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Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold. (geneX)

Primary Purpose

Proximal Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste
Sponsored by
Hospital Regional Tlalnepantla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Femur Fracture focused on measuring Dynamic Hip Screw, DHS HIP FRACTURE

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between 65 and 80 years old
  • Patients classified as 31A1.3 and all 31A2 by the Orthopaedic Trauma Association classification system.

Exclusion Criteria:

  • Patients with stable hip fractures
  • Participants who do not accept the randomization process
  • patients who do not complete follow-up during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study group

    Control Group

    Arm Description

    Participants in which absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste at the time of the placement of the hip implant to prevent loosening of it's unstable trans-trochanteric fractures of the proximal femur, were applied.

    Participants without application of graft during hip implant.

    Outcomes

    Primary Outcome Measures

    Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
    The aim of this study is to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw to improve implant integration and bone healing.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2021
    Last Updated
    October 12, 2021
    Sponsor
    Hospital Regional Tlalnepantla
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05091359
    Brief Title
    Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold.
    Acronym
    geneX
    Official Title
    Unstable Proximal Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and ß -Tricalcium Phosphate/ Hemihydrated Calcium Sulfate Graft Scaffold
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (Actual)
    Primary Completion Date
    June 1, 2018 (Actual)
    Study Completion Date
    May 10, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Regional Tlalnepantla

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomised prospective comparison study to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw for improvement of the implant stability integration and bone healing.
    Detailed Description
    Transtrochanteric fractures are a frequent entity, mainly in patients over 65 years old, with low bone density. Most of these fractures of the proximal femur are treated effectively with internal fixation with dynamic hip screw (DHS), nonetheless a conditional factor in the treatment success its in the fracture stability and in the osteoporosis severity. There is controversy in the treatment decision in patients with osteoporosis and an unstable fracture added the risk of peri-prosthetic infection or increased bleeding during surgery means that the decision to place a DHS versus a prosthesis is debated. This study represents the first comparison of closed reduction and internal fixation with DHS using calcium sulfate graft versus conventional DHS procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proximal Femur Fracture
    Keywords
    Dynamic Hip Screw, DHS HIP FRACTURE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A two group comparison
    Masking
    Participant
    Masking Description
    The procedure was elected by participant randomization.
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Participants in which absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste at the time of the placement of the hip implant to prevent loosening of it's unstable trans-trochanteric fractures of the proximal femur, were applied.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Participants without application of graft during hip implant.
    Intervention Type
    Device
    Intervention Name(s)
    Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste
    Intervention Description
    Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant
    Primary Outcome Measure Information:
    Title
    Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
    Description
    The aim of this study is to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw to improve implant integration and bone healing.
    Time Frame
    12 weeks for each patient

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients between 65 and 80 years old Patients classified as 31A1.3 and all 31A2 by the Orthopaedic Trauma Association classification system. Exclusion Criteria: Patients with stable hip fractures Participants who do not accept the randomization process patients who do not complete follow-up during the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JULIO C VELEZ, mD
    Organizational Affiliation
    HEAD OF THE ORTHOPEDIC SERVICE OF THE REGIONAL HOSPITAL TLALNEPANTLA ISSEMYM
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    SILVIA S SERRANO REYES, MD
    Organizational Affiliation
    JOINT SURGERY RESIDENT
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25386578
    Citation
    Hassankhani EG, Omidi-Kashani F, Hajitaghi H, Hassankhani GG. How to Treat the Complex Unstable Intertrochanteric Fractures in Elderly Patients? DHS or Arthroplasty. Arch Bone Jt Surg. 2014 Sep;2(3):174-9. Epub 2014 Sep 15.
    Results Reference
    background
    PubMed Identifier
    26178894
    Citation
    Brox WT, Roberts KC, Taksali S, Wright DG, Wixted JJ, Tubb CC, Patt JC, Templeton KJ, Dickman E, Adler RA, Macaulay WB, Jackman JM, Annaswamy T, Adelman AM, Hawthorne CG, Olson SA, Mendelson DA, LeBoff MS, Camacho PA, Jevsevar D, Shea KG, Bozic KJ, Shaffer W, Cummins D, Murray JN, Donnelly P, Shores P, Woznica A, Martinez Y, Boone C, Gross L, Sevarino K. The American Academy of Orthopaedic Surgeons Evidence-Based Guideline on Management of Hip Fractures in the Elderly. J Bone Joint Surg Am. 2015 Jul 15;97(14):1196-9. doi: 10.2106/JBJS.O.00229. No abstract available.
    Results Reference
    background
    PubMed Identifier
    28379914
    Citation
    Quinn RH, Mooar PA, Murray JN, Pezold R, Sevarino KS. Treatment of Hip Fractures in the Elderly. J Am Acad Orthop Surg. 2017 May;25(5):e102-e104. doi: 10.5435/JAAOS-D-16-00431.
    Results Reference
    background
    PubMed Identifier
    25478376
    Citation
    Singh S, Shrivastava C, Kumar S. Hemi replacement arthroplasty for unstable inter-trochanteric fractures of femur. J Clin Diagn Res. 2014 Oct;8(10):LC01-4. doi: 10.7860/JCDR/2014/10171.4972. Epub 2014 Oct 20.
    Results Reference
    background
    PubMed Identifier
    25230266
    Citation
    Kim Y, Moon JK, Hwang KT, Choi IY, Kim YH. Cementless bipolar hemiarthroplasty for unstable intertrochanteric fractures in octogenarians. Acta Orthop Traumatol Turc. 2014;48(4):424-30. doi: 10.3944/AOTT.2014.13.0119.
    Results Reference
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    PubMed Identifier
    25274786
    Citation
    Swart E, Makhni EC, Macaulay W, Rosenwasser MP, Bozic KJ. Cost-effectiveness analysis of fixation options for intertrochanteric hip fractures. J Bone Joint Surg Am. 2014 Oct 1;96(19):1612-20. doi: 10.2106/JBJS.M.00603.
    Results Reference
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    PubMed Identifier
    25046412
    Citation
    Kregor PJ, Obremskey WT, Kreder HJ, Swiontkowski MF. Unstable pertrochanteric femoral fractures. J Orthop Trauma. 2014 Aug;28 Suppl 8:S25-8. doi: 10.1097/BOT.0000000000000187.
    Results Reference
    background
    PubMed Identifier
    22810396
    Citation
    De Bruijn K, den Hartog D, Tuinebreijer W, Roukema G. Reliability of predictors for screw cutout in intertrochanteric hip fractures. J Bone Joint Surg Am. 2012 Jul 18;94(14):1266-72. doi: 10.2106/JBJS.K.00357.
    Results Reference
    background
    PubMed Identifier
    19784649
    Citation
    Hsueh KK, Fang CK, Chen CM, Su YP, Wu HF, Chiu FY. Risk factors in cutout of sliding hip screw in intertrochanteric fractures: an evaluation of 937 patients. Int Orthop. 2010 Dec;34(8):1273-6. doi: 10.1007/s00264-009-0866-2. Epub 2009 Sep 26. Erratum In: Int Orthop. 2012 Jan;36(1):215.
    Results Reference
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    PubMed Identifier
    9581243
    Citation
    Wu CC, Shih CH, Chen WJ, Tai CL. Treatment of cutout of a lag screw of a dynamic hip screw in an intertrochanteric fracture. Arch Orthop Trauma Surg. 1998;117(4-5):193-6. doi: 10.1007/s004020050228.
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    PubMed Identifier
    28802425
    Citation
    Puram C, Pradhan C, Patil A, Sodhai V, Sancheti P, Shyam A. Outcomes of dynamic hip screw augmented with trochanteric wiring for treatment of unstable type A2 intertrochanteric femur fractures. Injury. 2017 Aug;48 Suppl 2:S72-S77. doi: 10.1016/S0020-1383(17)30498-9.
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    PubMed Identifier
    25245650
    Citation
    Valentini R, Martino M, Piovan G, De Fabrizio G, Fancellu G. Proximal cut-out in pertrochanteric femural fracture. Acta Biomed. 2014 Aug 20;85(2):144-51.
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    Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold.

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