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Foreign Body Reaction Associated With Artelon: Report of Three Cases
SCIENTIFIC ARTICLE
Foreign Body Reaction Associated With Artelon: Report of Three Cases Paul M. Robinson, MBChB, LindsayT. Muir, MCh The Artelon carpometacarpal joint implant is a degradable interposition arthroplasty spacer intended for use in thumb carpometacarpal joint osteoarthritis. Recently there have been reported cases of foreign body reaction attributed to the Artelon implant, which raise concerns about the use of this implant. The implant’s manufacturers claim excellent biocompatibility. We report 3 cases of persistent pain after thumb carpometacarpal joint arthroplasty performed using Artelon implants. In all 3 cases that required removal of the Artelon implant and trapeziectomy to achieve subsequent symptom relief, foreign body–type reaction associated with the Artelon was seen histologically. (J Hand Surg 2011;36A:116–120. Copyright © 2011 by the American Society for Surgery of the Hand. All rights reserved.) Key words: Artelon, trapeziometacarpal joint, carpometacarpal joint, thumb, osteoarthritis.
T
O DATE, NO SINGLE surgical treatment has proved
to be universally superior in the management of carpometacarpal (CMC) joint osteoarthritis (OA).1 A variety of surgical solutions have been proposed to treat this difficult problem. The Artelon CMC implant (Artimplant AB, Gothenburg, Sweden) is a degradable interposition arthroplasty spacer intended for use in CMC joint OA. There have been 3 published trials comparing the Artelon CMC implant with tendon interposition arthroplasty for the treatment of CMC joint OA.2– 4 In these studies, several patients required revision of the implant for persistent pain, but no adverse histological reactions or infections were reported. However, recently there have been 2 reported cases of foreign body reaction attributed to the Artelon CMC implant and the Artelon scaphotrapeziotrapezoid implant,5,6 leading to debate about its use.7 The manFromtheSalfordRoyalNHSFoundationTrust,Salford,GreaterManchester,UnitedKingdom;andThe Queen Elizabeth Hospital King’s Lynn NHS Trust, King’s Lynn, Norfolk, United Kingdom. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Received for publication May 24, 2010; accepted in revised form October 1, 2010. Corresponding author: Paul M. Robinson, MBChB, care of Mr. Muir’s secretary, Department of Orthopaedics, Salford Royal Hospital NHS Foundation Trust, Stott Lane, Salford, Greater Manchester M6 8HD, UK; e-mail: [email protected]. 0363-5023/11/36A01-0021$36.00/0 doi:10.1016/j.jhsa.2010.10.001
116 䉬 © ASSH 䉬 Published by Elsevier, Inc. All rights reserved.
ufacturer claims excellent biocompatibility.8 We report 3 cases of foreign body reaction associated with the Artelon implant and the outcomes of revision trapeziectomy with a flexor carpi radialis tendon sling. CASE REPORT Between October 2006 and June 2007, 3 patients underwent implantation of the Artelon spacer. The ages and genders of patients 1, 2, and 3 were 67 (male), 67 (female), and 36 (female), respectively. All preoperative radiographs showed Eaton stage III CMC joint OA. Patient 3 had posttraumatic OA after a previous intraarticular fracture of the thumb metacarpal that had been treated by percutaneous K-wire fixation. Patients 1 and 2 had gradual onset of idiopathic OA of the thumb CMC joint. A single experienced consultant hand surgeon performed all surgeries, with strict adherence to the manufacturer’s instructions.9 A single dose of prophylactic intravenous antibiotic was given on induction of anesthesia before the limb was exsanguinated and a tourniquet was applied and inflated. The CMC joint was approached via a dorsoradial incision and the articular surface of the trapezium (approximately 2 mm) was resected. The limbs of the implant were secured to the prepared bone using a titanium screw (Stryker Leibinger, Freiburg, Germany). A titanium washer (Stryker Leibinger) was used to increase the contact area be-
THREE CASES OF FOREIGN BODY–TYPE REACTION
FIGURE 1: Radiograph of patient 1 at 6 months after Artelon implantation.
tween the screw and the outer surface of the implant limbs. The capsular flap was repaired with Vicryl sutures (Ethicon, Gargrave, England). The skin was sutured with interrupted Ethilon (Ethicon) and a plaster cast was applied. Postoperatively, the thumb was immobilized in a below-elbow plaster cast for 5 weeks. Mobilization began 5 weeks postoperatively and was supervised by a physiotherapist. The protocol consisted of active exercises for the wrist, fingers, and radioulnar joint, active exercises for the thumb (flexion, opposition, and span), and light functional activity. At 8 weeks, resisted thumb apposition and opposition using a Thera-Band (Akron, OH) was introduced. Passive exercises for the wrist were used if full range of movement had not been achieved. During Artelon implantation, the CMC joint demonstrated OA in all 3 cases. We judged the postoperative radiographs for each patient to be satisfactory, with satisfactory screw positions (Figs. 1–3). All wounds healed normally and there were no cases of wound infection.
117
FIGURE 2: Radiograph of patient 2 at 8 months after Artelon implantation.
All 3 patients continued to have painful symptoms at the thumb base and a reduced range of movement. No patient developed erythema or had signs of infection. Postoperatively, the patients all reported pain that was at least equal to their preoperative symptoms. One patient (patient 2) developed further swelling at the thumb base and an increase in pain at approximately 12 weeks after surgery. For these reasons and after failure of conservative measures, patients 1, 2, and 3 were listed for revision at 9, 5, and 6 months, respectively, after the original procedure. All 3 underwent removal of the implant, trapeziectomy, and construction of a flexor carpi radialis tendon sling at 13, 9, and 8 months, respectively, after the original procedure. The old scar was reopened and extended into a volar approach as described by Wagner.10 The findings in each case were dense scar tissue around the implants, which were well fixed. The Artelon was found to be strongly incorporated into the host tissues, which made it difficult to remove. Furthermore, the implants had to be excised by
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FIGURE 4: Section of explanted tissue from patient 3 showing multiple foreign body–type giant cells. The arrow indicates a foreign body–type giant cell containing foreign material. (Hematoxylin-eosin stain; magnification ⫻10.) FIGURE 3: Postoperative radiograph of patient 3 at 2 months after Artelon implantation.
sharp dissection. There was no macroscopic evidence of infection in any case, although we did not obtain microbiology specimens to confirm this. Similarly, there was no macroscopic evidence of granulation tissue, inflammation, or synovitis. In both the primary and revision surgeries, the rehabilitation protocol was to allow free mobilization under the supervision of a hand therapist as soon as the patient’s plaster was removed. The therapy protocol was identical to that following the primary procedure. We did not take intraoperative microbiology samples because there was no macroscopic evidence of infection. Histological analysis of the explanted Artelon material in all 3 samples showed large numbers of foreign body–type giant cells within the soft tissues and bone closely associated with the implant (Figs. 4, 5). These giant cells contained foreign material. When viewed by polarized microscopy, this material was birefringent in appearance. Considering that this material was seen in all specimens of explanted tissue that macroscopically contained Artelon, we concluded that the foreign material was most likely Artelon or degraded Artelon material. After the Artelon material was removed and after revision trapeziectomy with a flexor carpi radialis sling, all patients reported improvement in symptoms. The mean postrevision Michigan Hand Outcomes Questionnaire was 52 (SD, 23) in the hand that underwent surgery and 73 (SD, 7) in the hand that had not. The individual scores in hands
FIGURE 5: Section of explanted tissue from patient 3 showing foreign body–type giant cells seen to contain foreign material. The arrow indicates a foreign body–type giant cell containing pale foreign material. (Hematoxylin-eosin stain; magnification ⫻40.)
that had undergone surgery and those that had not were 69 and 75 for patient 1, 61 and 80 for patient 2, and 26 and 66 for patient 3. DISCUSSION Artelon is a woven, degradable synthetic biomaterial composed from a polycaprolactone-based polyurethaneurea. The biocompatibility of this material has previously been reported in the literature in vitro and in vivo in animal models.11–13 According to the manufacturer, the device has 2 modes of action: it resurfaces the distal part of the trapezium and it augments the thumb CMC
JHS 䉬 Vol A, January
THREE CASES OF FOREIGN BODY–TYPE REACTION
joint capsule.14 An Artelon implant for use in scaphotrapeziotrapezoid joint OA is also available. The biomaterial is intended to prevent bony impingement and provide a degradable scaffold for the ingrowth of soft tissue. The degradation process takes place by hydrolysis over approximately 6 years,11,15 with 50% of the initial mass of Artelon material remaining permanently at the implant site.15 All 3 of our patients had ongoing pain in the presence of foreign body–type giant cells that were closely related to what is presumed to be Artelon material. In our opinion, it is unlikely that the postoperative pain experienced by these patients was caused by periprosthetic infection. Unfortunately we were unable to conclusively establish the absence of surgical site infection because microbiology samples were not taken. Recently, there have been 2 reported cases of foreign body reaction attributed to the Artelon CMC implant and the Artelon scaphotrapeziotrapezoid implant.5,6 In both cases, the pathological specimens contained multinucleated giant cells. Giuffrida et al.6 found that the foreign material within the multinucleated giant cells was birefringent, a finding we also noted in our 3 specimens. Choung and Tan5 did not report foreign material in their specimens. In terms of tissue integration, Giuffrida et al.6 noted a complete failure of host incorporation of the material. This was given as a possible contributing factor to the foreign body reaction. Conversely, in all of our patients the implant was found to be well integrated with the host tissue and difficult to remove. Giuffrida et al.6 used suture anchors loaded with coated polyester sutures (Ethibond) to fix the implant, whereas Choung and Tan5 used screws but did not give further details about the screw type. We used titanium screws with a washer to secure the implant to bone. Because we did not use sutures for implant fixation, there can be no question of suture material causing the foreign body reaction observed in our report. Furthermore, the biocompatibility of titanium is well documented, and therefore we must assume that the foreign body–type giant cell reaction was related to the Artelon material. An in vivo animal study using Artelon material to perform anterior cruciate ligament reconstruction in rabbit and minipig knee joints found no signs of pathology in the knee joints analyzed. When Artelon was implanted into rabbit knees by suturing to the synovial membrane, a mild foreign body response and inflammatory reaction was seen at the tissue–Artelon inter-
119
face, with normal appearances of the remaining synovial membrane.12 A study by Nilsson et al.2 reported that the Artelon implant gave major pain relief in all 10 patients and had superior results in terms of pinch strength compared with tendon arthroplasty for the treatment of thumb CMC joint OA. Furthermore, biopsies taken from 2 patients at 6 and 12 months after implantation revealed no chronic inflammatory cells or foreign body response. The results of a randomized, controlled, observer-blinded, multicenter study supported by Artimplant AB have recently been published.3 The study involved 109 patients (72 Artelon CMC spacer and 37 tendon interposition arthroplasty). A total of 12 Artelon implants were removed because of pain. Histological analysis found no signs of inflammation near the implants and there was no microbiological evidence of infection. However, the authors reported 2 cases of inflammatory cells associated with the fixation sutures. Disabilities of the Arm, Shoulder, and Hand score and visual analog score improved postoperatively in both groups at 12 months. The authors concluded that the Artelon CMC spacer did not show superior results compared with tendon interposition arthroplasty. A further study by Jörheim et al.4 compared 13 patients who had Artelon implantation with a matched cohort of 40 patients who had tendon interposition arthroplasty for thumb CMC joint OA. There was no significant difference in postoperative Quick–Disabilities of the Arm, Shoulder, and Hand score, pinch strength, grip strength, or range of movement. Two Artelon patients had revision to tendon arthroplasty 6 and 15 months after surgery because of persistent pain, and a further 2 had removal of screws owing to pain. No histological results were reported. Our 3 cases add to the existing evidence relating to the Artelon implant. Foreign body–type giant cells have been found in surgically excised Artelon implants from patients experiencing continued pain after undergoing Artelon implantation. Patients and surgeons must be made aware of the potential for foreign body–type cells and an adverse outcome after use of the implant. REFERENCES 1. Wajon A, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev 2009;4:CD004631. Available: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/ articles/CD004631/frame.html. Accessed: Apr 25, 2010.
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2. Nilsson A, Liljensten E, Bergstrom C, Sollerman C. Results from a degradable TMC joint spacer (Artelon) compared with tendon arthroplasty. J Hand Surg 2005;30A:380 –389. 3. Nilsson A, Wiig M, Alnehill H, Berggren M, Björnum S, Geijer M, et al. The Artelon CMC spacer compared with tendon interposition arthroplasty. Acta Orthop 2010;81:239 –246. 4. Jörheim M, Isaxon I, Flondell M, Kalén P, Atroshi I. Short-term outcomes of trapeziometacarpal artelon implant compared with tendon suspension interposition arthroplasty for osteoarthritis: a matched cohort study. J Hand Surg 2009;34A:1381–1387. 5. Choung EW, Tan V. Foreign-body reaction to the Artelon CMC joint spacer: case report. J Hand Surg 2008;33A:1617–1620. 6. Giuffrida AY, Gyuricza C, Perino G, Weiland AJ. Foreign body reaction to artelon spacer: case report. J Hand Surg 2009;34A:1388 – 1392. 7. Diao E. Foreign-body reaction to the Artelon CMC joint spacer. J Hand Surg 2009;34A:1158 –1159; author reply 1159 –1160. 8. Artelon CMC spacer. Product information. Available: http://www.total smallbone.com/us/pdfs/artelon/B_Artelon_Info.pdf. Accessed: Apr 25, 2010. 9. Artelon CMC spacer. Surgical procedure. Available: http://www.
10. 11.
12.
13.
14.
15.
totalsmallbone.com/us/pdfs/artelon/MKT40110RevE.pdf. Accessed: Apr 25, 2010. Wagner CJ. Method of treatment of Bennett’s fracture dislocation. Am J Surg 1950;80:230 –231. Gretzer C, Gisselfalt K, Liljensten E, Ryden L, Thomsen P. Adhesion, apoptosis and cytokine release of human mononuclear cells cultured on degradable poly(urethane urea), polystyrene and titanium in vitro. Biomaterials 2003;24:2843–2852. Liljensten E, Gisselfalt K, Edberg B, Bertilsson H, Flodin P, Nilsson A, et al. Studies of polyurethane urea bands for ACL reconstruction. J Mat Sci Mat Med 2002;13:351–359. Gretzer C, Emanuelsson L, Liljensten E, Thomsen P. The inflammatory cell influx and cytokines changes during transition from acute inflammation to fibrous repair around implanted materials. J Biomater Sci Polym Ed 2006;17:669 – 687. Artelon CMC Spacer and Artelon CMC Spacer LG. Small bone innovations inc. Available: http://www.totalsmallbone.com/us/products/ thumb/artelon_cmc.php4. Accessed: May 17, 2010. Artelon CMC spacer. Biodegradation leaflet. Available: http://www. totalsmallbone.com/us/pdfs/artelon/B_Artelon_Biodegradation.pdf. Accessed: Apr 25, 2010.
JHS 䉬 Vol A, January
Foreign Body Reaction Associated With Artelon: Report of Three Cases Paul M. Robinson, MBChB, LindsayT. Muir, MCh The Artelon carpometacarpal joint implant is a degradable interposition arthroplasty spacer intended for use in thumb carpometacarpal joint osteoarthritis. Recently there have been reported cases of foreign body reaction attributed to the Artelon implant, which raise concerns about the use of this implant. The implant’s manufacturers claim excellent biocompatibility. We report 3 cases of persistent pain after thumb carpometacarpal joint arthroplasty performed using Artelon implants. In all 3 cases that required removal of the Artelon implant and trapeziectomy to achieve subsequent symptom relief, foreign body–type reaction associated with the Artelon was seen histologically. (J Hand Surg 2011;36A:116–120. Copyright © 2011 by the American Society for Surgery of the Hand. All rights reserved.) Key words: Artelon, trapeziometacarpal joint, carpometacarpal joint, thumb, osteoarthritis.
T
O DATE, NO SINGLE surgical treatment has proved
to be universally superior in the management of carpometacarpal (CMC) joint osteoarthritis (OA).1 A variety of surgical solutions have been proposed to treat this difficult problem. The Artelon CMC implant (Artimplant AB, Gothenburg, Sweden) is a degradable interposition arthroplasty spacer intended for use in CMC joint OA. There have been 3 published trials comparing the Artelon CMC implant with tendon interposition arthroplasty for the treatment of CMC joint OA.2– 4 In these studies, several patients required revision of the implant for persistent pain, but no adverse histological reactions or infections were reported. However, recently there have been 2 reported cases of foreign body reaction attributed to the Artelon CMC implant and the Artelon scaphotrapeziotrapezoid implant,5,6 leading to debate about its use.7 The manFromtheSalfordRoyalNHSFoundationTrust,Salford,GreaterManchester,UnitedKingdom;andThe Queen Elizabeth Hospital King’s Lynn NHS Trust, King’s Lynn, Norfolk, United Kingdom. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Received for publication May 24, 2010; accepted in revised form October 1, 2010. Corresponding author: Paul M. Robinson, MBChB, care of Mr. Muir’s secretary, Department of Orthopaedics, Salford Royal Hospital NHS Foundation Trust, Stott Lane, Salford, Greater Manchester M6 8HD, UK; e-mail: [email protected]. 0363-5023/11/36A01-0021$36.00/0 doi:10.1016/j.jhsa.2010.10.001
116 䉬 © ASSH 䉬 Published by Elsevier, Inc. All rights reserved.
ufacturer claims excellent biocompatibility.8 We report 3 cases of foreign body reaction associated with the Artelon implant and the outcomes of revision trapeziectomy with a flexor carpi radialis tendon sling. CASE REPORT Between October 2006 and June 2007, 3 patients underwent implantation of the Artelon spacer. The ages and genders of patients 1, 2, and 3 were 67 (male), 67 (female), and 36 (female), respectively. All preoperative radiographs showed Eaton stage III CMC joint OA. Patient 3 had posttraumatic OA after a previous intraarticular fracture of the thumb metacarpal that had been treated by percutaneous K-wire fixation. Patients 1 and 2 had gradual onset of idiopathic OA of the thumb CMC joint. A single experienced consultant hand surgeon performed all surgeries, with strict adherence to the manufacturer’s instructions.9 A single dose of prophylactic intravenous antibiotic was given on induction of anesthesia before the limb was exsanguinated and a tourniquet was applied and inflated. The CMC joint was approached via a dorsoradial incision and the articular surface of the trapezium (approximately 2 mm) was resected. The limbs of the implant were secured to the prepared bone using a titanium screw (Stryker Leibinger, Freiburg, Germany). A titanium washer (Stryker Leibinger) was used to increase the contact area be-
THREE CASES OF FOREIGN BODY–TYPE REACTION
FIGURE 1: Radiograph of patient 1 at 6 months after Artelon implantation.
tween the screw and the outer surface of the implant limbs. The capsular flap was repaired with Vicryl sutures (Ethicon, Gargrave, England). The skin was sutured with interrupted Ethilon (Ethicon) and a plaster cast was applied. Postoperatively, the thumb was immobilized in a below-elbow plaster cast for 5 weeks. Mobilization began 5 weeks postoperatively and was supervised by a physiotherapist. The protocol consisted of active exercises for the wrist, fingers, and radioulnar joint, active exercises for the thumb (flexion, opposition, and span), and light functional activity. At 8 weeks, resisted thumb apposition and opposition using a Thera-Band (Akron, OH) was introduced. Passive exercises for the wrist were used if full range of movement had not been achieved. During Artelon implantation, the CMC joint demonstrated OA in all 3 cases. We judged the postoperative radiographs for each patient to be satisfactory, with satisfactory screw positions (Figs. 1–3). All wounds healed normally and there were no cases of wound infection.
117
FIGURE 2: Radiograph of patient 2 at 8 months after Artelon implantation.
All 3 patients continued to have painful symptoms at the thumb base and a reduced range of movement. No patient developed erythema or had signs of infection. Postoperatively, the patients all reported pain that was at least equal to their preoperative symptoms. One patient (patient 2) developed further swelling at the thumb base and an increase in pain at approximately 12 weeks after surgery. For these reasons and after failure of conservative measures, patients 1, 2, and 3 were listed for revision at 9, 5, and 6 months, respectively, after the original procedure. All 3 underwent removal of the implant, trapeziectomy, and construction of a flexor carpi radialis tendon sling at 13, 9, and 8 months, respectively, after the original procedure. The old scar was reopened and extended into a volar approach as described by Wagner.10 The findings in each case were dense scar tissue around the implants, which were well fixed. The Artelon was found to be strongly incorporated into the host tissues, which made it difficult to remove. Furthermore, the implants had to be excised by
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THREE CASES OF FOREIGN BODY–TYPE REACTION
FIGURE 4: Section of explanted tissue from patient 3 showing multiple foreign body–type giant cells. The arrow indicates a foreign body–type giant cell containing foreign material. (Hematoxylin-eosin stain; magnification ⫻10.) FIGURE 3: Postoperative radiograph of patient 3 at 2 months after Artelon implantation.
sharp dissection. There was no macroscopic evidence of infection in any case, although we did not obtain microbiology specimens to confirm this. Similarly, there was no macroscopic evidence of granulation tissue, inflammation, or synovitis. In both the primary and revision surgeries, the rehabilitation protocol was to allow free mobilization under the supervision of a hand therapist as soon as the patient’s plaster was removed. The therapy protocol was identical to that following the primary procedure. We did not take intraoperative microbiology samples because there was no macroscopic evidence of infection. Histological analysis of the explanted Artelon material in all 3 samples showed large numbers of foreign body–type giant cells within the soft tissues and bone closely associated with the implant (Figs. 4, 5). These giant cells contained foreign material. When viewed by polarized microscopy, this material was birefringent in appearance. Considering that this material was seen in all specimens of explanted tissue that macroscopically contained Artelon, we concluded that the foreign material was most likely Artelon or degraded Artelon material. After the Artelon material was removed and after revision trapeziectomy with a flexor carpi radialis sling, all patients reported improvement in symptoms. The mean postrevision Michigan Hand Outcomes Questionnaire was 52 (SD, 23) in the hand that underwent surgery and 73 (SD, 7) in the hand that had not. The individual scores in hands
FIGURE 5: Section of explanted tissue from patient 3 showing foreign body–type giant cells seen to contain foreign material. The arrow indicates a foreign body–type giant cell containing pale foreign material. (Hematoxylin-eosin stain; magnification ⫻40.)
that had undergone surgery and those that had not were 69 and 75 for patient 1, 61 and 80 for patient 2, and 26 and 66 for patient 3. DISCUSSION Artelon is a woven, degradable synthetic biomaterial composed from a polycaprolactone-based polyurethaneurea. The biocompatibility of this material has previously been reported in the literature in vitro and in vivo in animal models.11–13 According to the manufacturer, the device has 2 modes of action: it resurfaces the distal part of the trapezium and it augments the thumb CMC
JHS 䉬 Vol A, January
THREE CASES OF FOREIGN BODY–TYPE REACTION
joint capsule.14 An Artelon implant for use in scaphotrapeziotrapezoid joint OA is also available. The biomaterial is intended to prevent bony impingement and provide a degradable scaffold for the ingrowth of soft tissue. The degradation process takes place by hydrolysis over approximately 6 years,11,15 with 50% of the initial mass of Artelon material remaining permanently at the implant site.15 All 3 of our patients had ongoing pain in the presence of foreign body–type giant cells that were closely related to what is presumed to be Artelon material. In our opinion, it is unlikely that the postoperative pain experienced by these patients was caused by periprosthetic infection. Unfortunately we were unable to conclusively establish the absence of surgical site infection because microbiology samples were not taken. Recently, there have been 2 reported cases of foreign body reaction attributed to the Artelon CMC implant and the Artelon scaphotrapeziotrapezoid implant.5,6 In both cases, the pathological specimens contained multinucleated giant cells. Giuffrida et al.6 found that the foreign material within the multinucleated giant cells was birefringent, a finding we also noted in our 3 specimens. Choung and Tan5 did not report foreign material in their specimens. In terms of tissue integration, Giuffrida et al.6 noted a complete failure of host incorporation of the material. This was given as a possible contributing factor to the foreign body reaction. Conversely, in all of our patients the implant was found to be well integrated with the host tissue and difficult to remove. Giuffrida et al.6 used suture anchors loaded with coated polyester sutures (Ethibond) to fix the implant, whereas Choung and Tan5 used screws but did not give further details about the screw type. We used titanium screws with a washer to secure the implant to bone. Because we did not use sutures for implant fixation, there can be no question of suture material causing the foreign body reaction observed in our report. Furthermore, the biocompatibility of titanium is well documented, and therefore we must assume that the foreign body–type giant cell reaction was related to the Artelon material. An in vivo animal study using Artelon material to perform anterior cruciate ligament reconstruction in rabbit and minipig knee joints found no signs of pathology in the knee joints analyzed. When Artelon was implanted into rabbit knees by suturing to the synovial membrane, a mild foreign body response and inflammatory reaction was seen at the tissue–Artelon inter-
119
face, with normal appearances of the remaining synovial membrane.12 A study by Nilsson et al.2 reported that the Artelon implant gave major pain relief in all 10 patients and had superior results in terms of pinch strength compared with tendon arthroplasty for the treatment of thumb CMC joint OA. Furthermore, biopsies taken from 2 patients at 6 and 12 months after implantation revealed no chronic inflammatory cells or foreign body response. The results of a randomized, controlled, observer-blinded, multicenter study supported by Artimplant AB have recently been published.3 The study involved 109 patients (72 Artelon CMC spacer and 37 tendon interposition arthroplasty). A total of 12 Artelon implants were removed because of pain. Histological analysis found no signs of inflammation near the implants and there was no microbiological evidence of infection. However, the authors reported 2 cases of inflammatory cells associated with the fixation sutures. Disabilities of the Arm, Shoulder, and Hand score and visual analog score improved postoperatively in both groups at 12 months. The authors concluded that the Artelon CMC spacer did not show superior results compared with tendon interposition arthroplasty. A further study by Jörheim et al.4 compared 13 patients who had Artelon implantation with a matched cohort of 40 patients who had tendon interposition arthroplasty for thumb CMC joint OA. There was no significant difference in postoperative Quick–Disabilities of the Arm, Shoulder, and Hand score, pinch strength, grip strength, or range of movement. Two Artelon patients had revision to tendon arthroplasty 6 and 15 months after surgery because of persistent pain, and a further 2 had removal of screws owing to pain. No histological results were reported. Our 3 cases add to the existing evidence relating to the Artelon implant. Foreign body–type giant cells have been found in surgically excised Artelon implants from patients experiencing continued pain after undergoing Artelon implantation. Patients and surgeons must be made aware of the potential for foreign body–type cells and an adverse outcome after use of the implant. REFERENCES 1. Wajon A, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev 2009;4:CD004631. Available: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/ articles/CD004631/frame.html. Accessed: Apr 25, 2010.
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THREE CASES OF FOREIGN BODY–TYPE REACTION
2. Nilsson A, Liljensten E, Bergstrom C, Sollerman C. Results from a degradable TMC joint spacer (Artelon) compared with tendon arthroplasty. J Hand Surg 2005;30A:380 –389. 3. Nilsson A, Wiig M, Alnehill H, Berggren M, Björnum S, Geijer M, et al. The Artelon CMC spacer compared with tendon interposition arthroplasty. Acta Orthop 2010;81:239 –246. 4. Jörheim M, Isaxon I, Flondell M, Kalén P, Atroshi I. Short-term outcomes of trapeziometacarpal artelon implant compared with tendon suspension interposition arthroplasty for osteoarthritis: a matched cohort study. J Hand Surg 2009;34A:1381–1387. 5. Choung EW, Tan V. Foreign-body reaction to the Artelon CMC joint spacer: case report. J Hand Surg 2008;33A:1617–1620. 6. Giuffrida AY, Gyuricza C, Perino G, Weiland AJ. Foreign body reaction to artelon spacer: case report. J Hand Surg 2009;34A:1388 – 1392. 7. Diao E. Foreign-body reaction to the Artelon CMC joint spacer. J Hand Surg 2009;34A:1158 –1159; author reply 1159 –1160. 8. Artelon CMC spacer. Product information. Available: http://www.total smallbone.com/us/pdfs/artelon/B_Artelon_Info.pdf. Accessed: Apr 25, 2010. 9. Artelon CMC spacer. Surgical procedure. Available: http://www.
10. 11.
12.
13.
14.
15.
totalsmallbone.com/us/pdfs/artelon/MKT40110RevE.pdf. Accessed: Apr 25, 2010. Wagner CJ. Method of treatment of Bennett’s fracture dislocation. Am J Surg 1950;80:230 –231. Gretzer C, Gisselfalt K, Liljensten E, Ryden L, Thomsen P. Adhesion, apoptosis and cytokine release of human mononuclear cells cultured on degradable poly(urethane urea), polystyrene and titanium in vitro. Biomaterials 2003;24:2843–2852. Liljensten E, Gisselfalt K, Edberg B, Bertilsson H, Flodin P, Nilsson A, et al. Studies of polyurethane urea bands for ACL reconstruction. J Mat Sci Mat Med 2002;13:351–359. Gretzer C, Emanuelsson L, Liljensten E, Thomsen P. The inflammatory cell influx and cytokines changes during transition from acute inflammation to fibrous repair around implanted materials. J Biomater Sci Polym Ed 2006;17:669 – 687. Artelon CMC Spacer and Artelon CMC Spacer LG. Small bone innovations inc. Available: http://www.totalsmallbone.com/us/products/ thumb/artelon_cmc.php4. Accessed: May 17, 2010. Artelon CMC spacer. Biodegradation leaflet. Available: http://www. totalsmallbone.com/us/pdfs/artelon/B_Artelon_Biodegradation.pdf. Accessed: Apr 25, 2010.
JHS 䉬 Vol A, January