Outcomes of Hemiarthroplasty Versus Cephalo-medullary Fixation to Treat Unstable Intertrochanteric Femoral Fractures

NCT05134805 | Unknown DMC

• 1 other identifier: FMASU M D 308 2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing functional outcomes of hemiarthroplasty (prosthetic joint) versus cephalo-medullary fixation ( proximal femoral intramedullary nail) in the treatment of unstable intertrochanteric femoral fractures (proximal femur fractures) in elderly people above 60 years old.

Conditions

Fracture of Femur

Keywords

BHA , PFN , HHS

Outcome Measures

Primary Outcomes (2)

• -Harris Hip Score(HHS)

  \- Harris Hip Score(HHS) : scale from 70 to 100 (70-90) . The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result (1). No normative values are available.

  First 3 months post-operative

• -Mobility Score (MS)

  \- Mobility score(MS) : scale from 0 to 3 (0-3) 0 being good mobility and 3 being severely impaired mobility. The higher mobility score, the higher mobility impairment.

  First 3 months post-operative

Secondary Outcomes (2)

• -Harris Hip Score(HHS)

  1 year follow up

• Mobility Score (MS)

  1 year follow up

Study Arms (2)

BHA group

OTHER

Patients will undergo Bipolar hemiarthroplasty operation

Procedure: Bipolar hemiarthroplasty , proximal femoral nail

PFN group

OTHER

Patients will undergo cehphalo-medullary fixation (Proximal femoral nail)

Procedure: Bipolar hemiarthroplasty , proximal femoral nail

Interventions

Bipolar hemiarthroplasty , proximal femoral nail PROCEDURE

* Removal of head of femur , greater trochanter , and lesser trochanter and use bioplar hemiarthroplasty (BHA). * Intra-medullary fixation of intertrchanteric femoral fracture by proximal femoral nail (PFN) Fixation of the fracture by using intramedullary nail(proximal femoral nail).

Also known as: prosthetic joint , fracture fixation

BHA group; PFN group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 60 years old.
• Unstable intertrochanteric femoral fractures

You may not qualify if:

• patient with age less than 60 years old
• Hip osteoarthritis
• Pathological fractures
• Bilateral fractures
• Metabolic bone disease
• Multiple trauma

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams university

Cairo, Abbasia, Egypt

RECRUITING

Related Publications (22)

• Emami M, Manafi A, Hashemi B, Nemati A, Safari S. Comparison of intertrochanteric fracture fixation with dynamic hip screw and bipolar hemiarthroplasty techniques. Arch Bone Jt Surg. 2013 Sep;1(1):14-7. Epub 2013 Sep 15.

  PMID: 25207277 BACKGROUND

• Lindskog DM, Baumgaertner MR. Unstable intertrochanteric hip fractures in the elderly. J Am Acad Orthop Surg. 2004 May-Jun;12(3):179-90. doi: 10.5435/00124635-200405000-00006.

  PMID: 15161171 BACKGROUND

• Blomfeldt R, Tornkvist H, Eriksson K, Soderqvist A, Ponzer S, Tidermark J. A randomised controlled trial comparing bipolar hemiarthroplasty with total hip replacement for displaced intracapsular fractures of the femoral neck in elderly patients. J Bone Joint Surg Br. 2007 Feb;89(2):160-5. doi: 10.1302/0301-620X.89B2.18576.

  PMID: 17322427 BACKGROUND

• Roder F, Schwab M, Aleker T, Morike K, Thon KP, Klotz U. Proximal femur fracture in older patients--rehabilitation and clinical outcome. Age Ageing. 2003 Jan;32(1):74-80. doi: 10.1093/ageing/32.1.74.

  PMID: 12540352 BACKGROUND

• Gupta KL. COMPARATIVE ASSESSMENT OF PRIMARY AND SECONDARY OUTCOME WITH PFNA AND HEMIARTHROPLASTY FOR SENILE INTERTROCHANTERIC FRACTURES MANAGEMENT: A PROSPECTIVE RANDOMIZED CLINICAL STUDY. International Journal of Medical and Biomedical Studies (IJMBS). 2020;4(3):205-8.

  BACKGROUND

• Maru N, Rasik D, Parag T. Unstable intertrochanteric fractures in high risk elderly patients treated with primary bipolar hemiarthroplasty: retrospective case series. Int J Orthop. 2019;5:616-9.

  BACKGROUND

• Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.

  PMID: 5783851 BACKGROUND

• Kokoroghiannis C, Aktselis I, Deligeorgis A, Fragkomichalos E, Papadimas D, Pappadas I. Evolving concepts of stability and intramedullary fixation of intertrochanteric fractures--a review. Injury. 2012 Jun;43(6):686-93. doi: 10.1016/j.injury.2011.05.031. Epub 2011 Jul 14.

  PMID: 21752370 BACKGROUND

• Gaumetou E, Zilber S, Hernigou P. Non-simultaneous bilateral hip fracture: epidemiologic study of 241 hip fractures. Orthop Traumatol Surg Res. 2011 Feb;97(1):22-7. doi: 10.1016/j.otsr.2010.07.011. Epub 2011 Jan 15.

  PMID: 21239241 BACKGROUND

• Han SK, Lee BY, Kim YS, Choi NY. Usefulness of multi-detector CT in Boyd-Griffin type 2 intertrochanteric fractures with clinical correlation. Skeletal Radiol. 2010 Jun;39(6):543-9. doi: 10.1007/s00256-009-0795-6. Epub 2009 Sep 8.

  PMID: 20405284 BACKGROUND

• Setiobudi T, Ng YH, Lim CT, Liang S, Lee K, Das De S. Clinical outcome following treatment of stable and unstable intertrochanteric fractures with dynamic hip screw. Ann Acad Med Singap. 2011 Nov;40(11):482-7.

  PMID: 22206063 BACKGROUND

• Li J, Chen JK, Zhou K, Shen B, Ni XM, Chen L. [Application of dynamic hip screw with modified reamer in intertrochanteric fracture in the elderly]. Zhongguo Gu Shang. 2011 May;24(5):362-5. Chinese.

  PMID: 21688528 BACKGROUND

• Yang YH, Wang YR, Jiang SD, Jiang LS. Proximal femoral nail antirotation and third-generation Gamma nail: which is a better device for the treatment of intertrochanteric fractures? Singapore Med J. 2013 Aug;54(8):446-50. doi: 10.11622/smedj.2013152.

  PMID: 24005451 BACKGROUND

• Haentjens P, Lamraski G. Endoprosthetic replacement of unstable, comminuted intertrochanteric fracture of the femur in the elderly, osteoporotic patient: a review. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1167-80. doi: 10.1080/09638280500055966.

  PMID: 16278186 BACKGROUND

• Zhou S, Liu J, Zhen P, Shen W, Chang Y, Zhang H, Zhu Q, Li X. Proximal femoral nail anti-rotation versus cementless bipolar hemiarthroplasty for unstable femoral intertrochanteric fracture in the elderly: a retrospective study. BMC Musculoskelet Disord. 2019 Oct 29;20(1):500. doi: 10.1186/s12891-019-2793-8.

  PMID: 31664982 BACKGROUND

• Gormeli G, Korkmaz MF, Gormeli CA, Adanas C, Karatas T, Simsek SA. Comparison of femur intertrochanteric fracture fixation with hemiarthroplasty and proximal femoral nail systems. Ulus Travma Acil Cerrahi Derg. 2015 Dec;21(6):503-8. doi: 10.5505/tjtes.2015.96166.

  PMID: 27054643 BACKGROUND

• Jolly A, Bansal R, More AR, Pagadala MB. Comparison of complications and functional results of unstable intertrochanteric fractures of femur treated with proximal femur nails and cemented hemiarthroplasty. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):296-301. doi: 10.1016/j.jcot.2017.09.015. Epub 2017 Sep 29.

  PMID: 30828197 BACKGROUND

• Kesmezacar H, Ogut T, Bilgili MG, Gokay S, Tenekecioglu Y. [Treatment of intertrochanteric femur fractures in elderly patients: internal fixation or hemiarthroplasty]. Acta Orthop Traumatol Turc. 2005;39(4):287-94. Turkish.

  PMID: 16269874 BACKGROUND

• Kim SY, Kim YG, Hwang JK. Cementless calcar-replacement hemiarthroplasty compared with intramedullary fixation of unstable intertrochanteric fractures. A prospective, randomized study. J Bone Joint Surg Am. 2005 Oct;87(10):2186-92. doi: 10.2106/JBJS.D.02768.

  PMID: 16203881 BACKGROUND

• Luo X, He S, Zeng D, Lin L, Li Q. Proximal femoral nail antirotation versus hemiarthroplasty in the treatment of senile intertrochanteric fractures: Case report. Int J Surg Case Rep. 2017;38:37-42. doi: 10.1016/j.ijscr.2017.04.027. Epub 2017 Jul 11.

  PMID: 28734187 BACKGROUND

• Boldin C, Seibert FJ, Fankhauser F, Peicha G, Grechenig W, Szyszkowitz R. The proximal femoral nail (PFN)--a minimal invasive treatment of unstable proximal femoral fractures: a prospective study of 55 patients with a follow-up of 15 months. Acta Orthop Scand. 2003 Feb;74(1):53-8. doi: 10.1080/00016470310013662.

  PMID: 12635794 BACKGROUND

• Papasimos S, Koutsojannis CM, Panagopoulos A, Megas P, Lambiris E. A randomised comparison of AMBI, TGN and PFN for treatment of unstable trochanteric fractures. Arch Orthop Trauma Surg. 2005 Sep;125(7):462-8. doi: 10.1007/s00402-005-0021-5.

  PMID: 16059696 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures

Interventions

Fracture Fixation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mohamed K Asal, MD

  Ain shams university, Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Islam M Soliman, Master

CONTACT

2001007980973; islam.soliman.0089@gmail.com

Ahmed M Mohasseb, MD

CONTACT

2001223533433; Mohasseb80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgery specialist- Principal investigator

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 26, 2021
• Study Start: October 1, 2018
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

EG (1)