STERIS ARCH Orthopedic Leg Positioner™

Product Overview

The STERIS ARCH Orthopedic Leg Positioner provides controlled and repeatable leg movement. The Femoral elevation is achieved automatically by the counter lever effect of the table's edge when the leg is dropped during femoral preparation. ARCH is a surgical positioning device that allows you to place your patient into an orthopedic position for Anterior Approach to Total Hip Arthroplasty (AATHA), hip pinning, femur plating, and intramedullary (IM) femoral nailing surgical procedures.

How STERIS ARCH Orthopedic Leg Positioner works

The STERIS Orthopedic Leg Positioner provides leg support during operating procedures. ARCH streamlines procedures, supports repeatability, and frees the hands of the surgical team. It is fixed on a mobile base with large casters, making mobility effortless and granting the flexibility to pair with any general surgical table.

Why STERIS ARCH Orthopedic Leg Positioner?

A dedicated orthopedic table is typically expensive and bulky and tends to be challenging to move about the operating room (OR) and even into storage. The ARCH offers meticulous surgical positioning capabilities such as independent traction, rotation, extension, and ab/adduction controls, with a smaller footprint, making storage simple.

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Surgical Functions

The ARCH Orthopedic Leg Positioner has four measurable surgical functions: traction, rotation, extension/flexion, and adduction/abduction. Operators typically stand on the operative side for the simplest operation of these functions.

Traction

ARCH Orthopedic Leg Positioner provides traction from -40 mm to 100 mm in length as a leg traction device. To apply or remove traction, rotate the ARCH’s traction handwheel.

Rotation

The STERIS ARCH provides 360° of internal or external rotation of the patient’s leg. Rotation is typically controlled in increments of 10-degrees. A free-rotation setting is also available for convenience.

Extension/Flexion

The ARCH can have 41° of leg extension and 20° of leg flexion. A sliding carriage mounts the traction boot slides along an arch-shaped track. The carriage can be positioned discreetly along the track, typically corresponding to every 5° within its range. The patented arch-shaped track design is similar to the shape of the hip joint rotational center. As the patient’s leg is smoothly guided along the track, consistent orthopedic traction is applied at all positions. Thus, compressive and tensile forces on the leg and hip are avoided.

Adduction/Abduction

As an orthopedic surgery positioning device, the ARCH Orthopedic Leg Positioner provides 360° of AB- or AD-duction; however, +/- 60° is the typical clinically appropriate range. Adduction/Abduction is controlled in increments of 10 degrees in either direction.

Specifications

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Training Certification Program

Are you interested in becoming certified to use the ARCH or even becoming a trainer of other users? Welcome to the ARCH Training Certification Program! We are glad you are interested in becoming an ARCH-certified user or trainer. STERIS’ certification program for users and trainers is divided into the three tiers below.

Level 1: ARCH Users

Level 1 was created for medical professionals who operate the device in the operating room. Level 1 equipment users should know all the information in the following documents. The Level 1 Certification Form can be used if necessary but is not required.

1. ARCH In-Service Video
2. ARCH Pre-op Checklist
3. DAA Top 360 In-Service Summary (if applicable)

Level 2: Trainers

Level 2 was created for advanced users, STERIS employees, and third-party representatives who will be in-servicing Level 1 users on the proper use of the ARCH. Level 2 trainers must meet all Level 2 Certification Form requirements.

Level 3: Advanced Trainers

Level 3 was created for STERIS employees and third-party representatives ONLY with the certification to train Level 2 trainers. In addition to all requirements necessary to achieve Level 2 certification, Level 3 trainers must also meet the requirements outlined in the Level 3 Certification Form.

Please contact Innovative Orthopedic Technologies to start your certification training.

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FAQs

Q: Do the ARCH and PURIST systems use a femur hook with a powered lift to elevate the femur?

A: No. Both the ARCH and PURIST systems use femoral support under the patient’s thigh, which acts as a fulcrum to elevate the proximal end of the femur during leg extension.

The Perineal Operative Post and DAA Top 360 accessories have femoral supports with variable heights. Increasing the height of the femoral support will increase the anterior movement of the proximal end of the femur during leg extension. The DAA Top 360 tabletop accessory offers the widest range of femoral support height adjustment, and the height can be changed intraoperatively through the drape.

Q: ARCH vs. PURIST, which product is best for me?

A: It depends on the surgeon’s preference and OR setting. We have PURIST and ARCH users who are very satisfied with the performance of their leg positioning system of choice. The PURIST is specifically designed for anterior hip replacement, and the ARCH can be used for anterior hip replacement and femoral fractures.

ARCH Advantages

• Stainless steel C-arch track fully constrains the leg during extension and adduction
• More total rotation and adduction available
• Easily accessible flexion movements
• Adduction and abduction possible at neutral extension

PURIST Advantages

• Automatic traction release during extension
• Fast Track Hybrid System™ for simultaneous traction and rotation control, simplifying hip reduction and dislocation
• Smaller footprint
• Increased mobility
• Built-in drape holder
• All surgical functions can be completed by the PURIST operator in a standing position

For surgeons who currently use full-size fracture tables and are looking for firm, sturdy control of the leg, we usually recommend the ARCH. For surgeons looking for a light, ergonomic, staff-friendly device, we typically recommend the PURIST. However, this is highly variable and depends on individual surgeon preferences, staff familiarity with the anterior approach, surgical volume, geographic location, facility size, etc. Contact Us to get the best recommendations for your specific needs.

Q: Can the ARCH or PURIST be used for hip arthroscopy?

A: Neither the ARCH nor the PURIST is designed for hip arthroscopy.

Are the ARCH and the PURIST compatible with any surgical table?

A: Yes, ARCH and PURIST are compatible with most general surgical tables. Over the last 10+ years, we have had very few situations in which our accessories did not fit!

Both our ARCH and PURIST systems are free-standing devices, and the accessories attach to the OR table siderails. Siderail dimensions can vary depending on the country, but this is not a problem. We offer various siderail attachments to fit various sizes of siderails. Our accessories are currently used in markets with different sizes of siderails, such as the USA, Europe, Australia, and Japan.

There is no need to pair our systems with a traction table. More basic OR tables, such as the STERIS 5095 General Surgical Table or the STERIS 4095 General Surgical Table, are preferred because they have fewer metal structures that could interfere with intraoperative imaging.

What is the best way to set up the OR table using the ARCH or PURIST?

A: Follow all requirements of the OR table used. We recommend orienting the table when possible so the long portion of the table base will be situated under the patient’s center of gravity and pointing toward the ARCH or PURIST. This usually provides increased stability. Ensure there is adequate clearance for the C-arm to maneuver into place. Watch the ARCH In-Service Video or PURIST In-Service Video for more info.

How are the ARCH and the PURIST classified in my country?

According to FDA and MDR regulations, ARCH and PURIST are classified as class I medical devices.

Q: What is the maximum patient weight for these devices?

A: The ARCH, PURIST, DAA Top 360, OLH, and POP are all designed for patient weights up to 500 lb. (227 kg). However, if the patient weight limit of the OR table is lower than this, the table weight limit takes priority. Ensure to check the orientation of the OR table, as different orientations often have different weight limits. Refer to the OR table user manual to ensure you operate within their specifications.

Q: Does the ARCH have patient height requirements?

Yes. The ARCH can accommodate patients between ~4’10” (147 cm) and ~6’8” (203 cm). As leg length and total height are not perfectly correlated, these are estimated heights.

Q: What maximum patient height can the Opposite Leg Holder accommodate?

About 7’5” (226cm). As leg length and total height are not perfectly correlated, this is an estimated maximum height.

Q: Do you have different traction boot sizes?

Yes. The ARCH, PURIST, and Opposite Leg Holder (OLH) all have a size medium boot in their standard configurations. We also offer a size small boot that can be purchased separately.

Q: What is the footprint of the ARCH?

A: 80 cm (2’8”) x 158 cm (5’2”)

Q: Is the black perineal post pad (of the POP or DAA Top 360) reusable?

A: Yes, the black perineal post pad is designed to be reusable. Its closed-pore design allows the sealed surface to be easily cleaned. However, we recommend replacement after every 10 cases.

Are single-use accessories required with ARCH and PURIST?

No. However, we offer a variety of single-use products that increase patient safety and efficiency, especially in Direct Anterior THA cases.

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