Meta-diaphyseal Bone Defect In Long BoneNCT06923579
Treatment Of Meta-diaphyseal Bone Defect In Long Bone With Titanium Mesh Cage
An observational study of Meta-diaphyseal Bone Defect In Long Bone, run by Assiut University.
Trial summary
Meta-diaphyseal bone defects in long bones pose a significant challenge in orthopedic surgery. Traditional treatment methods include autologous bone grafts, allografts, and distraction osteogenesis. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Meta-diaphyseal Bone Defect In Long Bone
- What is being tested?
- Titanium Mesh Cage
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 25 Mar 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients at Assiut university hospitals, Department of Orthopaedics and Traumatology
Who may be able to join
- Age: Patients aged 16-60 years (adults of any gender)
- Defect Location: Meta-diaphyseal defects in long bones (femur, tibia, humerus)
- Defect Size: Critical-sized defects ≥2 cm in length
- Case Type: Both acute (traumatic/post-traumatic) and chronic (osteomyelitis, non-union) presentations
Who cannot join
- Soft Tissue Status: Inadequate soft tissue coverage requiring complex reconstruction (unreconstructable defects)
- Infection: Active local or systemic infection (e.g., unresolved osteomyelitis, sepsis)
- Host Status: Severe immunocompromise or systemic conditions contraindicating surgery (e.g., uncontrolled diabetes, renal failure)
- Prior Interventions: Previous failed reconstruction attempts with persistent instability
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Treatment Of Meta-diaphyseal Bone Defect In Long Bone With Titanium Mesh Cage : Case Series Study
Meta-diaphyseal bone defects in long bones pose a significant challenge in orthopedic surgery. Traditional treatment methods include autologous bone grafts, allografts, and distraction osteogenesis. Autologous bone grafting is often considered the gold standard due to its superior biological compatibility, but it is limited by complications such as donor site morbidity and the finite quantity of available graft material. Allografts provide an alternative but are associated with risks of immune rejection and disease transmission. Distraction osteogenesis, popularized by Ilizarov, allows for gradual bone regeneration and lengthening but requires prolonged treatment periods and carries the risk of complications like pin tract infections.
In the late 1990s, titanium mesh cages, particularly the Harms cage, emerged as a novel solution for meta-diaphyseal bone defects. Originally developed for spinal surgery, these cages were adapted for long bone reconstruction due to their structural stability and biocompatibility. The cylindrical design of titanium mesh cages provides mechanical support while allowing for the containment of bone graft material and promoting vascular ingrowth. This technique enables effective reconstruction of segmental defects by combining the cage with cancellous bone grafts or other substitutes.
Recent studies have demonstrated promising outcomes with titanium mesh cages in treating meta-diaphyseal defects. High union rates and favorable functional results have been reported in long-term follow-ups. The method offers advantages such as immediate structural stability and adaptability to various clinical scenarios, making it a valuable option for addressing complex bone defects. However, like all techniques, it is not without limitations, including potential complications such as residual limb length discrepancies or recurrent infections in some cases. Nonetheless, titanium mesh cages represent a significant advancement in the management of challenging long bone defects.
Read the detailed description
Meta-diaphyseal bone defects in long bones present a significant challenge in orthopedic surgery. Traditional treatment methods include autologous bone grafts, allografts, and distraction osteogenesis. Autologous bone grafting, considered the gold standard, is limited by donor site morbidity and the finite availability of graft material. Allografts provide an alternative but carry risks such as immune rejection and disease transmission. Distraction osteogenesis, popularized by Ilizarov, allows for gradual bone lengthening but requires prolonged treatment periods and may lead to complications like pin tract infections. More recently, bioengineered materials and growth factors have been explored as potential solutions, but their clinical application remains challenging.
Open fractures are classified based on orthogonal radiographs to assess the extent and geometry of bone loss. These classifications include incomplete defects (D1), minor or subcritical complete defects (D2), and segmental or critical-sized defects (D3). Incomplete defects (D1) are further divided into D1A (<25% cortical loss), D1B (25-75% cortical loss), and D1C (>75% cortical loss). Minor/subcritical defects (D2) are categorized as D2A (two oblique ends allowing overlap), D2B (one oblique end and one transverse end), and D2C (two transverse ends). Segmental/critical-sized defects (D3) are classified into D3A (moderate defects, 2 to <4 cm), D3B (major defects, 4 to <8 cm), and D3C (massive defects, ≥8 cm). The reliability of these classifications has been assessed using Fleiss' kappa tests among independent observers.
The use of titanium mesh cages, particularly the Harms cage, emerged in the late 1990s as a novel approach for treating meta-diaphyseal bone defects. Initially developed for spinal surgery, the Harms cage was adapted for long bone reconstruction due to its structural stability and biocompatibility. These cages provide immediate mechanical support while promoting bone ingrowth, addressing many limitations of traditional methods. The porous structure facilitates vascularization and integration with surrounding bone, potentially leading to improved healing outcomes.
Titanium mesh cages offer several advantages in managing meta-diaphyseal defects. They maintain bone length, provide immediate stability, and allow for earlier weight-bearing. However, challenges such as the risk of subsidence and the need for precise surgical technique remain. Recent studies have reported high union rates and favorable functional outcomes in long-term follow-ups, suggesting that titanium mesh cages are a reliable option for treating complex long bone defects.
This case series study aims to evaluate the efficacy of titanium mesh cages in addressing meta-diaphyseal bone defects. It focuses on clinical outcomes, radiographic healing, and patient-reported functional improvements. By validating this technique, titanium mesh cages could potentially set a new standard in managing challenging bone defects in orthopedic surgery.
- Conditions
- Meta-diaphyseal Bone Defect In Long Bone
- Being tested
- Titanium Mesh Cage
- Keywords
- Meta-diaphyseal Bone Defect In Long Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium Mesh CageProcedure or surgery
the Harms cage was adapted for long bone reconstruction due to its structural stability and biocompatibility. The cage provides immediate mechanical support while allowing for bone ingrowth, addressing the limitations of traditional methods.
Advantages of the titanium mesh cage include its ability to maintain bone length, provide immediate stability, and allow for earlier weight-bearing. The porous structure facilitates vascularization and bone integration, potentially leading to improved healing outcomes
| Study group | Role | What they receive |
|---|---|---|
| Adult patients 16 - 60 years old in both gender | Not described Receives: Procedure: Titanium Mesh Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bone Union Assessment in Critical-Sized Defects
This primary outcome measure evaluates bone union in critical-sized defects using standardized anteroposterior and lateral X-ray assessments. Union is defined by three key radiographic criteria:
Bridging trabeculae, Callus maturation and Fracture line resolution
Measured: 1 month
Secondary outcomes (1)
Incidence and rate of complications (e.g. non-union, post-operative infections.....)
This measure evaluates complication rates following titanium mesh cage (TMC) reconstruction for meta-diaphyseal defects. Complications are categorized as:
Non-union Postoperative infections Hardware-related issues Limb dysfunction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion25 Mar 2028 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Meta-diaphyseal Bone Defect In Long BoneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel Ragab Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923579
- Sponsor's protocol ID
- Meta-diaphyseal Bone Defect
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feltri P, Solaro L, Di Martino A, Candrian C, Errani C, Filardo G. Union, complication, reintervention and failure rates of surgical techniques for large diaphyseal defects: a systematic review and meta-analysis. Sci Rep. 2022 Jun 1;12(1):9098. doi: 10.1038/s41598-022-12140-5.
PubMed 35650218Attias N, Thabet AM, Prabhakar G, Dollahite JA, Gehlert RJ, DeCoster TA. Management of extra-articular segmental defects in long bone using a titanium mesh cage as an adjunct to other methods of fixation: a multicentre report of 17 cases. Bone Joint J. 2018 May 1;100-B(5):646-651. doi: 10.1302/0301-620X.100B5.BJJ-2017-0817.R2.
PubMed 29701099Klezl Z, Bagley CA, Bookland MJ, Wolinsky JP, Rezek Z, Gokaslan ZL. Harms titanium mesh cage fracture. Eur Spine J. 2007 Dec;16 Suppl 3(Suppl 3):306-10. doi: 10.1007/s00586-007-0377-z. Epub 2007 May 12.
PubMed 17497187Cobos JA, Lindsey RW, Gugala Z. The cylindrical titanium mesh cage for treatment of a long bone segmental defect: description of a new technique and report of two cases. J Orthop Trauma. 2000 Jan;14(1):54-9. doi: 10.1097/00005131-200001000-00011.
PubMed 10630804Solomon LB, Callary SA, Boopalan PR, Chakrabarty A, Costi JJ, Howie DW. Impaction bone grafting of segmental bone defects in femoral non-unions. Acta Orthop Belg. 2013 Feb;79(1):64-70.
PubMed 23547518Einhorn TA, Gerstenfeld LC. Fracture healing: mechanisms and interventions. Nat Rev Rheumatol. 2015 Jan;11(1):45-54. doi: 10.1038/nrrheum.2014.164. Epub 2014 Sep 30.
PubMed 25266456Rosslenbroich SB, Oh CW, Kern T, Mukhopadhaya J, Raschke MJ, Kneser U, Krettek C. Current Management of Diaphyseal Long Bone Defects-A Multidisciplinary and International Perspective. J Clin Med. 2023 Sep 29;12(19):6283. doi: 10.3390/jcm12196283.
PubMed 37834927Tetsworth KD, Burnand HG, Hohmann E, Glatt V. Classification of Bone Defects: An Extension of the Orthopaedic Trauma Association Open Fracture Classification. J Orthop Trauma. 2021 Feb 1;35(2):71-76. doi: 10.1097/BOT.0000000000001896.
PubMed 32639397
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Meta-diaphyseal Bone Defect In Long Bone With Titanium Mesh Cage : Case Series Study
- ClinicalTrials.gov ID
- NCT06923579
- Acronym / sponsor ID
- Meta-diaphyseal Bone Defect
- Conditions
- Meta-diaphyseal Bone Defect In Long Bone
- Keywords
- Meta-diaphyseal Bone Defect In Long Bone
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 25 Mar 2028 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 11 Apr 2025 (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.
Meta-diaphyseal bone defects in long bones pose a significant challenge in orthopedic surgery. Traditional treatment methods include autologous bone grafts, allografts, and distraction osteogenesis. Autologous bone grafting is often considered the gold standard due to its superior biological compatibility, but it is limited by complications such as donor site morbidity and the finite quantity of available graft material. Allografts provide an alternative but are associated with risks of immune rejection and disease transmission. Distraction osteogenesis, popularized by Ilizarov, allows for gradual bone regeneration and lengthening but requires prolonged treatment periods and carries the risk of complications like pin tract infections.
In the late 1990s, titanium mesh cages, particularly the Harms cage, emerged as a novel solution for meta-diaphyseal bone defects. Originally developed for spinal surgery, these cages were adapted for long bone reconstruction due to their structural stability and biocompatibility. The cylindrical design of titanium mesh cages provides mechanical support while allowing for the containment of bone graft material and promoting vascular ingrowth. This technique enables effective reconstruction of segmental defects by combining the cage with cancellous bone grafts or other substitutes.
Recent studies have demonstrated promising outcomes with titanium mesh cages in treating meta-diaphyseal defects. High union rates and favorable functional results have been reported in long-term follow-ups. The method offers advantages such as immediate structural stability and adaptability to various clinical scenarios, making it a valuable option for addressing complex bone defects. However, like all techniques, it is not without limitations, including potential complications such as residual limb length discrepancies or recurrent infections in some cases. Nonetheless, titanium mesh cages represent a significant advancement in the management of challenging long bone defects.
Detailed description
Meta-diaphyseal bone defects in long bones present a significant challenge in orthopedic surgery. Traditional treatment methods include autologous bone grafts, allografts, and distraction osteogenesis. Autologous bone grafting, considered the gold standard, is limited by donor site morbidity and the finite availability of graft material. Allografts provide an alternative but carry risks such as immune rejection and disease transmission. Distraction osteogenesis, popularized by Ilizarov, allows for gradual bone lengthening but requires prolonged treatment periods and may lead to complications like pin tract infections. More recently, bioengineered materials and growth factors have been explored as potential solutions, but their clinical application remains challenging.
Open fractures are classified based on orthogonal radiographs to assess the extent and geometry of bone loss. These classifications include incomplete defects (D1), minor or subcritical complete defects (D2), and segmental or critical-sized defects (D3). Incomplete defects (D1) are further divided into D1A (<25% cortical loss), D1B (25-75% cortical loss), and D1C (>75% cortical loss). Minor/subcritical defects (D2) are categorized as D2A (two oblique ends allowing overlap), D2B (one oblique end and one transverse end), and D2C (two transverse ends). Segmental/critical-sized defects (D3) are classified into D3A (moderate defects, 2 to <4 cm), D3B (major defects, 4 to <8 cm), and D3C (massive defects, ≥8 cm). The reliability of these classifications has been assessed using Fleiss' kappa tests among independent observers.
The use of titanium mesh cages, particularly the Harms cage, emerged in the late 1990s as a novel approach for treating meta-diaphyseal bone defects. Initially developed for spinal surgery, the Harms cage was adapted for long bone reconstruction due to its structural stability and biocompatibility. These cages provide immediate mechanical support while promoting bone ingrowth, addressing many limitations of traditional methods. The porous structure facilitates vascularization and integration with surrounding bone, potentially leading to improved healing outcomes.
Titanium mesh cages offer several advantages in managing meta-diaphyseal defects. They maintain bone length, provide immediate stability, and allow for earlier weight-bearing. However, challenges such as the risk of subsidence and the need for precise surgical technique remain. Recent studies have reported high union rates and favorable functional outcomes in long-term follow-ups, suggesting that titanium mesh cages are a reliable option for treating complex long bone defects.
This case series study aims to evaluate the efficacy of titanium mesh cages in addressing meta-diaphyseal bone defects. It focuses on clinical outcomes, radiographic healing, and patient-reported functional improvements. By validating this technique, titanium mesh cages could potentially set a new standard in managing challenging bone defects in orthopedic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients 16 - 60 years old in both gender | – | Procedure: Titanium Mesh Cage |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients at Assiut university hospitals, Department of Orthopaedics and Traumatology
Key inclusion criteria (4 listed)
- Age: Patients aged 16-60 years (adults of any gender)
- Defect Location: Meta-diaphyseal defects in long bones (femur, tibia, humerus)
- Defect Size: Critical-sized defects ≥2 cm in length
- Case Type: Both acute (traumatic/post-traumatic) and chronic (osteomyelitis, non-union) presentations
Key exclusion criteria (4 listed)
- Soft Tissue Status: Inadequate soft tissue coverage requiring complex reconstruction (unreconstructable defects)
- Infection: Active local or systemic infection (e.g., unresolved osteomyelitis, sepsis)
- Host Status: Severe immunocompromise or systemic conditions contraindicating surgery (e.g., uncontrolled diabetes, renal failure)
- Prior Interventions: Previous failed reconstruction attempts with persistent instability
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 |
|---|---|---|
| Titanium Mesh Cagethe Harms cage was adapted for long bone reconstruction due to its structural stability and biocompatibility. The cage provides immediate mechanical support while allowing for bone ingrowth, addressing the limitations of traditional methods. Advantages of the titanium mesh cage include its ability to maintain bone length, provide immediate stability, and allow for earlier weight-bearing. The porous structure facilitates vascularization and bone integration, potentially leading to improved healing outcomes | Procedure or surgery | Adult patients 16 - 60 years old in both gender |
Primary outcome
Radiographic Bone Union Assessment in Critical-Sized Defects
Time frame: 1 month
This primary outcome measure evaluates bone union in critical-sized defects using standardized anteroposterior and lateral X-ray assessments. Union is defined by three key radiographic criteria: Bridging trabeculae, Callus maturation and Fracture line resolution
1 secondary outcome
Incidence and rate of complications (e.g. non-union, post-operative infections.....)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 35650218Feltri P, Solaro L, Di Martino A, Candrian C, Errani C, Filardo G. Union, complication, reintervention and failure rates of surgical techniques for large diaphyseal defects: a systematic review and meta-analysis. Sci Rep. 2022 Jun 1;12(1):9098. doi: 10.1038/s41598-022-12140-5.
- Background: PubMed 29701099Attias N, Thabet AM, Prabhakar G, Dollahite JA, Gehlert RJ, DeCoster TA. Management of extra-articular segmental defects in long bone using a titanium mesh cage as an adjunct to other methods of fixation: a multicentre report of 17 cases. Bone Joint J. 2018 May 1;100-B(5):646-651. doi: 10.1302/0301-620X.100B5.BJJ-2017-0817.R2.
- Background: PubMed 17497187Klezl Z, Bagley CA, Bookland MJ, Wolinsky JP, Rezek Z, Gokaslan ZL. Harms titanium mesh cage fracture. Eur Spine J. 2007 Dec;16 Suppl 3(Suppl 3):306-10. doi: 10.1007/s00586-007-0377-z. Epub 2007 May 12.
- Background: PubMed 10630804Cobos JA, Lindsey RW, Gugala Z. The cylindrical titanium mesh cage for treatment of a long bone segmental defect: description of a new technique and report of two cases. J Orthop Trauma. 2000 Jan;14(1):54-9. doi: 10.1097/00005131-200001000-00011.
- Background: PubMed 23547518Solomon LB, Callary SA, Boopalan PR, Chakrabarty A, Costi JJ, Howie DW. Impaction bone grafting of segmental bone defects in femoral non-unions. Acta Orthop Belg. 2013 Feb;79(1):64-70.
- Background: PubMed 25266456Einhorn TA, Gerstenfeld LC. Fracture healing: mechanisms and interventions. Nat Rev Rheumatol. 2015 Jan;11(1):45-54. doi: 10.1038/nrrheum.2014.164. Epub 2014 Sep 30.
- Background: PubMed 37834927Rosslenbroich SB, Oh CW, Kern T, Mukhopadhaya J, Raschke MJ, Kneser U, Krettek C. Current Management of Diaphyseal Long Bone Defects-A Multidisciplinary and International Perspective. J Clin Med. 2023 Sep 29;12(19):6283. doi: 10.3390/jcm12196283.
- Background: PubMed 32639397Tetsworth KD, Burnand HG, Hohmann E, Glatt V. Classification of Bone Defects: An Extension of the Orthopaedic Trauma Association Open Fracture Classification. J Orthop Trauma. 2021 Feb 1;35(2):71-76. doi: 10.1097/BOT.0000000000001896.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Meta-diaphyseal Bone Defect In Long Bone, 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Adel Doctor (00201141095244, Mohamed.15235433@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Bone Union Assessment in Critical-Sized Defects (time frame: 1 month). 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 NCT06923579, which also lists 8 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 11 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.