Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults

Fracture Non Union Clinical Trial

Official title:

Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04681846
• Other study ID #: Fracture-related infection
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: October 2022

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: Michael G. Waheeb, Msc ortho
• Phone: +201224414404
• Email: michael_ortho_surg[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 65 years old.

2. Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults.

Exclusion Criteria:

1. Patients with deficient soft tissue coverage with exposed bone.

2. Patients with reflex sympathetic dystrophy.

3. Spinal injuries associated with neurological complications affecting the lower limbs.

4. Associated head injury affecting the conscious level or the motor power of the injured limb.

5. Associated mutilating limb injury or peripheral amputation.

6. Bone defect more than 6 cm in length.

7. Chronic peripheral ischemia of the limb.

8. Past history of pathological fractures.

Related Conditions & MeSH terms

• Fracture Non Union
• Fractures, Bone
• Fractures, Ununited

Intervention

Procedure:
• Staged approach using antibiotic-cement impregnated PMMA spacer
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

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. — View Citation

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. Epub 2005 Dec 20. Review. — View Citation

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.

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.

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. Epub 2007 Mar 21. — View Citation

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. — View Citation

Masquelet AC. Induced Membrane Technique: Pearls and Pitfalls. J Orthop Trauma. 2017 Oct;31 Suppl 5:S36-S38. doi: 10.1097/BOT.0000000000000979. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.