Fixation Device and Method of Use for a Ludloff Osteotomy Procedure

1 . An internal fixation device for use in fixation of a metatarsal bone, the fixation device comprising:

a U-shaped plate having a straight section interconnecting a pair of opposed legs which are bent relative to the straight section,

wherein the straight section is formed therethrough with a set of non-threaded holes, and

wherein the legs are formed therethrough with a set of threaded holes.

2 . The internal fixation device of claim 1 , wherein the straight section includes a pair of spaced apart non-threaded holes.

3 . The internal fixation device of claim 1 , wherein each leg has a single threaded hole.

4 . The internal fixation device of claim 1 , wherein the non-threaded holes are located at opposite ends of the straight section.

5 . The internal fixation device of claim 1 , wherein the threaded holes are located adjacent outermost edges of the legs.

6 . The internal fixation device of claim 1 , wherein, in a top view of the plate, the legs are bent rearwardly of the straight section.

7 . The internal fixation device of claim 1 , wherein one of the legs has a length which is longer than the length of the other leg.

8 . The internal fixation device of claim 1 , wherein the straight section has a thickness that is greater than the thickness of the legs to allow bending of the legs beyond an initial bent curvature thereof.

9 . The internal fixation device of claim 1 , wherein the non-threaded holes define temporary and final fixation holes adapted to be used in fixation of the metatarsal bone.

10 . The internal fixation device of claim 1 , wherein the threaded holes define final fixation holes adapted to be used in fixation of the metatarsal bone.

11 . The internal fixation device of claim 1 , wherein the non-threaded holes are configured to receive non-locking screws therein.

12 . The internal fixation device of claim 1 , wherein the threaded holes are configured to receive locking screws therein.

13 . The internal fixation device of claim 1 , wherein the threaded holes are differently sized to receive differently sized locking screws.

14 . The internal fixation device of claim 1 , wherein one of the legs is formed with a temporary fixation hole adapted to be used in fixation of the metatarsal bone.

15 . The internal fixation device of claim 1 , wherein the plate is configured to extend across an osteotomy of the metatarsal bone.

16 . The internal fixation device of claim 1 , wherein the straight section is configured to engage a dorsal portion of the metatarsal bone.

17 . The internal fixation device of claim 1 , wherein the legs are configured to engage a medial portion of the metatarsal bone.

18 . The internal fixation device of claim 1 , wherein the plate is configured to be engaged on the metatarsal bone during and after a Ludloff osteotomy.

19 . An internal fixation device for use in fixation of a metatarsal bone, the fixation device comprising:

a U-shaped plate having a straight section interconnecting a pair of proximal and distal opposed legs which are bent relative to the straight section, wherein the straight section is formed therethrough with a proximal non-threaded hole and a distal non-threaded hole, and wherein each leg is formed therethrough with a threaded hole at a distal end of each leg;

a proximal non-locking bone fastener received in the proximal non-threaded hole;

a distal non-locking bone fastener secured in the distal non-threaded hole;

a proximal locking bone fastener received in the threaded hole of the proximal leg; and

a distal locking bone fastener received in the threaded hole of the distal leg.

20 . The internal fixation device of claim 19 , wherein each bone fastener is a cannulated screw adapted to receive a K-wire.

21 . The internal fixation device of claim 19 , wherein the non-locking bone fasteners includes shafts which are partially threaded along lower portions thereof.

22 . The internal fixation device of claim 19 , wherein the locking bone fasteners include shafts which are threaded along substantially entire lengths thereof.

23 . The internal fixation device of claim 19 , wherein the walls forming non-threaded holes are configured such that the bone fasteners received therein toggle to assume a plurality of angles relative to central axes of the non-threaded holes.

24 . The internal fixation device of claim 19 , wherein the straight section and the non-locking bone fasteners are configured to engage a dorsal portion of the metatarsal bone.

25 . The internal fixation device of claim 19 , wherein the legs and locking bone fasteners are configured to engage a medial portion of the metatarsal bone.

26 . The internal fixation device of claim 19 , wherein the plate and bone fasteners are constructed of titanium alloy Ti-6A1-4V.

27 . A surgical method of fixating a Ludloff osteotomy of a first metatarsal bone to correct a hallux valgus deformity utilizing the internal fixation device of claim 1 .

28 . A surgical method of fixating a Ludloff osteotomy of a first metatarsal bone to correct a hallux valgus deformity, the method comprising the steps of:

(a) providing a U-shaped plate configured to be engaged on a first metatarsal bone across the Ludloff osteotomy, the plate having a straight section interconnecting a pair of proximal and distal opposed legs which are bent relative to the straight section, wherein the straight section is formed therethrough with a proximal non-threaded hole and a distal non-threaded hole, and wherein each leg is formed therethrough with a threaded hole at a distal end of each leg;

(b) entering the tissues of the foot affected with the hallux valgus deformity using a medial incision at a site on the first metatarsal bone to gain exposure thereto;

(c) from the medial site of the first metatarsal bone, performing a partial three-quarter Ludloff osteotomy at the site extending obliquely from dorsal-proximal to plantar-distal;

(d) positioning the plate across the partially osteotomy cut such that the straight section engages a dorsal portion of the first metatarsal bone, and the legs engage a medial portion of the first metatarsal bone;

(e) temporarily fixating the plate at a proximal-dorsal location of the partial cut by inserting a proximal non-locking screw through the proximal non-threaded hole of the plate into the first metatarsal bone;

(f) completing the osteotomy cut forming dorsal and plantar metatarsal fragments with the plate and proximal non-locking screw engaged with the first metatarsal bone;

(g) using the proximal non-locking screw as a pivot axis, manipulating the metatarsal fragments to obtain hallux valgus correction;

(h) inserting a distal non-locking screw through the distal non-threaded hole of the plate into the first metatarsal bone;

(i) tightening the proximal and distal non-locking screws to secure the straight section of the plate against the dorsal portion of the first metatarsal bone;

(j) inserting locking screws in the threaded holes of the proximal and distal legs;

(k) tightening both locking screws to secure the proximal and distal legs to the medial portion of the first metatarsal bone and complete fixation across the osteotomy cut; and

(l) excising remaining medial bone caused by correction in step (g) and closing the site.

29 . The method of claim 28 , wherein, following tightening of both non-locking screws, the legs are further bent to adjust to the particular shape of the fragmented metatarsal bone.

30 . The method of claim 28 , wherein the step of manipulating the metatarsal fragments includes pulling the plantar metatarsal fragment medially and the dorsal metatarsal fragment laterally.

31 . The method of claim 28 , wherein the non-locking screws are fixed perpendicularly to the osteotomy cut to achieve compression with the plate across the osteotomy.

32 . The method of claim 28 , wherein the non-locking screws are angled up to 15° in the plate.

33 . The method of claim 28 , wherein the heads of the non-locking and locking screws lie flush with the plate upon tightening of both the locking and non-locking screws.