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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.
The intertrochanteric femoral fractures incidence rate has increased through the last years because of increasing life expectancy, leading to more morbidity and mortality rates . Unstable fracture pattern occurs due to age increase and bone quality decrease. Unstable intertrochanteric femoral fractures (ITFF) are considered about 40-45% of hip fractures in elderly people . Of note, 55% of these fractures had unstable patterns . The main objective of treatment is to restore the patients to their preoperative daily activities and medical conditions .
Therefore, the surgical treatment aims to return the patient to his pre-fracture level of activity to ensure that the patient moves as soon as possible to prevent complications due to immobility which can lead to death.
In an unstable fracture pattern which is characterized by decreased bone quality, it is of great importance to providing efficient and proper treatment . A lot of treatment modalities had been used in the treatment of this fracture pattern such as PFN, unipolar hemiarthroplasty, BHA, and dynamic hip screw (DHS) . On the other hand, it is difficult to perform stable fixation owing to osteoporotic bone quality.
The treatment aims to restore the patient's ambulation and decrease medical complications and technical failure. By using either BHA or PFN methods, patients can return to pre-injury levels decreasing complications induced by prolonged immobilization or implant failure .
The primary objective of the current study is to compare functional outcomes of unstable ITFF managed by PFN or BHA among cases with ages more than 60 years old. The second main objective is to compare intraoperative and postoperative in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHA group | Other | Patients will undergo Bipolar hemiarthroplasty operation |
|
| PFN group | Other | Patients will undergo cehphalo-medullary fixation (Proximal femoral nail) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar hemiarthroplasty , proximal femoral nail | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| -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 |
| Measure | Description | Time Frame |
|---|---|---|
| -Harris Hip Score(HHS) | - Harris hip score (HHS): scale from 70 to 100 (70-100). 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. | 1 year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Islam M Soliman, Master | Contact | 2001007980973 | islam.soliman.0089@gmail.com | |
| Ahmed M Mohasseb, MD | Contact | 2001223533433 | Mohasseb80@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed K Asal, MD | Ain shams university, Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain Shams university | Recruiting | Cairo | Abbasia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25207277 | Background | 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. | |
| 15161171 | 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. |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
|
| 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. |
| 1 year follow up |
| 17322427 | 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. |
| 12540352 | 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. |
| 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. |
| 5783851 | 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. |
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| 21239241 | 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. |
| 20405284 | 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. |
| 22206063 | 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. |
| 21688528 | 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. |
| 24005451 | 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. |
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| 27054643 | 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. |
| 30828197 | 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. |
| 16269874 | 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. |
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| 16059696 | 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. |