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

About this trial
This is an interventional treatment trial for Proximal Femur Fracture focused on measuring Dynamic Hip Screw, DHS HIP FRACTURE
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
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
NCT ID
NCT05091359
First Posted
September 3, 2021
Last Updated
October 12, 2021
Sponsor
Hospital Regional Tlalnepantla
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
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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
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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
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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
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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
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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
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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
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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.
Results Reference
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Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold.
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