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 30 to 45 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 40 to 50 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, 25–30% 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 18 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.