The Use of a Two-Piece Intramedullary Device for the Correction of a Hammertoe Deformity Authors: Julian McNees-Lambert, DPM; Gina M. Tomsho, DPM; Dustin M. Fox, DPM; John D. Peterson, DPM; Leslie P. Niehaus, DPM, FACFAS Purpose: A retrospective analysis was performed to analyze the procedure and results after implantation of the Nextra TM two-piece locking device for the correction of a hammertoe deformity. Methodology: A retrospective analysis of 25 two-piece intramedullary devices that were sur- gically implanted into 8 consecutive patients (ages 30-64) over a period of 10 months was performed. Pre-operative and post-operative AP radiographs, along with 3 month post-operative radiographs were analyzed. Patients were asked to rate their level of pre-operative and post-operative pain, as well as their overall satisfaction with their hammertoe correction. Attending surgeon was also in- terviewed in regard to his overall satisfaction, both with the procedure and the patient’s post-operative clinical results. Procedures: Pre-operatively, each of the 8 patients presented with metatarsalgia of the fore- foot and at least one rigidly contracted digit. In each case conservative therapy was unsuccessful in alleviating pain, and the patient wished to proceed with surgery. The hammertoe correction surgeries were performed under managed anesthesia care and local anesthesia. A dorsal incision was made over the prox- imal interphalangeal joint (PIPJ) and deepened through the subcutaneous tis- sue. A transverse tenotomy of the EDL was performed, and the capsular tissue was exposed. The capsule was transversely incised and the distal head of the proximal phalanx was freed of its ligamentous attachments. The head of the proximal phalanx and the base of the middle phalanx were resected with a bone saw. Next, a step drill (included in the kit) was hand drilled into the intramedul- lary canal of both the proximal and distal surfaces to create pilot holes.Then us- ing reversible driver the proximal phalanx implant was inserted, followed by the middle phalanx. Care must be taken to ensure the laser-etched arrow ends in the 12 o’clock position upon insertion. The implant is designed with the RevLock TM adjustable locking feature to click at 1.1mm intervals. There are 3 notches for locking. If the implant is not positioned correctly, the locking feature can be disengaged by rotating the middle phalanx 45 degrees and readjusting the position of either the implant or the digit. Closure of the surgical site was then performed in a standard manner. Patients were seen at day-3, day-10, day-21, and day-90 for post operative dressings, suture removal, radiographs, and dis- cussion of pain and overall satisfaction. The data was noted in each chart and analyzed. Results: A total of 25 fixed hammertoe deformities were corrected using a two-piece in- tramedually device. Intraoperatively, the two-piece device was very user friend- ly. (Fig. 1) There are 3 sizes of implants available to accommodate the differing digital morphologies. There was no increase in surgical time, when using this method. The mean follow-up time was 9 months. Clinical exam showed each corrected digit to maintain proper alignment in all body planes. Radiographs were taken postoperatively to confirm position of the implant as well as bony fusion. During the postoperative period there were no cases of wound compli- cation, infection, or deformity recurrence noted. In 2 of the 25 digits corrected, implant failure was noted at the first post-operative visit. In these digits the device separated at the locking mechanism; however, the digits still maintained adequate position and went on to fuse with no other complications. (Fig. 2) By use of serial radiographs, the attending surgeon was able to assess the posi- tion of the implant, and bony apposition and fusion of repair site. (Fig. 3) It was noted that some implants stabilized their position postoperatively, and provided additional compression. The attending surgeon also noted decreased digital swelling, as compared to other hammertoe corrective operations. 8/8 patients related that they experienced a reduction in pain after fully recover- ing from surgery. They were completely satisfied with the cosmetic appearance of the toes after the correction and were able to return to full mobility and nor- mal shoe gear by the 3 month follow-up appointment. Due to their satisfaction, some patients underwent additional hammertoe correction with this system. Additionally, no devices necessitated removal. Analysis & Discussion: The use of a two-piece intramedullary implant for arthrodesis of the PIPJ has advantages and disadvantages. Like other internal hammertoe devices, there is no risk of post operative pin tract infections. This two-piece intramedullary device provided a better cosmetic appearance. All patients experienced minimal post-operative pain. Twenty-four of the twenty-five digits fused at the PIPJ level in normal healing time. There was a post-operative history of trauma noted to the digit, which may explain its disengaged position. Easy removal and repo- sitioning is an additional advantage. Disadvantages include the possibility of decreased patient compliance. Since there is no external hardware, it can not be used to fuse the DIPJ, nor does this implant allow the surgeon the ability to stabilize the MPJ if desired. The cost of this implant must also be considered. Literature Review: Fixed flexion deformity of the PIPJ without hyperextension of the MTPJ is one of the most common foot deformities, with many surgical options available for correction. 1 The surgical gold standard therapy for a symptomatic hammertoe is a PIPJ arthrodesis. 2 It is common for today’s podiatric surgeon to use either K-wire, screw or other implant device to fix and maintain the corrected defor- mity. Konkel et al. studied the effects of absorbable implants on patient satis- faction. They found that with the use of a stiffer poly-L-lactate Trim-it Drill Pin, there are higher fusion rates, less medial/lateral angulation and a high patient satisfaction rate of 96.5%. Another recent study presented results of 3 patients who had corrective surgery utilizing the Pro-Toe TM VO implant system. They found that all 3 patients healed without any complications and all corrected toes maintained appropriate sagittal, coronal and frontal plane alignment, due in part to its barbed design. 3 Ellington et al. studied the use of the StayFuse TM 2-piece device in 47 digits, and found that overall alignment was maintained in 82% of the cases. 4 They felt another advantage to this device was its rela- tively low cost, when compared to other implant systems. In conclusion, there are many implant systems available for hammertoe correction, and the podiat- ric surgeon must understand the benefits and drawbacks to each system in his selection. References: 1) Kunkel, KF, Sover, ER, Menger, AG, Halberg, JM. Hammertoe Correction Using an Absorable Pin. Foot and Ankle International. Vol. 32 No. 10: 973-978, 2011. 2) Harmonson, JK, Harkless, LB. Operative Procedures for the Correction of Hammertoe, Claw Toe and Mallett Toe: a Literature Review. Clinical Podiatry Medince and Surgery. 13:211-220, 1996. 3) Witt, BL, Hyer, CF. Treatment of Hammertoe Deformity Using a One-Piece Intramedullary Device: A Case Series. The Journal of Foot & Ankle Surgery. 51:450-456, 2012. 4) Ellington, JK, Anderson, RB, Davids, H, Cohen, BE, Jones, CP. Radiographic Analysis of Proximal Interphalangeal Joint Arethrodesis With an Intramedullary Fusion Device for Lesser Toe Deformities. Foot and Ankle International. Vol. 31, No. 5: 372-376, 2010. Fig 1. The two piece intramedullary device Fig 2. In digits 2 and 4 the implant is not engaged in a locked position. Bony fusion and adequate position are noted. Fig 3. Various locking positions of the implant
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The Use of a Two-Piece Intramedullary Device for the Correction of a Hammertoe DeformityAuthors: Julian McNees-Lambert, DPM; Gina M. Tomsho, DPM;
Dustin M. Fox, DPM; John D. Peterson, DPM; Leslie P. Niehaus, DPM, FACFAS
Purpose: A retrospective analysis was performed to analyze the procedure and results after implantation of the Nextra TM two-piece locking device for the correction of a hammertoe deformity.
Methodology:A retrospective analysis of 25 two-piece intramedullary devices that were sur-gically implanted into 8 consecutive patients (ages 30-64) over a period of 10 months was performed. Pre-operative and post-operative AP radiographs, along with 3 month post-operative radiographs were analyzed. Patients were asked to rate their level of pre-operative and post-operative pain, as well as their overall satisfaction with their hammertoe correction. Attending surgeon was also in-terviewed in regard to his overall satisfaction, both with the procedure and the patient’s post-operative clinical results.
Procedures:Pre-operatively, each of the 8 patients presented with metatarsalgia of the fore-foot and at least one rigidly contracted digit. In each case conservative therapy was unsuccessful in alleviating pain, and the patient wished to proceed with surgery. The hammertoe correction surgeries were performed under managed anesthesia care and local anesthesia. A dorsal incision was made over the prox-imal interphalangeal joint (PIPJ) and deepened through the subcutaneous tis-sue. A transverse tenotomy of the EDL was performed, and the capsular tissue was exposed. The capsule was transversely incised and the distal head of the proximal phalanx was freed of its ligamentous attachments. The head of the proximal phalanx and the base of the middle phalanx were resected with a bone saw. Next, a step drill (included in the kit) was hand drilled into the intramedul-lary canal of both the proximal and distal surfaces to create pilot holes.Then us-ing reversible driver the proximal phalanx implant was inserted, followed by the middle phalanx. Care must be taken to ensure the laser-etched arrow ends in the 12 o’clock position upon insertion. The implant is designed with the RevLock TM adjustable locking feature to click at 1.1mm intervals. There are 3 notches for locking. If the implant is not positioned correctly, the locking feature can be disengaged by rotating the middle phalanx 45 degrees and readjusting the position of either the implant or the digit. Closure of the surgical site was then performed in a standard manner. Patients were seen at day-3, day-10, day-21, and day-90 for post operative dressings, suture removal, radiographs, and dis-cussion of pain and overall satisfaction. The data was noted in each chart and analyzed.
Results:A total of 25 fixed hammertoe deformities were corrected using a two-piece in-tramedually device. Intraoperatively, the two-piece device was very user friend-ly. (Fig. 1) There are 3 sizes of implants available to accommodate the differing digital morphologies. There was no increase in surgical time, when using this method. The mean follow-up time was 9 months. Clinical exam showed each corrected digit to maintain proper alignment in all body planes. Radiographs were taken postoperatively to confirm position of the implant as well as bony fusion. During the postoperative period there were no cases of wound compli-cation, infection, or deformity recurrence noted. In 2 of the 25 digits corrected, implant failure was noted at the first post-operative visit. In these digits the device separated at the locking mechanism; however, the digits still maintained adequate position and went on to fuse with no other complications. (Fig. 2)
By use of serial radiographs, the attending surgeon was able to assess the posi-tion of the implant, and bony apposition and fusion of repair site. (Fig. 3) It was noted that some implants stabilized their position postoperatively, and provided additional compression. The attending surgeon also noted decreased digital swelling, as compared to other hammertoe corrective operations.
8/8 patients related that they experienced a reduction in pain after fully recover-ing from surgery. They were completely satisfied with the cosmetic appearance of the toes after the correction and were able to return to full mobility and nor-mal shoe gear by the 3 month follow-up appointment. Due to their satisfaction, some patients underwent additional hammertoe correction with this system. Additionally, no devices necessitated removal.
Analysis & Discussion:The use of a two-piece intramedullary implant for arthrodesis of the PIPJ has advantages and disadvantages. Like other internal hammertoe devices, there is no risk of post operative pin tract infections. This two-piece intramedullary device provided a better cosmetic appearance. All patients experienced minimal post-operative pain. Twenty-four of the twenty-five digits fused at the PIPJ level in normal healing time. There was a post-operative history of trauma noted to the digit, which may explain its disengaged position. Easy removal and repo-sitioning is an additional advantage. Disadvantages include the possibility of decreased patient compliance. Since there is no external hardware, it can not be used to fuse the DIPJ, nor does this implant allow the surgeon the ability to stabilize the MPJ if desired. The cost of this implant must also be considered.
Literature Review:Fixed flexion deformity of the PIPJ without hyperextension of the MTPJ is one of the most common foot deformities, with many surgical options available for correction.1 The surgical gold standard therapy for a symptomatic hammertoe is a PIPJ arthrodesis.2 It is common for today’s podiatric surgeon to use either K-wire, screw or other implant device to fix and maintain the corrected defor-mity. Konkel et al. studied the effects of absorbable implants on patient satis-faction. They found that with the use of a stiffer poly-L-lactate Trim-it Drill Pin, there are higher fusion rates, less medial/lateral angulation and a high patient satisfaction rate of 96.5%. Another recent study presented results of 3 patients who had corrective surgery utilizing the Pro-ToeTM VO implant system. They found that all 3 patients healed without any complications and all corrected toes maintained appropriate sagittal, coronal and frontal plane alignment, due in part to its barbed design.3 Ellington et al. studied the use of the StayFuseTM 2-piece device in 47 digits, and found that overall alignment was maintained in 82% of the cases. 4 They felt another advantage to this device was its rela-tively low cost, when compared to other implant systems. In conclusion, there are many implant systems available for hammertoe correction, and the podiat-ric surgeon must understand the benefits and drawbacks to each system in his selection.
References:1) Kunkel, KF, Sover, ER, Menger, AG, Halberg, JM. Hammertoe Correction Using an Absorable Pin. Foot and Ankle International. Vol. 32 No. 10: 973-978, 2011.
2) Harmonson, JK, Harkless, LB. Operative Procedures for the Correction of Hammertoe, Claw Toe and Mallett Toe: a Literature Review. Clinical Podiatry Medince and Surgery. 13:211-220, 1996.
3) Witt, BL, Hyer, CF. Treatment of Hammertoe Deformity Using a One-Piece Intramedullary Device: A Case Series. The Journal of Foot & Ankle Surgery. 51:450-456, 2012.
4) Ellington, JK, Anderson, RB, Davids, H, Cohen, BE, Jones, CP. Radiographic Analysis of Proximal Interphalangeal Joint Arethrodesis With an Intramedullary Fusion Device for Lesser Toe Deformities. Foot and Ankle International. Vol. 31, No. 5: 372-376, 2010.
Fig 1. The two piece intramedullary device
Fig 2. In digits 2 and 4 the implant is not engaged in a
locked position. Bony fusion and adequate position are noted.
Fig 3. Various locking positions of the implant
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