External fixation is a technique that uses external devices (such as metal brackets, connecting rods, and pins or screws percutaneously inserted into the bone) to stabilize fractures or correct deformities. Its main advantages are minimally invasive and adjustable features, making it suitable for complex trauma or cases with a high risk of infection.
The image above shows the names and application locations of various external fixators on different parts of the human skeletal system. An external fixator is a medical device primarily used in orthopedic surgery to stabilize fractured or treated bone areas via an external device, promoting healing or correction. These external fixators are designed based on different body parts and requirements, and are used in various orthopedic surgeries and treatment scenarios.
Introduction to external fixation
External fixation can be classified by structure into unilateral external fixation, circular external fixation, and hybrid external fixation.
Unilateral external fixation:
Characteristics: The fixation needle is inserted only from one side of the limb, and the scaffold is located on one side.
The unilateral external fixator is a medical device used for fixation and support after fractures or orthopedic surgery. Its design features and advantages are mainly reflected in the following aspects:
Design features
Simple structure: A unilateral external fixator usually consists of one or more fixation arms, adjustment screws, pins or nails, with a relatively simple structure that is easy to operate and install.
Lightweight: Compared with traditional bilateral external fixators, the single-sided design reduces the use of metal structures, making the overall weight lighter and providing more comfort for patients when wearing.
Adjustability: The fixed arm and screw design allow doctors to make fine adjustments based on the patient's specific conditions, adapting to different types of fractures and bone conditions.
Minimally invasive: Unilateral external fixators are usually fixed with a small number of bone pins or screws, reducing soft tissue damage and lowering the risk of infection.
Advantages
High comfort: Due to the lightweight structure and fewer fixation points, patients will feel more comfortable during wear, especially suitable for cases that require long-term fixation.
Greater range of motion: The unilateral design reduces restrictions on joint movement, allowing patients to perform more functional exercises during rehabilitation, which promotes recovery.
Low complication risk: Due to fewer fixation points and minimally invasive procedure, the incidence of complications such as infection and pin-track inflammation is relatively low.
Ideal for complex fractures: The unilateral external fixator is particularly suitable for handling some complex or open fractures, especially when it is necessary to minimize soft tissue damage.
Convenient for postoperative care: The single-sided design makes daily life and care more convenient for patients, such as cleaning and dressing changes.
Relevant scenarios
Unilateral external fixators are commonly used in the following scenarios:
Fractures of the limbs: especially fractures of long bones such as the humerus, ulna, radius, femur, and tibia.
Open fracture: Due to its minimally invasive nature, it is suitable for managing open fractures to reduce the risk of infection.
Non-union or delayed union: In some cases, a unilateral external fixation frame can assist in bone healing.
Postoperative fixation: Used for fixation and support after orthopedic surgery.
The design concept of the unilateral external fixator is patient-centered, focusing on comfort, functionality, and safety, making it an important tool in orthopedic treatment.
Circular external fixator:
Characteristics: Composed of metal rings and fine wires, encircling the limb and allowing multi-planar adjustments.
The circular external fixator is a medical device used for fracture fixation and orthopedic rehabilitation. Its design features and advantages are mainly reflected in the following aspects:
Design features
The ring structure: The circular external fixator is designed with a ring shape, forming a complete circle around the fracture site to provide comprehensive support and fixation.
Multiple fixation points: There are usually multiple fixation points on the circular frame, which can be connected to the bone through multiple bone pins or nails. This disperses the fixation force and reduces pressure on a single fixation point.
Adjustability: The design of the circular external fixator allows doctors to make adjustments according to the patient's specific conditions, including the size of the rings, the position of fixation points, and the distribution of force, to accommodate different types of fractures and bone conditions.
Lightweight and durable: Modern circular external fixators are often made of lightweight and high-strength materials such as titanium alloy or carbon fiber, ensuring stability while reducing the burden on the patient.
Easy to install and remove: The ring design makes the installation and removal process more convenient, reducing surgery time and patient discomfort.
Advantages
High stability: The ring structure provides all-round support, which can effectively prevent displacement of the fracture site and ensure that the bones remain in the correct position during the healing process.
Dispersive force: Multiple fixation points disperse the fixation force, reducing concentrated pressure on bones and soft tissues, and lowering the risk of complications caused by improper fixation.
Wide range of applications: The circular external fixator is suitable for various types of fractures, especially complex fractures, open fractures, and cases that require long-term fixation.
Promoting healing: By providing a stable fixation environment, the circular external fixator helps to accelerate fracture healing and reduce the risk of nonunion or delayed healing.
Reduce complications: Due to the dispersed fixation force, the circular external fixator reduces soft tissue damage and decreases the incidence of complications such as infection and pin tract inflammation.
Convenient for postoperative care: The annular design makes it more convenient for patients to take care of themselves after surgery, such as cleaning and changing dressings, without affecting the fixation effect.
Applicable scenarios
Circular external fixators are commonly used in the following situations:
Complex fractures: Suitable for complex fractures involving multiple bone segments or joints.
Open Fractures: Due to its force-dispersing characteristics, the circumferential external fixator is suitable for the management of open fractures and reduces the risk of infection.
Non-union or delayed union: In some cases, circular external fixation frames can aid in bone healing by providing the necessary stability and support.
Postoperative fixation: Used for stabilization and support after orthopedic surgery, ensuring the stability of the surgical site.
The design concept of the circular external fixator is also patient-centered, focusing on stability and comfort, and is an important tool in orthopedic treatment.
Hybrid external fixator:
Features: Combines a unilateral brace with a ring component for fractures of adjacent joints.
The hybrid external fixator combines the design features of unilateral and circular external fixators, making it a more flexible and adaptable external fixation device. Its design features and advantages are mainly reflected in the following aspects:
Design features
Assembled structure:
The hybrid external fixator is usually composed of components from both unilateral and circular fixators, providing a variety of fixation options for different types of fractures or bone conditions.
Modular design:
The components of the hybrid external fixator can be flexibly combined, allowing doctors to choose different fixation arms, circular frames, or connection methods based on the specific needs of the patient.
Multiple fixation points:
By combining a unilateral fixation arm with a circular frame, the hybrid external fixator can provide multiple fixation points, thereby enhancing the overall fixation effect.
Adjustability:
The hybrid design allows doctors to flexibly adjust the position, length of the fixation arms, and the size of the circular frame during the fixation process to accommodate the patient's bone structure and fracture characteristics.
Lightweight and Durability:
The use of high-strength, lightweight materials (such as titanium alloys or carbon fiber) ensures the stability of the device while reducing the burden on the patient.
Advantages
Higher stability:
The hybrid external fixator, by combining unilateral fixation arms with a circular frame, can provide more comprehensive support and fixation, reducing the risk of displacement at the fracture site.
Adaptable:
It is suitable for various complex types of fractures, especially cases involving multiple bone segments, joints, or soft tissue injuries, and can flexibly adjust the fixation method according to specific conditions.
Minimize soft tissue damage:
The hybrid design can reduce soft tissue interference through a unilateral fixation arm while providing better stability via the circular frame, thereby reducing the risk of complications.
Promoting fracture healing:
A stable fixation environment contributes to fracture healing, especially in complex cases requiring long-term fixation, effectively preventing nonunion or delayed healing.
Convenient for postoperative care:
The design of the hybrid external fixator makes it more convenient for patients to clean, care for, and change dressings after surgery, without affecting the fixation effect.
Personalized treatment:
The modular design allows doctors to choose the most suitable fixation method according to the specific fracture and bone characteristics of the patient, achieving personalized treatment.
Minimally invasive:
Hybrid external fixation frames typically use minimally invasive techniques, reducing surgical trauma and shortening recovery time.
Applicable scenarios
Hybrid external fixators are commonly used in the following complex orthopedic conditions:
Complex fractures of long bones: such as complex fractures of the femur, tibia, and humerus.
Nonunion or delayed healing: For cases with difficult bone healing, the hybrid external fixator can provide more stable support.
Intra-articular fractures: Applicable to fractures in the joint area, providing better protection for joint function.
Open fracture: minimize soft tissue damage and reduce the risk of infection.
Bone deformity correction: In orthopedic corrective surgery, hybrid external fixation frames can provide flexible support and adjustment.
Postoperative auxiliary fixation: Used for auxiliary fixation and rehabilitation after orthopedic surgery.
User feedback and market performance
External fixators, as an important orthopedic medical device, are widely used in clinical settings for fracture fixation, nonunion treatment, deformity correction, and postoperative rehabilitation. User feedback and market performance can be analyzed from multiple dimensions, including patient experience, physician perspective, and market acceptance. The following are some key points:
User feedback
Patient feedback
- Comfort:
• Patients generally find external fixators more comfortable than traditional plaster casts, especially single-sided and hybrid external fixators, which are lighter and impose fewer restrictions on joint movement.
• Patients have a higher acceptance of the appearance of external fixators. Compared with traditional metal brackets, the design of modern external fixators is more aesthetically pleasing, reducing the psychological burden on patients.
- Functionality:
• External fixators allow patients to perform a certain degree of functional exercise while being fixed, especially the unilateral and hybrid designs, which can better maintain joint range of motion and promote recovery.
• Patients highly appreciate the adjustability of external fixators, especially hybrid external fixators, which can gradually adjust the fixation strength according to the fracture healing situation, reducing postoperative discomfort.
- Complications:
• Some patients reported complications such as pin tract infection and pin tract inflammation, especially when the fixation time is long.
• Due to the higher number of fixation points, patients may experience a feeling of pressure or discomfort at the fixation sites, especially during the initial adaptation phase.
- Convenience of care:
• Patients give high evaluations to the postoperative care convenience of external fixation frames, especially unilateral and hybrid designs, which are easy to clean and change dressings.
• Some patients reported that the external fixator might be subject to external impact or friction during daily activities, affecting comfort.
Doctor feedback
- Ease of use:
• Doctors consider the installation and removal of external fixators relatively simple, especially for unilateral and hybrid external fixators, which can quickly complete surgical operations.
• The circular external fixator requires a higher level of technical skill and more precise preoperative planning, and doctors report needing more time for adjustments when using it in complex fracture cases.
- Fixation stability:
• Doctors highly evaluate the stability of external fixators, especially when dealing with complex fractures (such as comminuted fractures, open fractures), the supporting effect of circular external fixators is more significant.
• Unilateral external fixation frames may have slightly weaker fixation in some cases and need to be used in conjunction with other fixation methods (such as internal fixation).
- Adaptability:
• The doctor believes that external fixation frames have a high degree of adaptability, allowing for personalized adjustments based on the patient's fracture type, bone condition, and functional needs.
• The application of hybrid external fixators in complex cases is more flexible, as they can combine the advantages of unilateral and circular fixators, providing a more comprehensive fixation solution.
- Risk of complications:
• Doctors report a lower complication rate with external fixators, especially with unilateral and hybrid designs. However, since they penetrate the skin and bone, there is still a need to be cautious about the risk of pin-site infections and soft tissue injuries.
- Postoperative rehabilitation effect:
• Doctors believe that external fixators can significantly promote fracture healing, especially in cases requiring long-term fixation, as they can provide a stable mechanical environment.
• The effectiveness of circular external fixators is more prominent in cases of non-union or delayed healing, but patients may need a longer adaptation period.
Market performance
Market demand
- Growing demand for fracture fixation:
• With the increasing incidence of traffic accidents, sports injuries, etc., the demand for fracture fixation is growing year by year. As an important orthopedic medical device, the market demand for external fixators continues to grow.
- Increasing demand for complex cases:
• The application of circular external fixation frames and hybrid external fixation frames in complex fractures, nonunion, and correction of bone deformities is becoming increasingly widespread, with market demand gradually shifting towards high-end products.
Market competition
Technology innovation drives the market:
• With advancements in materials science and manufacturing technology, external fixation frames have become more lightweight, modular, and intelligent, attracting more doctors and patients to choose them.
• The hybrid external fixator has become a popular product in the market due to its flexibility and adaptability.
Regional market performance
- European and American markets:
• Circular and hybrid external fixators perform well in the European and American markets due to their mature technology and suitability for complex fractures.
- Asian market:
• Unilateral external fixators are more popular in the Asian market, especially in areas with a higher number of fracture cases (such as China and India), due to their lower cost and ease of use.
• With the improvement of medical technology, the acceptance of circular and hybrid external fixators in the Asian market is gradually increasing.
Future development trends
- Intelligence and Digitalization:
• External fixators with smart monitoring functions are gradually appearing on the market, which can real-time monitor the fracture healing and mechanical status of the fixator, further improving the treatment effect.
- Minimally invasive design:
• The minimally invasive design of external fixators is gaining more attention, reducing the risk of surgical trauma and postoperative complications.
- Personalized customization:
• Personalized external fixators based on 3D printing technology are gradually entering the market, capable of being customized according to the patient's specific bone structure, enhancing fixation effectiveness and comfort.
The external fixator has gained widespread clinical recognition, with both patients and doctors giving high praise for its comfort, functionality, and stability. The unilateral external fixator is suitable for simple fracture fixation, the circular external fixator is appropriate for complex fractures and non-unions, while the hybrid external fixator has become a significant product in the high-end market due to its flexibility and adaptability.
The demand for external fixators in the market continues to grow, and a competitive landscape between international and domestic brands is gradually forming. Technological innovations are driving further market development. In the future, with technological advancements and diversification of medical needs, the market prospects for external fixators will become even broader.
Procurement Guidelines
As a type of orthopedic medical device, the procurement of external fixators needs to take into account multiple factors such as clinical requirements, product performance, price cost, and brand as well as technical support. The following is a detailed purchasing guide for external fixators to help make an informed choice:
External Fixator Procurement Guidelines
1. Identify clinical needs
Types of fractures:
Identify the type of patient's fracture (such as simple fracture, complex fracture, nonunion, bone deformity, etc.), and select the appropriate type of external fixator (unilateral, circular, or hybrid).
Fixation site:
Select appropriate design and size based on the fracture location (such as upper limb, lower limb, spine, etc.).
Patient population:
Consider the patient's age, activity level, and bone condition when selecting the appropriate fixation strength and design.
Surgical requirement:
For complex fractures or non-unions, it may be necessary to choose circular or hybrid external fixators; for simple fractures, a unilateral external fixator may be more appropriate.
2. Evaluate product performance
Fixation stability:
Select an external fixator that can provide sufficient stability, especially for patients with complex fractures or non-unions.
Adjustability:
Hybrid external fixators typically offer better adjustability, allowing for gradual adjustment of fixation strength based on the fracture healing condition.
Comfort:
Choose lightweight and aesthetically designed products to reduce the psychological burden on patients and the discomfort during daily activities.
Complication risks:
Selecting an external fixator with excellent materials and rational design can reduce the risk of complications such as pin-track infection and soft tissue damage.
3. Selection of materials and design
Materials:
High-quality titanium alloy or stainless steel materials are common choices for external fixators, offering good biocompatibility and durability.
Some high-end products use lightweight composite materials to further enhance patient comfort.
Design:
The circular external fixator usually has higher fixation strength and stability, but may require more complex preoperative planning.
The unilateral external fixator is easy to operate and suitable for simple fracture fixation, but the fixation effect may be slightly weaker.
The hybrid external fixator combines the advantages of unilateral and circular fixators, making it suitable for complex cases.
4. Compare prices and cost-effectiveness
Price difference:
The unilateral external fixator is less expensive and suitable for simple fracture fixation.
The prices of circular and hybrid external fixators are higher, but their performance is better and they are suitable for complex cases.
Cost-effectiveness:
Considering the long-term usage effect and patients' recovery, choose products with high cost performance.
Some high-end products, although with higher initial costs, can reduce postoperative complications and shorten recovery time, offering better long-term cost-effectiveness.
5. Check product compliance
Certification and Standards:
Ensure that the external fixator complies with the medical device standards of the country or region (such as ISO).
Check if the product has relevant clinical trial data to support its safety and effectiveness.
After-sales service:
Choose a brand that offers comprehensive after-sales service, including product repair, technical support, and complication management, etc.
6. Choose the right supplier
Supplier qualifications:
Choose suppliers with legitimate qualifications to ensure the reliability of product sources.
Supply chain stability:
Select suppliers that can provide a stable supply chain to avoid surgery scheduling disruptions due to stock shortages.
Summary
The procurement of external fixators needs to comprehensively consider multiple factors such as clinical requirements, product performance, price cost, brand, and technical support. It is recommended to choose the most suitable product and supplier before procurement.
