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NCT Number: NCT06923579

Treatment Of Meta-diaphyseal Bone Defect In Long Bone With Titanium Mesh Cage

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.

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Exclusion Criteria:
  • 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

Treatment and study plan

Titanium Mesh Cage

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence and rate of complications (e.g. non-union, post-operative infections.....)

    Time frame: 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aly Mohammaden Professor

CONTACT

[email protected]

00201222443531

Mohamed Adel Doctor

CONTACT

[email protected]

00201141095244

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Treatment Of Meta-diaphyseal Bone Defect In Long Bone With Titanium Mesh Cage : Case Series Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.