Do you cram standard pillows between your legs and still sleep poorly? A knee spacer is specially designed to fit between your legs and to support you throughout the night. It is ideal for those experiencing hip, leg, back, or joint pain that prevents them from sitting or sleeping. When sleeping on an hourglass mattress, your legs, hips, and spine are aligned in parallel.
The lower back, legs, hips, ankles, and joints are less likely to suffer from discomfort. The process increases circulation and decreases pressure by reducing the distance between the joints. The pillow has a strap for keeping it between the legs during sleep. The cover can be removed and washed.
Overview of Knee Spacer
Sky Medical Knee Spacers treat permanent prosthesis infections in a two-phase procedure. During 180 days or less, Sky Medical Knee Spacer implants are intended for temporary use only. Besides providing basic joint mobility, the implants release antibiotics to prevent bacteria from colonizing.
After removing the knee spacer, the Sky Medical Knee Joint Implant will be replaced with a permanent implant.
Essentially, Sky Medical Knee Spacers are two separate implants (femoral and tibial) that, when assembled, can better fit the patient's anatomy. Sky Medical offers a Tibial Insert Wedge Component that can be customized to the best possible fit for each patient.
Sky Medical Femoral Components (four sizes available) may be matched with Sky Medical Tibial Components (three sizes available). There are three sizes of Sky Medical Tibial Insert Wedge (available in several colors). Each wedge is only compatible with its corresponding Tibial Component.
Knee spacers from Sky Medical:
- Single-use medical devices/ethylene oxide sterilization
- It is made with bone cement (PMMA) and gentamicin
- Gentamicin must be released
Sky Medical Knee Spacer indications
Sky Medical Knee Spacers, including a Femoral/Tibial Component, Tibial Insert, and Tibial Spacer, are indicated for short-term (maximum 180 days) use as adjuncts to total knee replacements (TKR).
Due to the septic process, the procedure requires two stages, where gentamicin is the most suitable antibiotic based on the susceptibility pattern of the infected microbes. The existing implant must be removed to apply the Sky Medical Knee Spacer, and surgery to debride the tibial plate. There is no need to use the Tibial insert unless there is a large tibial defect.
A systemic antimicrobial, antibiotic therapy is intended to be used with the device (the standard treatment for an infection). Using the Sky Medical Knee Spacer for more than 180 days requires removal and replacement with a permanent device or appropriate therapy (e.g., resection hip or knee replacement, fusions).
This device can only be used by patients who consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period due to the mechanical limitations of the device materials (gentamicin/polymethyl methacrylate).
Contraindications associated with Sky Medical knee spacers
- Patients with vascular, nervous, or muscular deficiencies.
- The implant can fracture or migrate due to osteoporosis or poor bone quality.
- It is impossible to insert and fix the knee spacer because there is insufficient bone.
- An arthroplasty procedure is contraindicated in patients with a decreased immune response or systemic medical conditions.
- TKR devices infected with the virus cannot be removed.
- Patients with hypersensitivity (allergy) to PMMA, aminoglycosides, or gentamicin.
- A lack of adequate bone structure prevents the spacer from being adequately supported.
- Inadequate knowledge of peripheral ligamentous apparatus and extensor mechanisms (both anatomically and functionally).
- It cannot be confirmed whether the TKR is infected.
- Infection with bacteria/pathogens resistant to gentamicin.
- A bacterium/pathogen that is infected is not susceptible to gentamicin.
- There is a suspicion or verification of a remote infection (systemic/secondary).
- The disease Myasthenia gravis.
- There is no TKR, and the infections result from trauma, septic arthritis, or other surgical procedures.
- A neuromuscular disorder makes it impossible for the patient to control his knee joint.
- Inability or unwillingness to use a protective weight-bearing device during implanting (cane, walker, crutches, etc.).
- The surgeon might expect an early failure of the knee spacer based on the patient's age, weight, or activity level.
Possible Adverse events
The following is a list of frequent and serious side effects when using Sky Medical knee spacers. It should be noted that some possible outcomes of the device are not directly related to it; however, the surgeon needs to be prepared to deal with them.
Surgical risks (general): pulmonary embolism, myocardial infarction, arrhythmias, venous thrombosis, and transitory hypotension.
Surgery Risks (TKR): the variety of problems associated with differences in limb length, such as wound healing issues, bone damage, blood vessel damage, nerve damage, bone bed damage, excessive blood loss, phlebitis, thrombophlebitis, and hematomas.
Sky Medical Knee Spacer risks Infection recurrence, gentamicin toxicity (ototoxicity, nephrotoxicity), implant breakage, implant loosening, PMMA sensitivity, debris release, difficult removal of the implant, dislocation of the implant, and foreign body reaction.
Implantation/Utilization
The right size should be chosen according to the dimensions of the implant removed, the type of bone defect, and the flexion and extension spaces.
Furthermore, consideration should be given to the implant's stability and range of motion: full extension and 90 degrees of flexion are essential, preferably with a flexion area close enough to prevent anterior-posterior movement. It is possible to determine the correct measurement through the Sky Medical Knee Trial and the size of the removed tibial and femoral components.
Explanation
Sky Medical Knee Spacers are not intended as permanent prostheses and must be removed within 180 days of implantation. It is possible to use revision instruments during the surgical procedure (mallets, osteotomes, etc.).
The wound site should be thoroughly cleaned before implanting a definitive implant or performing an alternative surgical procedure (e.g., resection arthroplasty, fusion, etc.). A revision implant not removed from cement or bone debris may not last as long as it should.
How is it supplied?
Knee spacers provided by Sky Medical Supplies is packaged and sterile. They should not be re-sterilized. Please make sure all packages are intact before using them. In the case of an opened, contaminated, or damaged package, please do not use it.
For any further queries, please contact Sky Medical Supplies during working hours. During working hours, we are available at 8340 Northfield Blvd Unit 1680, Denver, CO 80238.