Fracture Non UnionNCT04681846
Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults
An observational study of Fracture Non Union, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fracture Non Union
- What is being tested?
- Staged approach using antibiotic-cement impregnated PMMA spacer
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patient attending the department of orthopedics and traumatology, Assiut university with traumatic infected un-united femoral fractures.
Who may be able to join
- Age between 18 and 65 years old.
- Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Fracture Non Union
- Being tested
- Staged approach using antibiotic-cement impregnated PMMA spacer
- Keywords
- infected non-union
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged approach using antibiotic-cement impregnated PMMA spacerProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to one year follow up after the definitive stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study startMar 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Fracture Non UnionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Girgis Waheeb Tawfeek, Assiut University
- Investigators
- Michael G. Waheeb, Msc ortho, Principal investigator, Assiut University , 71515 Assiut, Arab Republic of Egypt.Osama Farouk, MD ortho, Study chair, Assiut University , 71515 Assiut, Arab Republic of Egypt.Hossam MA Abubeih, MD ortho, Study director, Assiut University , 71515 Assiut, Arab Republic of Egypt.Mahmoud Badran, MD ortho, Study director, Assiut University , 71515 Assiut, Arab Republic of Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681846
- Sponsor's protocol ID
- Fracture-related infection
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19586625Kinik 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.
PubMed 17375299Campoccia 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.
PubMed 16364434Liporace 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.
PubMed 21804411Ohtsuka 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.
PubMed 11835003Micev 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.
PubMed 25648786Masquelet AC. Induced Membrane Technique: Pearls and Pitfalls. J Orthop Trauma. 2017 Oct;31 Suppl 5:S36-S38. doi: 10.1097/BOT.0000000000000979.
PubMed 28938390Blum 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.
PubMed 20357336Phillips 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.
PubMed 20656289Stannard 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.
PubMed 21915543Weam 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.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults
- ClinicalTrials.gov ID
- NCT04681846
- Acronym / sponsor ID
- Fracture-related infection
- Conditions
- Fracture Non Union
- Keywords
- infected non-union
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patient attending the department of orthopedics and traumatology, Assiut university with traumatic infected un-united femoral fractures.
Key inclusion criteria (2 listed)
- Age between 18 and 65 years old.
- Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staged approach using antibiotic-cement impregnated PMMA spacerIt 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. | Procedure or surgery | – |
Primary outcome
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.
Time frame: from enrollment to one 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 19586625Prasarn 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.
- Background: PubMed 17375299Kinik 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.
- Background: PubMed 16364434Campoccia 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.
- Background: PubMed 21804411Liporace 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.
- Background: PubMed 11835003Ohtsuka 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.
- Background: PubMed 25648786Micev 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.
- Background: PubMed 28938390Masquelet AC. Induced Membrane Technique: Pearls and Pitfalls. J Orthop Trauma. 2017 Oct;31 Suppl 5:S36-S38. doi: 10.1097/BOT.0000000000000979.
- Background: PubMed 20357336Blum 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.
- Background: PubMed 20656289Phillips 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.
- Background: PubMed 21915543Stannard 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.
- BackgroundWeam 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.
- BackgroundDhanasekhar 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.
- Individual participant dataSharing planned: Undecided
Related trials for Fracture Non Union
Not yet recruiting
Allograft vs. Autograft Nonunion
Nonunion Fracture
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
RecruitingObservational study
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Fractures, Bone, Nonunion of Fracture
RecruitingPhase 3
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Infections, Infected Wound
Active, not recruiting
Modern Methods of Treatment and Diagnosis of Patients With Injuries and Diseases of the Musculoskeletal System
Osteoarthritis, Knee, Fractures, Ununited
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G. Waheeb, Msc ortho principal investigator
Assiut University , 71515 Assiut, Arab Republic of Egypt.
Osama Farouk, MD ortho study chair
Assiut University , 71515 Assiut, Arab Republic of Egypt.
Hossam MA Abubeih, MD ortho study director
Assiut University , 71515 Assiut, Arab Republic of Egypt.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture Non Union, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael G. Waheeb, Msc ortho (+201224414404, michael_ortho_surg@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: from enrollment to one year follow up after the definitive stage.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04681846, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.