NCT02631824

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

December 5, 2015

Last Update Submit

September 11, 2016

Conditions

Hip Fractures

Keywords

fragility fractureship fracturesaugmentationtip-apex distance

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Parker Mobility Score

    one month, 3 months, 6 months, and 12 months after the procedure.

  • EQ-5D Questionnaire

    one month, 3 months, 6 months, and 12 months after the procedure.

  • Pain Visual Analogue Scale

    one month, 3 months, 6 months, and 12 months after the procedure.

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

open reduction and internal fixation TFNA

Procedure: open reduction and internal fixationDevice: TFNA

Augmentation

EXPERIMENTAL

open reduction and internal fixation TFNA Augmentation (Cement)

Procedure: open reduction and internal fixationDevice: TFNADevice: Augmentation (Cement)

Interventions

open reduction and internal fixationPROCEDURE

Open reduction and internal fixation using an intramedullary nail

AugmentationStandard treatment
TFNADEVICE

Trochanteric Femoral Nail Advance

AugmentationStandard treatment
Augmentation (Cement)DEVICE

Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).

Augmentation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia

RECRUITING

Hospital Infantil de San José

Bogotá, Bogota D.C., Colombia

RECRUITING

Related Publications (17)

  • 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.

    PMID: 24836334BACKGROUND

  • 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.

    PMID: 20837683BACKGROUND

  • 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.

    PMID: 18503520BACKGROUND

  • 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.

    PMID: 1421796BACKGROUND

  • 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.

    PMID: 17012413BACKGROUND

  • 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.

    PMID: 19550228BACKGROUND

  • 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.

    PMID: 21855063BACKGROUND

  • 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.

    PMID: 24297215BACKGROUND

  • 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.

    PMID: 24259367BACKGROUND

  • 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.

    PMID: 11972072BACKGROUND

  • 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.

    PMID: 11972073BACKGROUND

  • 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.

    PMID: 15544079BACKGROUND

  • 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.

    PMID: 20386288BACKGROUND

  • 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.

    PMID: 20932521BACKGROUND

  • 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.

    PMID: 9393914BACKGROUND

  • 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.

    PMID: 23636573BACKGROUND

  • 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.

    PMID: 12502206BACKGROUND

Related Links

MeSH Terms

Conditions

Hip Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Carlos M Olarte, MD

    Head of Orthopaedic Department at Hospital Infantil de San José

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Sanchez, MD

CONTACT

573108621670danielasanchez1989@gmail.com

Carlos M Olarte, MD

CONTACT

573158546947cmolarte@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Orthopedics Department at HIUSJ

Study Record Dates

First Submitted

December 5, 2015

First Posted

December 16, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)