Epiphyseal Staple Specification, Uses, Sizes and Surgical Techniques.

Epiphyseal Staple

Epiphyseal Staple is used for correcting angular deformity at the knee. Two or more Epiphyseal Staple should be used on each side of the epiphysis.

Our Epiphyseal Staples are made from finest quality medical grade material to ensure highest quality. Different sizes of Epiphyseal Staples are:

  • Dia(A) x Length(B) x Length(C) = 1.5 mm x 16 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 1.5 mm x 22 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 1.5 mm x 26 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 2.0 mm x 16 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 2.0 mm x 22 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 2.0 mm x 26 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 2.5 mm x 16 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 2.5 mm x 22 mm x 19 mm
  • Dia(A) x Length(B) x Length(C) = 2.5 mm x 26 mm x 19 mm

Epiphyseal Staple for angular deformity at the knee

Fifty six patients with angular deformities of eighty-two knees were treated with Epiphyseal Staple between 1954 and 1973 and followed until maturity. There were sixty-four knock-knees and eighteen bowlegs. In twelve patients with concurrent leg-length discrepancies, long legs were stapled asymmetrically. The deformities were allowed to overcorrect before the Epiphyseal Staple were removed, but the rebound phenomenon occurred in twenty-two patients with thirty-five deformities. In older children the Epiphyseal Staple were taken out when the legs looked straight. Exaggerated physiological deformities may correct spontaneously. They should not be stapled before the skeletal age of eleven in girls and twelve in boys. Secondary deformities are corrected earlier. There were no significant complications. Ten revisions of Epiphyseal Staples were necessary because of extrusion or shifting. The results were satisfactory or improved in 87 per cent of the deformities. When it is indicated epiphyseal stapling is a safe and effective method of correcting angular deformity at the knee in growing children.

Control of bone growth by epiphyseal staple

  • Efficient stapling of the distal femoral and proximal tibial epiphyses stops the elongation of bone at these epiphyses immediately and almost completely.
  • The operation is less extensive and the risk of complication is less than with other operative methods of controlling bone growth.
  • Angular deformity may be corrected during the growth period. Knock-knee, bowleg, back-knee, flexion deformity, or combinations of these deformities are rapidly overcome.
  • The occasional complicating irregularities of growth following stapling should be detected clinically and corrected immediately by rearrangement of the staples.
  • After removal of the epiphyseal staples, growth at the epiphysis is resumed at about the same rate as would be expected on the other side, if both sides were normal. It is sometimes faster and sometimes slower. The variations in rate are usually caused by factors other than epiphyseal staples.
  • The best proof of the normal rate of growth after removal of epiphyseal staples are the persistence of a straight extremity after correction of an idiopathic knock-knee.

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Epiphyseal Staple 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 Epiphyseal Staple.

Warnings and Precautionary for Epiphyseal Staple

Before using Epiphyseal Staple, 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.

Epiphyseal Staple is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Epiphyseal Staple 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  Epiphyseal Staple 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 Epiphyseal Staple.

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 implant, 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 implant.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for Epiphyseal Staple

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 set of implants must be available.

The clinician should discuss with the patient the possible risks and complications associated with the use of Epiphyseal Staple. 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.

Epiphyseal Staple 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 screw.
  • 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.

Epiphyseal Staple Warnings

  • Epiphyseal Staple 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. Implant removal should be followed by adequate post-operative management to avoid refracture.

Epiphyseal Staple 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 implant, reoperation.