12.07.2014 Views

Ascension® pyroCarbon Lunate

Ascension® pyroCarbon Lunate

Ascension® pyroCarbon Lunate

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

surgical<br />

technique<br />

Ascension Orthopedics does not recommend a particular<br />

surgical technique when using the implant. Proper surgical<br />

techniques are necessarily the responsibility of the medical<br />

profession. Each surgeon must evaluate the appropriateness<br />

of the surgical technique used based on personal medical<br />

training and experience. A description of the procedure<br />

used by Prof. John Stanley and Dr. Steven Moran follows.<br />

Alternative Capsulotomy:<br />

The wrist is palpated and marked prior to elevation<br />

of the dorsal capsular flap, which will then provide access<br />

to the radiocarpal and midcarpal joints. The distal margin<br />

of Lister’s tubercle is identified, and a J shape line is drawn<br />

toward the dorsal tubercle of the triquetrum. An incision<br />

is then made to follow this line, extending from the distal<br />

margin of Lister’s tubercle obliquely toward the dorsal tubercle<br />

of the triquetrum. This incision is designed to split the fibers<br />

of the radiocarpal ligament and preserve the branches of the<br />

posterior interosseous nerve within the flap. The capsular<br />

flap is then raised tangentially off the dorsal surface of the<br />

scaphoid, lunate, triquetrum, and the proximal portion of the<br />

Alternative<br />

Capsulotomy<br />

Step 7: Tendon Stabilization and Closure<br />

A drill hole is created in the scaphoid by passing a K-wire<br />

from dorsal to palmar. The K-wire is started in the proximal<br />

dorsal base of the scaphoid and then drilled in an oblique<br />

fashion to exit the bone palmarly just proximal to the distal<br />

tubercle. The position of the K-wire is confirmed with X-rays.<br />

The K-wire tract is then enlarged with a 2.9-3.5 mm<br />

cannulated drill to allow for tendon passage Figure 7.<br />

A similar procedure is performed at the triquetrum. Here the<br />

K-wire is passed from the dorsal ulnar margin to the central<br />

aspect of radial surface of the triquetrium. The K-wire tract<br />

is then enlarged with a cannulated drill Figure 8.<br />

Figure 7<br />

For a description of Dr. Robert Beckenbaugh's surgical procedure<br />

for <strong>Lunate</strong> stabilization with suture anchors, please contact<br />

Ascension Orthopedics at 1-512-836-5001.<br />

Step 1: Skin Incision<br />

Make a 7-10 cm midline dorsal longitudinal incision<br />

across the radiocarpal area Figure 1. The retinaculum is<br />

incised over the extensor pollicis longus. Retinacular flaps<br />

are raised and opened from the 2nd to the 5th extensor<br />

compartment. Take care to identify and protect the<br />

dorsal radial and ulnar sensory nerves Figure 2. The<br />

extensor pollicis longus is retracted radially while the extensor<br />

digitorum communis tendons are retracted ulnarward.<br />

Figure 1<br />

capitate. If additional exposure is required, an additional cut<br />

may be made in line with the fibers of the dorsal intercarpal<br />

ligament extending from the triquetrum towards the trapezium.<br />

This will further expose the neck of the capitate and the waist<br />

of the scaphoid bone, if necessary for completion of the<br />

surgical procedure Figure 3B.<br />

Step 3: Resection of the <strong>Lunate</strong><br />

Place a small towel beneath the palmar aspect of the wrist in<br />

order to induce a small degree of wrist flexion Figure 4.<br />

The lunate is resected with great care to remove the lunate<br />

in-total if possible, to allow for easy assessment of implant<br />

size. If the lunate has experienced significant collapse or<br />

Figure 3B<br />

The FCR tendon is now passed sequentially through the<br />

scaphoid into the lunatectomy space. Passage can be<br />

facilitated by using an 18 gauge spinal needle and a tendon<br />

passer (Chia Passer, DePuy), or a simple wire loop.<br />

Before inserting the implant, the wound is thoroughly irrigated<br />

with saline solution to remove all debris. The implant should<br />

not be handled with metal instruments. The tendon is then<br />

passed through the dorsal hole in the <strong>Lunate</strong>. Note that the<br />

short flat surface articulates with the scaphoid and the long<br />

surface articulates with the triquetrum Figure 9. The tendon is<br />

then passed through the triquetrum. Tendon passage is again<br />

facilitated with the aid of a tendon passer or wire loop.<br />

Figure 8<br />

Scaphoid<br />

Surface<br />

Figure 9<br />

Triquetral<br />

Surface<br />

Step 2: Capsulotomy<br />

Specific landmarks are identified and palpated on the wrist.<br />

These mark the placement of the capsular incision. The dorsal<br />

radio lunotriquetral ligament arises from the radius between<br />

Lister's tubercle and the dorsal aspect of the radius as far<br />

as the distal radioulnar joint. Caution is taken to protect the<br />

terminal branch of the posterior interosseous nerve.<br />

Landmarks:<br />

1. The midpoint of the dorsal radiocarpal ligament<br />

attachment to the radius.<br />

2. The dorsal tubercle of the triquetrum.<br />

3. The sulcus between the scaphoid and the trapezoid.<br />

These landmarks are marked, and the surgeon simply connects<br />

the dots with a full thickness incision. This capsular incision<br />

reveals the longitudinally split fibers of the DIC and DRC<br />

ligaments. Once the ligament-splitting incisions are made, the<br />

capsulotomy can be completed by following the dorsal rim of<br />

the radius to the level of the styloid process. When the radiocarpal<br />

capsulotomy is complete, the radially based flap of<br />

capsule is tangentially elevated off the dorsal surfaces of the<br />

capitate and lunate Figure 3A.<br />

After the capsulotomy has been created, the surgeon should<br />

closely examine the scaphoid fossa within the radius. If there<br />

is evidence of significant arthritis, the procedure should be<br />

abandoned for an alternative wrist salvage procedure, as<br />

ongoing pain will continue at the radioscaphoid fossa despite<br />

replacement of the lunate.<br />

Figure 2<br />

Figure 3A<br />

3<br />

1<br />

2<br />

fragmentation, templating against the normal wrist is<br />

recommended prior to starting the case.<br />

Step 4: Sizing<br />

The PyroCarbon <strong>Lunate</strong> comes in 5 sizes for the right and left<br />

hand. The deep concavity of the lunate straddles the head of<br />

the capitate distally. The shorter flat surface articulates with<br />

the scaphoid and the longer surface with the triquetrum Figure 5.<br />

The Drill Guides provided can be used to help estimate the<br />

implant fit on the surfaces of the triquetrum, scaphoid, and<br />

capitate Figure 6. Radiopaque <strong>Lunate</strong> Trials are also used<br />

to help with determining the correct size implant. Implant<br />

sizing should always start with the smallest trial incrementing<br />

up in size until a comfortable fit in the lunatectomy space is<br />

obtained. Take care to avoid overstuffing the joint, as this can<br />

potentially distract the first carpal row and could result in<br />

excessive implant force loading and displacement.<br />

Step 6: Harvesting the Tendon<br />

Attention is directed to the distal radial flexor surface of the<br />

forearm. Two small transverse incisions permit access to harvest<br />

one-third of the flexor carpi radialis tendon (FCR) from its<br />

musculotendinous junction to the tuberosity of the scaphoid.<br />

The remaining FCR muscle/tendon unit retains function as<br />

an important wrist flexor. Surgeons may use their preferred<br />

technique for FCR harvest; however the final tendon should<br />

be approximately 8-10 cm in length and approximately<br />

0.4-0.8 cm in diameter. The tendon will now be passed<br />

through the scaphoid, lunate prosthesis, and triquetrum.<br />

Figure 4<br />

Larger<br />

Triquetral<br />

Surface<br />

Smaller<br />

Scaphoid<br />

Surface<br />

Figure 5<br />

Scaphoid<br />

Figure 6<br />

Triquetrum<br />

NOTE: The usage of metal sutures or wires for<br />

implant fixation is contraindicated.<br />

The remaining tendon is now passed through the ulnar<br />

margin of the dorsal capsular flap. The tendon is placed<br />

on tension and the position of the lunate is now examined<br />

under X-ray. Once the tendon has been tensioned the<br />

dorsal flap is secured to the triquetrum with the aid of a<br />

suture anchor Figures 10 & 11. The FCR tendon is now<br />

tensioned and held in place using the same suture anchor.<br />

The remaining tendon can be cut short or weaved into the<br />

remaining wrist capsule to further augment its stability.<br />

Several heavy non-resorbable sutures are now used to<br />

imbricate the FCR to the dorsal capsule. The capsular<br />

flap is repaired with 2-0 Vicryl suture and the extensor<br />

retinaculum is repaired with 3-0 Vicryl suture. The skin<br />

incisions are now closed with 4-0 nylon suture.<br />

The wrist may be placed through a range of motion, and<br />

the <strong>Lunate</strong> position can be verified with X-ray imaging.<br />

Postoperative Care<br />

The extremity is elevated for 1-2 days, and the patient is<br />

instructed to move the shoulder and fingers. A sugar tong<br />

splint is applied for the first 3-5 days. This is then changed<br />

to a short arm cast. Wrist immobilization is maintained<br />

for 6-8 weeks. Skin suture can be removed at 2 weeks.<br />

Postoperative therapy should include isometric gripping<br />

and movements of the shoulder. Full usage of the wrist<br />

is resumed at 12 weeks, unless an intercarpal fusion<br />

was performed, which requires a longer casting period.<br />

Figure 10<br />

Figure 11


Cyclic<br />

Wear test<br />

Against<br />

Bone<br />

penetration rate<br />

(nanometer/cycle)<br />

0.2<br />

<strong>pyroCarbon</strong><br />

elastic<br />

Modulus<br />

(Gpa)<br />

23<br />

Cortical Bone<br />

4.3<br />

CoCr Alloy<br />

29.4<br />

<strong>pyroCarbon</strong><br />

30.4<br />

Titanium<br />

105<br />

Titanium<br />

34.7<br />

Zirconia<br />

Wear testing shows<br />

that PyroCarbon-on-bone<br />

articulation wear is<br />

significantly less than<br />

that of medical grade<br />

metals and ceramics.<br />

210<br />

Zirconia<br />

The elastic modulus<br />

of PyroCarbon closely<br />

matches that of cortical<br />

bone.<br />

design<br />

interpositional<br />

➤ maintains mobility<br />

➤ preserves the scaphoid<br />

and triquetrum<br />

➤ bone-friendly material<br />

➤ open pathway for revision<br />

system overview<br />

Design Description<br />

The Ascension ® PyroCarbon<br />

<strong>Lunate</strong> is an anatomically<br />

designed lunate replacement<br />

with essentially the same<br />

shape as the native lunate<br />

bone. The <strong>Lunate</strong> implant<br />

acts as an articulating<br />

spacer to maintain the relationship of adjacent carpal<br />

bones after excision and to maintain mobility of the wrist.<br />

The articular concavity that captures the capitate is more<br />

exaggerated to enhance stability. The <strong>Lunate</strong> implant has<br />

two holes which allow fixation of the implant by tendon or<br />

suture to the adjacent scaphoid and triquetrum bones to<br />

provide temporary postoperative stability while a capsular<br />

fibrosis system forms around the implant providing additional<br />

stability. The Ascension PyroCarbon <strong>Lunate</strong> is constructed<br />

of a high strength On-X ® PyroCarbon layer deposited on a<br />

graphite substrate. The graphite is impregnated with tungsten<br />

making the <strong>Lunate</strong> radiopaque. The implant is available in<br />

5 sizes for use in left or right applications.<br />

Indications<br />

Ascension ®<br />

At Ascension Orthopedics,<br />

we are dedicated to transforming<br />

the surgical experience.<br />

PyroCarbon <strong>Lunate</strong><br />

Implants<br />

Catalog number<br />

LUN-710-01<br />

LUN-710-02<br />

LUN-710-03<br />

LUN-710-04<br />

LUN-710-05<br />

Instrumentation<br />

Catalog number<br />

INS-710-00<br />

Set includes:<br />

Radiopaque Trials<br />

Sizing Guides<br />

Additional solutions<br />

for the hand:<br />

Ascension ®<br />

MCP/PIP<br />

PyroCarbon<br />

Total Joints<br />

Ascension ®<br />

MCP/PIP<br />

Pre-flexed<br />

Silicone Joints<br />

Ascension ®<br />

PyroCarbon<br />

CMC<br />

Arthroplasty<br />

First Choice ®<br />

DRUJ: Partial<br />

& Modular<br />

Ulnar Head<br />

description<br />

Size 01 <strong>Lunate</strong><br />

Size 02 <strong>Lunate</strong><br />

Size 03 <strong>Lunate</strong><br />

Size 04 <strong>Lunate</strong><br />

Size 05 <strong>Lunate</strong><br />

description<br />

Instrument Set<br />

Ascension ®<br />

PyroCarbon <strong>Lunate</strong><br />

tendon stabilization<br />

surgical technique<br />

Transforming Extremities <br />

Histological examination<br />

after 7 mos. of articulation<br />

with PyroCarbon PHS<br />

showed a layer of healthy<br />

fibrous pseudocartilage.<br />

Sample had no evidence<br />

of particulate synovitis. 2<br />

The PyroCarbon <strong>Lunate</strong> may be considered for use<br />

in the following situations:<br />

• Presence of avascular necrosis – Kienböck’s disease<br />

• Localized osteoarthritic changes of the radiolunate<br />

fossa or capitellar head<br />

• Long-standing lunate dislocations<br />

Contraindications<br />

• Acute or chronic infection<br />

• Radial scaphoid arthritis<br />

• Gross carpal instability<br />

Ascension Orthopedics, Inc.<br />

8700 Cameron Road<br />

Austin, Texas 78754<br />

512.836.5001 Ph<br />

877.370.5001 TFP<br />

512.836.6933 Fax<br />

888.508.8081 TFF<br />

customerservice@ascensionortho.com<br />

www.ascensionortho.com<br />

Caution: U.S. federal law restricts this device<br />

to sale by or on the order of a physician.<br />

LC-04-717-003 rev A<br />

©2009

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!