Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment

Hip Fractures Clinical Trial

— AFIF  

Official title:

Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment: A Randomized Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631824
• Other study ID #: HIPFX-001-AUGM
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2015
• Last updated: September 11, 2016
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Hospital Infantil Universitario de San Jose
• Contact: Daniela Sanchez, MD
• Phone: 573108621670
• Email: danielasanchez1989[@]gmail.com
• Is FDA regulated: No
• Health authority: Colombia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Randomized clinical trial to assess if the use of augmentation in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65 years or older 1 year after surgery

Description:

To determine if the use of augmentation with PMMA in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in osteoporotic patients, investigators aim to conduct a multicentered, randomized, single-blinded clinical trial.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• patients arriving to the emergency department after sustaining a fragility hip fracture

• 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:

• polytrauma

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• open reduction and internal fixation
Open reduction and internal fixation using an intramedullary nail

Device:
• 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).

Locations

Country	Name	City	State
Colombia	Fundación Santa Fe de Bogotá	Bogotá
Colombia	Hospital Infantil de San José	Bogotá

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Infantil Universitario de San Jose	Fundación Santa Fe de Bogota

Country where clinical trial is conducted

Colombia, 

References & Publications (17)

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. — View Citation

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. — View Citation

Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. — View Citation

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. — View Citation

DiMaio FR. The science of bone cement: a historical review. Orthopedics. 2002 Dec;25(12):1399-407; quiz 1408-9. Review. — View Citation

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. — View Citation

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. — View Citation

Giannoudis PV, Schneider E. Principles of fixation of osteoporotic fractures. J Bone Joint Surg Br. 2006 Oct;88(10):1272-8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TAD measurement	The TAD will be measured in the immediate postoperative hip x-ray, one month, 3 months, 6 months, and 12 months after the procedure.	immediate postoperative hip x-ray (starting point), at one month, 3 months, 6 months, and 12 months after the procedure.	No
Secondary	Parker Mobility Score	determine the pre-injury level of mobility and evaluate the functional recovery during the follow-up period.	one month, 3 months, 6 months, and 12 months after the procedure.	No
Secondary	EQ-5D Questionnaire	determine the health-related quality of life perceived by the patient, both before the injury and during the follow-up period	one month, 3 months, 6 months, and 12 months after the procedure.	No
Secondary	Pain Visual Analogue Scale	subjective evaluation of pain intensity	one month, 3 months, 6 months, and 12 months after the procedure.	No

External Links

•   link for performing randomization