
Augat P, Rapp S, Claes L. A modified hip screw incorporating injected cement for the fixation of osteoporotic trochanteric fractures. J Orthop Trauma. 2002 May;16(5):311-6. doi: 10.1097/00005131-200205000-00004.
Mattsson P, Larsson S. Unstable trochanteric fractures augmented with calcium phosphate cement. A prospective randomized study using radiostereometry to measure fracture stability. Scand J Surg. 2004;93(3):223-8. doi: 10.1177/145749690409300310.
Lee PC, Hsieh PH, Chou YC, Wu CC, Chen WJ. Dynamic hip screws for unstable intertrochanteric fractures in elderly patients--encouraging results with a cement augmentation technique. J Trauma. 2010 Apr;68(4):954-64. doi: 10.1097/TA.0b013e3181c995ec.
Dall'Oca C, Maluta T, Moscolo A, Lavini F, Bartolozzi P. Cement augmentation of intertrochanteric fractures stabilised with intramedullary nailing. Injury. 2010 Nov;41(11):1150-5. doi: 10.1016/j.injury.2010.09.026. Epub 2010 Oct 6.
Baumgaertner MR, Solberg BD. Awareness of tip-apex distance reduces failure of fixation of trochanteric fractures of the hip. J Bone Joint Surg Br. 1997 Nov;79(6):969-71. doi: 10.1302/0301-620x.79b6.7949.
Rubio-Avila J, Madden K, Simunovic N, Bhandari M. Tip to apex distance in femoral intertrochanteric fractures: a systematic review. J Orthop Sci. 2013 Jul;18(4):592-8. doi: 10.1007/s00776-013-0402-5. Epub 2013 May 2.
DiMaio FR. The science of bone cement: a historical review. Orthopedics. 2002 Dec;25(12):1399-407; quiz 1408-9. doi: 10.3928/0147-7447-20021201-21.
Related Links
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link for performing randomization
Other Identifiers
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HIPFX-001-AUGM
Identifier Type: -
Identifier Source: org_study_id
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