Relative Clamp for Bunion Surgery Notes

Bunion Surgery: Lapidus Procedure and MIS

Surgeon's Experience and the Relative Clamp

  • Experienced foot and ankle surgeon (20 years) in a DPM training ortho group.
  • Performs a high volume of bunion surgeries due to patient referrals.
  • Elective surgery focus shifting towards bunion procedures.
  • Experience with various Lapidus procedure techniques:
    • Handheld reduction.
    • Point-to-point clamps.
    • Company X and Company Y clamps.
  • Designed the Relative Clamp to address shortcomings of existing clamps.

Design Goals of the Relative Clamp

  • Radiolucent: Allows visualization of sesamoids and reduction under X-ray.
  • No Incisions: Unlike other clamps that require additional incisions.
  • Quick and Easy Application: Designed for use even by second-year residents.
  • Three-Plane Correction: Corrects deformity in all three anatomical planes (frontal, transverse, sagittal).
  • Correction Across the Fusion Site: Facilitates accurate reduction at the fusion site.
  • Unobstructed Hardware Placement: Designed to stay out of the way during hardware placement.
  • Avoids Loss of Correction: Addresses the issue of losing correction when removing clamps for hardware placement.
  • Sterile Pack: Comes in a sterile package.

Relative Clamp Technique

  • Initial Pin Placement:
    • One pin in the second metatarsal.
    • One pin in the first metatarsal, inserted at a 3030 to 4545 degree angle.
  • Frontal Plane Correction: Rotate the clamp to correct frontal plane deformity and lock down thumb screw number one (over toe number one).
  • Transverse Correction: Squeeze the tabs to reduce the intermetatarsal angle (IMA) and lock down thumb screw number two.
  • Sagittal Plane Correction: The clamp allows for sagittal plane correction to eliminate gapping. Lock down thumb screws number three and number four.
  • Compression: The clamp allows for distraction and compression across the joint. A guide wire is typically placed, followed by a compression screw for joint compression.
  • Hardware Placement: The clamp is designed to be out of the way for plate and screw placement.

Surgical Technique Details

  • Incision Size: Approximately a three-centimeter incision over the first TMT joint is sufficient for plate placement.
  • Cuneiform Obliquity Removal:
    • Critical to remove the obliquity of the cuneiform to prevent bounce-back.
    • Insert a wire perpendicular to the segment of the tarsal and use a saw parallel to the wire to remove the obliquity.
    • Studies suggest 4040 to 5050 percent of first ray motion comes from the navicular-cuneiform joint, contributing to potential bounce-back.

Pin Placement Guidelines

  • Mark the first metatarsophalangeal joint (MPJ) and draw a line five millimeters behind it.
  • Palpate the second metatarsal to determine the pin insertion point.
  • Ensure the clamp is straight across the foot and not canted.
  • Insert the second metatarsal pin in the center of the metatarsal.
  • Verify the pin is in the distal part of the slot, allowing for dorsiflexion.
  • Avoid skewering the sesamoids with the first metatarsal pin to allow for frontal plane rotation.

Post-Reduction and Fixation

  • Take an X-ray to visualize the sesamoid position and confirm adequate correction.
  • Apply fixation of choice (staples, screws, plate and screws) while the clamp remains in place.

Advantages of the Relative Clamp

  • Quick, simple, and easy to use.
  • Radiolucent, allowing for intraoperative visualization.
  • No additional incisions required.
  • Corrects in all three planes.
  • Out of the way for hardware placement.
  • Allows compression across the joint.
  • Comes in a sterile pack.

MIS (Minimally Invasive Surgery) Indications and the Relative Clamp

  • The Relative Clamp can be used for MIS bunion correction.
  • Technique involves performing a transverse osteotomy from the third to the first metatarsal.
  • The clamp is used to frontal plane rotate and reduce the capital fragment.
  • Thumb screws number three and four are locked down to maintain sagittal plane position.
  • Helpful for surgeons new to MIS or those without assistance, acting as an extra set of hands.
  • Addresses the common challenge in MIS of holding the capital fragment in the desired position during screw placement, preventing plantarflexion.

Off-Label Uses of the Relative Clamp

  • Lisfranc fracture dislocations: A pin in the cuneiform and second metatarsal are secured with the clamp.

Surgeon Feedback on the Relative Clamp

  • Experienced surgeons may not find it necessary but acknowledge its benefits.
  • Benefits include acting as an extra set of hands and maintaining first ray position until fixation.
  • Users reported better correction compared to point-to-point clamps or temporary fixation methods.
  • Can help avoid elevation of the first ray or incomplete removal of the obliquity of the cuneiform.

Lapidus vs. MIS Procedures

  • The trend shows a shift from traditional Chevron/Scarf osteotomies towards Lapidus and MIS procedures.
  • Estimates suggest less than half are traditional, 25253030% Lapidus, and a growing percentage of MIS.
  • MIS and Lapidus are increasingly replacing traditional Chevron procedures.

Minimally Invasive Chevron

  • One-centimeter incision technique for mild to 1818 degree intermetatarsal angle(IMA) corrections.
  • The guide sits on the side of the foot.
  • Involves pre-drilling for screw placement from the top to ensure accurate fragment positioning.
  • Capital fragment is moved over, held with a Steinmann pin, and fixed with a screw.
  • Not suitable for patients with hypermobility or significant frontal plane deformity.
  • Provides an easier entry point into MIS by allowing surgeons to visualize the cuts in their initial cases.

Future Products and Systems

  • Fourth Quarter: Sterile pack Lapidus system with the Relative Clamp, two screws, and two staples (dorsal and medial).
  • First Quarter: Sterile pack plate and screws system with the clamp, and potentially the cutting guide (pending legal clearance).
  • Two/Three TMT fusion system.

Cutting Guide

  • Designed to address the obliquity of the cuneiform, ensuring a straight foundation for the first metatarsal.
  • The body of the cutting guide aligns with the second ray.
  • A radio-opaque marker indicates alignment on X-ray.
  • A pin is inserted in the second metatarsal.
  • The cuts in the cuneiform are dialed in using a thumb screw.
  • An olive wire aids in sagittal plane cut positioning.
  • Slots provide stability during cuneiform cuts.
  • Surgeons can customize the cut depth based on the intermetatarsal angle (IMA).
  • The cutting guide can be paired with the Relative Clamp.
  • The cutting guides uses two pins.

Patents

  • Patents line ongoing.
  • Provisional patent for the cutting guide.
  • Continued investments in patents for protection.