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

Proximal Femur Fracture Clinical Trial

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Official title:

Unstable Proximal Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and ß -Tricalcium Phosphate/ Hemihydrated Calcium Sulfate Graft Scaffold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091359
• Other study ID #: 02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: May 10, 2019

Study information

• Verified date: October 2021
• Source: Hospital Regional Tlalnepantla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 10, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Proximal Femur Fracture

Intervention

Device:
• Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste
Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional Tlalnepantla

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks for each patient