NCT04681846

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

December 11, 2020

Last Update Submit

December 20, 2020

Conditions

Fracture Non Union

Keywords

infected non-union

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Staged approach using antibiotic-cement impregnated PMMA spacerPROCEDURE

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patient attending the department of orthopedics and traumatology, Assiut university with traumatic infected un-united femoral fractures.

You may qualify if:

  • Age between 18 and 65 years old.
  • Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults.

You may not qualify if:

  • Patients with deficient soft tissue coverage with exposed bone.
  • Patients with reflex sympathetic dystrophy.
  • Spinal injuries associated with neurological complications affecting the lower limbs.
  • Associated head injury affecting the conscious level or the motor power of the injured limb.
  • Associated mutilating limb injury or peripheral amputation.
  • Bone defect more than 6 cm in length.
  • Chronic peripheral ischemia of the limb.
  • Past history of pathological fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 19586625BACKGROUND

  • 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.

    PMID: 17375299BACKGROUND

  • 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.

    PMID: 16364434BACKGROUND

  • 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.

    PMID: 21804411BACKGROUND

  • 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.

    PMID: 11835003BACKGROUND

  • 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.

    PMID: 25648786BACKGROUND

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

    PMID: 28938390BACKGROUND

  • 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.

    PMID: 20357336BACKGROUND

  • 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.

    PMID: 20656289BACKGROUND

  • 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.

    PMID: 21915543BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • 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

  • 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

Central Study Contacts

Michael G. Waheeb, Msc ortho

CONTACT

+201224414404michael_ortho_surg@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 23, 2020

Study Start

March 1, 2021

Primary Completion

August 1, 2022

Study Completion

October 1, 2022

Last Updated

December 23, 2020

Record last verified: 2020-12