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Assessment of the efficacy of the multistage technique in the eradication of infection and achieving the union of traumatic infected femoral un-united shaft fractures in adult patients for one year follow up.
All cases will be treated by the induced membrane technique in two stages. In the first stage, thorough debridement of the infected bone and soft tissues and copious lavage will be done.
After radical debridement, primary fixation will be done by either external fixation or antibiotic cement coated internally fixed implants.If there is a bone defect, it will be measured and filled with an antibiotic-impregnated (PMMA) cement spacer. The second stage procedure will be performed 4 to 8 weeks after the first one if soft tissue permits and only if there is no clinical or biochemical evidence of ongoing infection as indicated by normal white blood cell count, C-reactive protein, and erythrocyte sedimentation rate. It includes the exchange of the antibiotic cement spacer by a cancellous bone graft.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staged approach using antibiotic-cement impregnated PMMA spacer | Procedure | It will be prepared in the following manner. the cement will be mixed with vancomycin in a ratio of 2 gm to each 40 gm of the spacer. The spacer should be shaped into a cylinder before its solidification. The spacer should be as big as possible to fill the whole defect, without compromising the soft tissue and skin closure. Also, cement should wrap the two ends of bone extremities on 2 or 3 centimeters. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the patient-reported clinical outcome as assessed using the WOMAC Osteoarthritis Index from enrollment to 1-year follow-up after the definitive stage. | WOMAC is composed of 24 items over 3 subscales (5 for pain, 2 for stiffness, and 17 for physical function). Participants can rate their difficulty for each item. | from enrollment to one year follow up after the definitive stage. |
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Inclusion Criteria:
Exclusion Criteria:
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adult patient attending the department of orthopedics and traumatology, Assiut university with traumatic infected un-united femoral fractures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael G. Waheeb, Msc ortho | Contact | +201224414404 | michael_ortho_surg@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael G. Waheeb, Msc ortho | Assiut University , 71515 Assiut, Arab Republic of Egypt. | Principal Investigator |
| Osama Farouk, MD ortho | Assiut University , 71515 Assiut, Arab Republic of Egypt. | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19586625 | Background | Prasarn ML, Ahn J, Achor T, Matuszewski P, Lorich DG, Helfet DL. Management of infected femoral nonunions with a single-staged protocol utilizing internal fixation. Injury. 2009 Nov;40(11):1220-5. doi: 10.1016/j.injury.2009.06.009. Epub 2009 Jul 7. | |
| 17375299 | Background | Kinik H, Karaduman M. Cierny-Mader Type III chronic osteomyelitis: the results of patients treated with debridement, irrigation, vancomycin beads and systemic antibiotics. Int Orthop. 2008 Aug;32(4):551-8. doi: 10.1007/s00264-007-0342-9. Epub 2007 Mar 21. |
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| ID | Term |
|---|---|
| D005599 | Fractures, Ununited |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| Hossam MA Abubeih, MD ortho | Assiut University , 71515 Assiut, Arab Republic of Egypt. | Study Director |
| Mahmoud Badran, MD ortho | Assiut University , 71515 Assiut, Arab Republic of Egypt. | Study Director |
| 16364434 | Background | Campoccia D, Montanaro L, Arciola CR. The significance of infection related to orthopedic devices and issues of antibiotic resistance. Biomaterials. 2006 Apr;27(11):2331-9. doi: 10.1016/j.biomaterials.2005.11.044. Epub 2005 Dec 20. |
| 21804411 | Background | Liporace FA, Yoon RS, Frank MA, Gaines RJ, Maurer JP, Polishchuk DL, Choung EW. Use of an "antibiotic plate" for infected periprosthetic fracture in total hip arthroplasty. J Orthop Trauma. 2012 Mar;26(3):e18-23. doi: 10.1097/BOT.0b013e318216dd60. |
| 11835003 | Background | Ohtsuka H, Yokoyama K, Higashi K, Tsutsumi A, Fukushima N, Noumi T, Itoman M. Use of antibiotic-impregnated bone cement nail to treat septic nonunion after open tibial fracture. J Trauma. 2002 Feb;52(2):364-6. doi: 10.1097/00005373-200202000-00025. No abstract available. |
| 25648786 | Background | Micev AJ, Kalainov DM, Soneru AP. Masquelet technique for treatment of segmental bone loss in the upper extremity. J Hand Surg Am. 2015 Mar;40(3):593-8. doi: 10.1016/j.jhsa.2014.12.007. Epub 2015 Jan 31. |
| 28938390 | Background | Masquelet AC. Induced Membrane Technique: Pearls and Pitfalls. J Orthop Trauma. 2017 Oct;31 Suppl 5:S36-S38. doi: 10.1097/BOT.0000000000000979. |
| 20357336 | Background | Blum AL, BongioVanni JC, Morgan SJ, Flierl MA, dos Reis FB. Complications associated with distraction osteogenesis for infected nonunion of the femoral shaft in the presence of a bone defect: a retrospective series. J Bone Joint Surg Br. 2010 Apr;92(4):565-70. doi: 10.1302/0301-620X.92B4.23475. |
| 20656289 | Background | Phillips JR, Trezies AJ, Davis TR. Long-term follow-up of femoral shaft fracture: Relevance of malunion and malalignment for the development of knee arthritis. Injury. 2011 Feb;42(2):156-61. doi: 10.1016/j.injury.2010.06.024. |
| 21915543 | Background | Stannard JP, Bankston L, Futch LA, McGwin G, Volgas DA. Functional outcome following intramedullary nailing of the femur: a prospective randomized comparison of piriformis fossa and greater trochanteric entry portals. J Bone Joint Surg Am. 2011 Aug 3;93(15):1385-91. doi: 10.2106/JBJS.J.00760. |
| Background | Weam F, El-sayed M, Mohamed M. Induced Membrane (Masquelet) Technique for Treatment of Long Bone De-fects. The Medical Journal of Cairo University 2018;86:215-222. |
| Background | Dhanasekhar R, Jacob PJ, Francis J. Antibiotic cement impregnated nailing in the management of infected non-union of femur and tibia. Kerala J Orthop 2013;26:93-97. |
| Background | Cierny G, Mader J. The surgical treatment of adult osteomyelitis. In: Evarts C. Surgery of the Musculoskeletal System, New York, USA: Churchill Livingstone; 1983; 4814-34. |