Crosslink Connector Introduction, Sizes, Uses and Advantages.

Crosslink Connector

Crosslink Connector Introduction

Spinal disorders that necessitate fusion surgery frequently necessitate the requirement for stability and support in order to facilitate successful fusion and restore spinal function. Crosslink connector is critical in these situations. It support the spine throughout the fusion process, assisting in the healing and integration of the damaged spinal segments. It is typically used in conjunction with spinal instrumentation, such as pedicle screws and rods, to enhance the fusion process and prevent excessive movement between spinal segments.

Crosslink Connector Sizes

Crosslink Connectors are intended to connect and stabilise spinal rods or other spinal equipment, hence restricting motion at the fusion site. Crosslink connectors help transfer loads and stresses by linking nearby equipment, aiding the fusion process and reducing excessive movement that may inhibit proper fusion.

Crosslink connectors are available in a variety of sizes and configurations to meet a variety of surgical techniques and patient anatomy. They are usually built of biocompatible materials like titanium alloy, which give strength, longevity, and compatibility with the human body.

Our type 1 Crosslink Connector has four different length:
35mm to 42mm
42mm to 52mm
52mm to 62mm

Our Type 2 Crosslink Connector have lengths variying from 80mm to 200mm

Crosslink Connector Uses

A crosslink connector’s major uses is to limit the range of motion between the spinal segments, minimising stress on the fusion site. This limitation of mobility promotes bone growth and keeps the graft material from being disrupted, resulting in the formation of a solid fusion mass. A crosslink connector improves stability, which helps to reduce problems including pseudarthrosis (failed fusion) and instrumentation failure.

Crosslink Connector Advantage

Enhanced Stability: Crosslink connectors add another point of contact between spinal rods or other apparatus, boosting the overall stability of the structure. This stability reduces micro-motion at the fusion site, generating an environment favourable to bone development and fusion.

Improved Load Distribution: Crosslink connectors assist distribute loads and stresses uniformly across the fusion area by connecting nearby equipment. This balanced load distribution decreases stress on individual screws, rods, and bone grafts, lowering the likelihood of implant failure and facilitating faster fusion.

Reduced Pseudarthrosis Risk: The failure of bone fusion is referred to as pseudodarthrosis. By stabilising the fusion site and limiting excessive motion that could impair the healing process, crosslink connectors reduce the risk of pseudarthrosis. Crosslinks improve stability, which stimulates the formation of new bone tissue and facilitates effective fusion.

Surgeon Flexibility: Crosslink connectors provide surgeons with flexibility by allowing for customisation based on patient anatomy and surgical needs. They are available in a variety of sizes, forms, and configurations, allowing the surgeon to choose the best crosslink connection for each patient’s specific needs.

Crosslink Connector techniques

The purpose of spinal fusion surgery is to encourage the fusing of neighbouring vertebrae, resulting in a solid bone mass that immobilises the damaged spinal region. This fusion process is based on the formation of new bone tissue between the vertebrae, which eventually merges them together. It is critical to minimise mobility at the surgery site in order for the bone to develop and integrate properly.

In spinal fusion operations, stability is critical. When two or more vertebrae are fused, it is critical to keep the surgical site as motion-free as possible to allow for optimal bone growth and union. Excessive movement can disturb the fusion process, resulting in problems including pseudarthrosis or instrumentation failure. Crosslink connectors address this issue by increasing stability, decreasing stress at the fusion site, and promoting the creation of a solid fusion mass.

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Crosslink Connector Contraindications

Contraindications may be qualified or total, and need to be taken into consideration when evaluating the prognosis in each case. The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

Any active or suspected latent infection or marked local inflammation in or about the affected area.
Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.
Material sensitivity, documented or suspected.
Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to
failure of the device itself.
Patients having inadequate tissue coverage over the operative site.
Implant utilization that would interfere with anatomical structures or physiological performance.
Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
Other medical or surgical conditions which would preclude the potential benefit of surgery.
All associated diseases which could endanger the function and success of the Crosslink Connector.

Warnings and Precautionary for Crosslink Connector

Before using Crosslink Connector, the surgeon and ancillary staff should study the safety information in these instructions, as well as any product-specific information in the product description, surgical procedures and/or brochures.

Connector is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Connector assure best working results provided they are used in the proper manner. Therefore, the following instructions for use and safety recommendations must be observed.

Improper use of Crosslink Connector can lead to damage to the tissue, premature wear, destruction of the instruments and injury to the operator, patients or other persons.

It is vital for the operating surgeon to take an active role in the medical management of their patients. The surgeon should thoroughly understand all aspects of the surgical procedure and instruments including their limitations. Care in appropriate selection and proper use of surgical instruments is the responsibility of the surgeon and the surgical team. Adequate surgical training should be completed before use of implants.

Factors which could impair the success of the operation:

Allergies to implanted materials.
Localized bone tumours.
Osteoporosis or osteomalacia.
System disease and metabolic disturbances.
Alcohol and drug abuse.
Physical activities involving excessive shocks, whereby the implant is exposed to blows and/or excessive loading.
Patients who are mentally unable to understand and comply with the doctor’s instructions.
Poor general health.

Possible Adverse Effects

The following adverse effects are the most common resulting from implantation:

Loosening of the Connector, which may result from cyclic loading of the fixation site and/or tissue reaction of the implant.
Early and late infection.
Further bone fracture resulting from unusual stress or weakened bone substance.
Temporary or chronic neural damage resulting from pressure or hematomata.
Wound hematomas and delayed wound healing.
Vascular disease including venal thrombosis, pulmonary embolism and cardiac arrest.
Heterotopic ossification.
Pain and discomfort due to presence of the Crosslink Connector.
Mechanical failure of the implant, including bending, loosening or breakage.
Migration of implant resulting in injury.

Preoperative Planning for Crosslink Connector

The operating planning is carried out following a thorough clinical evaluation of the patient, Also, x-rays must be taken to allow a clear indication of the bony anatomy and associated deformities. At the time of the operation, the corresponding implantation instruments in addition to a complete size of Crosslink Connector must be available.

The clinician should discuss with the patient the possible risks and complications associated with the use of implants. It is important to determine pre-operatively whether the patient is allergic to any of the implant materials. Also, the patient needs to be informed that the performance of the device cannot be guaranteed as complications can affect the life expectancy of the device.

Crosslink Connector Precautions

Confirm functionality of instruments and check for wear during reprocessing. Replace worn or damaged instruments prior to use.
It is recommended to use the instruments identified for this Connector.
Handle devices with care and dispose worn bone cutting instruments in a sharps container.
Always irrigate and apply suction for removal of debris potentially generated during implantation or removal.

Crosslink Connector Warnings

Crosslink Connector can break during use (when subjected to excessive forces). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail.
Instruments, screws and cut plates may have sharp edges or moving joints that may pinch or tear user’s glove or skin.
Take care to remove all fragments that are not fixated during the surgery.
While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Connector removal should be followed by adequate post-operative management to avoid refracture.

Crosslink Connector General Adverse Events

As with all major surgical procedures, risks, side effects and adverse events can occur. While many possible reactions may occur, some of the most common include: Problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues incl. swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hypersensitivity reactions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the Crosslink Connector, reoperation.

Crosslink connectors providing increased stability to the cervical spine rod-screw construct

Object: The object of this study was to determine if the addition of transverse connectors (TCs) to a rod-screw construct leads to increased stabilization of the cervical spine.

Methods: Eleven human cadaveric cervical spines (C2-T1) were used to examine the effect of adding connectors to a C3-7 rod-screw construct in 3 models of instability: 1) C3-6 wide laminectomy, 2) wide laminectomy and 50% foraminotomy at C4-5 and C5-6, and 3) wide laminectomy with full medial to lateral foraminotomy. Following each destabilization procedure, specimens were tested with no TC, 1 TC between the C-5 screws, and 2 TCs between the C-4 and C-6 screws. Testing of the connectors was conducted in random order. Specimens were subjected to ± 2 Nm of torque in flexion and extension, lateral bending, and axial rotation. Range of motion was determined for each experimental condition. Statistical comparisons were made between the destabilized and intact conditions, and between the addition of TCs and the absence of TCs.

Results: The progressive destabilization procedures significantly increased motion. The addition of TCs did not significantly change motion in flexion and extension. Lateral bending was significantly decreased with 2 connectors, but not with 1 connector. The greatest effect was on axial rotation. In general, 2 TCs were more restrictive than 1 TC, and decreased motion 10% more than fixation alone.

Conclusions: Regardless of the degree of cervical destabilization, 1 or 2 TCs decreased motion compared with rods and screws alone. Axial rotation was most affected. Transverse connectors effectively increase the rigidity of rod-screw constructs in the cervical spine. Severe cervical instability can be overcome with the use of 2 TCs, but in cases in which 2 cannot be used, 1 should be adequate and superior to none.

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Crosslink Connector Introduction, Sizes, Uses and Advantages.