Clinical Device-Related Article Osteotomy of Distal Radius Fracture Malunion Using a Fast Remodeling Bone Substitute Consisting of Calcium Sulphate and Calcium Phosphate Antonio Abramo,1 Mats Geijer,2 Philippe Kopylov,1 Magnus Tägil1 1 Department of Orthopaedics, Hand Unit, Clinical Sciences, Lund University, Lund S-221 85, Sweden 2 Department of Radiology, Lund University Hospital, Lund S-221 85, Sweden Received 2 May 2008; revised 29 May 2009; accepted 16 June 2009 Published online 10 November 2009 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.b.31524 Abstract: Malunion after a distal radius fracture can be treated with an osteotomy of the distal radius. Autologous iliac crest bone graft is often used to fill the gap, but the procedure is associated with donor site morbidity. In this study a novel fast resorbing biphasic bone substitute consisting of a mixture of calcium sulphate and calcium phosphate is used (CeramentTM BoneSupport AB, Sweden). Fifteen consecutive patients, with a mean age of 52 (27–71) years were included. All had a malunion after a distal radius fracture and underwent an osteotomy. A fragment specific fixation system, TriMed1 (TriMed, Valencia, CA), consisting of a Buttress Pin1 and a Radial Pin Plate1 were used for fixation and a calcium sulphate and calcium phosphate mixture as bone substitute. The patients were followed for 1 year. Grip strength increased from 61 (28–93)% of the contralateral hand to 85 (58–109)%, p < 0.001. DASH scores decreased from 37 (22–61) to 24 (2–49) p 5 0.003. Radiographically all osteotomies healed. An increase of ulnar variance was noted during healing from 1.8 mm immediately postoperatively to 2.6 mm at final follow up. Osteotomy can increase grip strength and decease disability after a malunited fracture. In the present series the bone substitute was replaced by bone, but a minor loss of the achieved radiographic correction was noted in some patients during osteotomy healing. A more rigid fixation may improve the radiographic outcome with this kind of bone substitute. ' 2009 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 92B: 281–286, 2010 Keywords: calcium sulphate; calcium phosphate; osteotomy; distal radius; bone substitute INTRODUCTION Malunion after a distal radius fracture is a major cause for residual symptoms. It appears in about 5% of the fractures1 and the patients may suffer from decreased grip strength, poor hand and arm function and poor cosmetic appearance. To correct the deformity and relieve the symptoms, an osteotomy can be performed.2–4 The malunited fracture is cut at the fracture site and the length and/or angle is corrected using an opening wedge technique. An iliac crest bone graft is most often used to fill the gap, either as a structural single block of cortico-cancellous bone or as a nonstructural cancellous graft.5 A high incidence of donor site morbidity has been Correspondence to: A. Abramo (e-mail: [email protected]) Contract grant sponsor: Region Skåne, Lund University Hospital Contract grant sponsor: Swedish Research Council-Medicine; contract grant number: 090509 Contract grant sponsors: Stiftelsen för bistånd åt rörelsehindrade i Skåne, Alfred Österlund, Greta and Johan Kock, Crafoord and Maggie Stephens foundations, Faculty of Medicine Lund University ' 2009 Wiley Periodicals, Inc. reported,6 most commonly in the form of pain but also as wound infection or even fracture of the iliac crest. To avoid donor site morbidity, a bone substitute can be used instead of bone graft. Fast resorbing calcium sulphate has been used, and although being highly biocompatible,7 the resorption rate has been too rapid to be used in fracture treatment. Without rigid fixation, the risk of mechanical failure during the remodeling is obvious but at the same time a rigid fixation decreases the bone formation stimulus.8 Instead a nonresorbable bone substitute, such as calcium phosphate paste can be used. The injectable bone substitute is deposited into the fracture or osteotomy and sets in situ to carbonated hydroxyapatite (HA), which retains its mechanical properties during healing. HA has been used both in surgery of distal radial fractures9 and in osteotomies of malunited distal radial fractures.10–12 However, it takes years,13 if ever, to resorb and ideally a bone substitute should be resorbed within reasonable time but still maintain the strength until bone has formed. In the present study a novel injectable bone mixture containing 281 282 ABRAMO ET AL. both a calcium sulphate, resorbing during 6–12 weeks and a nonresorbing HA will combine the two resorption extremes with the hypothesis that the HA will provide structural support during the remodeling and the calcium sulphate will be remodeled swiftly into bone. The aim of this study was to evaluate the feasibility of using the calcium sulphate/calcium phosphate substitute as gap filler in distal radius osteotomies in combination with the fragment specific fixation technique, which has previously been used as fixation in combination with a nonresorbing HA.11 MATERIALS AND METHODS Fifteen patients were included prospectively as a feasibility study of a biphasic bone substitute. The study was approved by the regional research ethics committee and the Swedish Medical Products Agency. Patient Selection Inclusion criterias for this study were a malunited distal radius fracture, healed with a dorsal or volar angulation and/ or shortening and with a clinically manifesting symptom such as pain at rest, pain at activity or decreased range of motion. Patients were enrolled from two hospitals in the southern region of Sweden. Between October 2005 and November 2006, 15 consecutive patients with a malunion after a distal radial fracture underwent an osteotomy using the fragment specific system for fixation and the biphasic bone substitute as gap filler. The mean age in the study group was 52 (27–71) years; four patients were men and 11 women. Eight patients were operated on their left wrist and seven on their right. Eight were operated on their dominant wrist. The mean ulnar variance was plus 2.4 mm (0–9.2), the mean dorsal angulation was 17.98 (29.4 to 38.2) and the mean radial inclination was 19.28 (8.8–30.2). All the patients had had their fractures treated by closed reduction and fixation in a below elbow cast as primary fracture treatment. Presurgical Preparation Blood samples were collected preoperatively and at each follow up, analyzing the platelet count, thyroid hormone, thyroid stimulating hormone, calcium and CRP to monitor any potential side effect of the dissolving bone substitute. Preoperative radiographs including a lateral and an anterior–posterior view were taken A clinical examination was performed with measuring of the grip strength and preoperative pain level and patients filled out a preoperative DASH-from. Surgical Protocol All operations were performed by two surgeons (A.A. and P.K.). The technique has been described previously but Figure 1. AP and lateral radiographs of a patient operated with a distal radius osteotomy using Radial Pin Plate1, Pins, Buttress Pin1 and screws. The bone substitute is used to fill the gap. with the use of Norian SRS1, a single phase substitute consisting of a HA (dahlite), as a bone substitute instead of this novel biphasic CS/HA material.11 In all osteotomies the fragment specific fixation system was used for fixation and the the biphasic bone substitute as gap filler. The fixation system is a fragment specific fixation device for distal radial fractures consisting of plates and pins. In the osteotomy technique in the present study a Radial Pin Plate1 and a dorsal Buttress Pin1 were inserted using two separate incisions. A dorsal incision was made through the fourth compartment to perform the osteotomy and to introduce the Buttress Pin1 and the bone substitute (Figure 1). A second radio-volar incision was centered over the styloid and the first extensor tendon compartment to allow for placement of the radial pins and the Radial Pin Plate1. Once a correct level for the osteotomy was established, the radius was cut with an oscillating saw, leaving the periosteum intact at the volar side. The dorsal and radial malalignment were corrected. The osteotomy was temporarily secured by the Buttress Pin1, which could be slid to correct the axial deformity. The Buttress Pin1 screw was tightened, the radial pins inserted and the correction controlled in the fluoroscope. Before injecting the bone substitute, the Radial Pin Plate1 was applied to secure full stability. Postoperatively the wrist was immobilized in a plaster cast for 2 weeks and thereafter active mobilization was encouraged in a removable soft splint. Bone Substitute A novel bone substitute has been developed allowing new bone tissue to grow into the bone defect made possible by certain porosity.14 It is an injectable bone substitute and consists of 60% calcium sulphate (CS) and 40% HA.15 Journal of Biomedical Materials Research Part B: Applied Biomaterials OSTEOTOMY WITH A CALCIUM SULPHATE/CALCIUM PHOSPHATE BONE SUBSTITUTE This ratio gives the mixture a compressive strength of 35– 50 MPa comparable to trabecular bone and a better strength than with a 50/50 ratio of CS and HA.16 Both the CS and the HA are synthetically made to control quality and purity of the mineral phases. The HA is of medical grade and tested according to American standard, ASTM F1185. The HA particles are small (\100 lm) and high temperature sintered to give a round shape and smooth surface for optimal handling characteristics. The bone substitute powder is mixed with OmnipaqueTM (GE HealthCare) a low osmolar, nonionic, iodinated contrast agent (iohexol), to form an injectable paste. The working time and injectability of the substance is 7 minutes using a 16G cannula and the final setting time is 25 minutes. The setting temperature is 39 centigrade. Follow-up Clinical follow ups were performed at 2 weeks, 7 weeks, 3 months and at 1 year. These follow ups include clinical examination, blood samples, radiographic examination and the DASH form. The subjective and objective outcomes were followed prospectively to monitor the clinical improvement by the operation per se. Radiographs Radiographs were obtained preoperatively, postoperatively and at every follow-up to monitor the mechanical integrity of the bone substitute during remodeling. A radiologist (M.G.) measured all radiographs. Radial shortening was measured as ulnar variance from the distal radial surface to the distal ulnar surface according to the method of perpendiculars on AP radiographs of the wrist obtained in the neutral position. The radial inclination angle was measured on the AP radiographs and the dorsal angulation on the lateral view, expressed as the angle of joint surface relative to the radial length axis.17 The resorption of bone substitute was evaluated in the radiographs, by estimating the amount of remaining radio-opaque material in the gap. The degree of radiographic healing of the osteotomy was also appreciated in no healing, partial healing and definite healing. 283 general use in upper extremity disorders but not specifically for distal radius fractures.19 The questionnaire consists of 30 questions evaluating physical activities, symptom severity and the effect of the injury on social activities. A score is calculated and the disability of the patient is estimated on a scale from 0 to 100, with 100 being the worst result that is reflecting the highest degree of disability. At study entry, the mean pain as measured on a visual analogue scale (0–10 cm) was 5.5 (3–10) and the mean DASH score was 37 (22–61). Statistics Student’s paired t-test was used to compare pre- and postoperative data as well as to evaluate radiographic changes within the first year. Repeated measures ANOVA was used for repeated measures within the group and Wilcoxon’s rank sum test to compare pre- and postoperative DASH and pain scores. The SPSS program (SPSS, Chicago, IL) version 14.0 was used for the statistical analyses. RESULTS All patients were admitted as outpatients. Eleven of the 15 patients could return home the same day and the others the morning after. One patient had the pins and plate removed at 8 months postoperatively due to pain from the Radial Pin Plate1. The osteotomy was healed at that time. There were no adverse events correlated to the bone substitute at follow up, neither by clinical examination nor in the blood samples. There were seven adverse events correlated to the surgery or to the fixation device. One patient had a rupture of the extensor pollicis longus tendon (EPL) treated by an extensor indices proprius tendon (EIP) transfer. One patient had a carpal tunnel syndrome treated by carpal tunnel release. One patient had a postoperative wound infection which was treated successfully with antibiotics and healed uneventfully. Three patients had local pain and tenderness due to the Radial Pin Plate1, in one patient due to a pin which had to be removed and in two patients due to a transient irritation of the tendons in the first dorsal compartment and the radial nerve branches. Objective Tests Grip strength was measured using a dynamometer (Jamar; Preston Corp, Jackson, MI). The mean preoperative grip strength was 61% (28–93%) of the contralateral, uninjured side. The patients rated their pain at activity and at rest on a 10 cm visual analog scale (VAS) and the functional outcome was evaluated using the Swedish version of the validated outcome score disability of the arm, shoulder and hand (DASH). DASH is a self-administered questionnaire developed by the AAOS and the Institute for Work and Health in Canada.18 The Swedish version was validated for Journal of Biomedical Materials Research Part B: Applied Biomaterials The mean operation time was 75 (58–91) minutes. Grip strength increased from 61% (28–93%) of the uninjured side preoperatively to 85% (58–109%, p \ 0.001) at 1 year (Figure 2). Subjective The preoperative pain at rest as measured on a visual analogue scale (0–10 cm) vas 5.5 (3–10) and decreased to 2.4 (1–6) at 1 year (p \ 0.001). The mean DASH score was 37 (22–61) preoperatively and improved to 24 (2–53) already at 3 months postoperatively (p 5 0.011). The score 284 ABRAMO ET AL. operatively and 22.28 (219.3 to 17, p 5 0.001) at the final follow up (Figure 4, Table I). In three patients, there was a more than 1 mm loss of ulnar variance correction from immediately postoperatively (mean 4.6 mm, range 2.8 to 7.8 mm) to the 1 year follow-up (mean 6.4 mm, range 4.6– 9.4 mm). One additional patient who had one of the radial Figure 2. Mean grip strength expressed as a percentage of the contralateral wrist; preoperatively and at follow up. Error bars represent 95% confidence interval. improved further and was 20 (2–49) at 1 year (p 5 0.003) (Figure 3). Radiology Radiographically, all the osteotomies healed. One patient fell due to a minor cerebral infarction, traumatized her wrist and the pins broke with a loss of correction. As expected a high rate of early decrease in radiolucent material in the gap was noted. The mean ulnar variance for the whole group was 12.4 mm (0–9.2) preoperatively, 11.9 mm (21.0 to 7.8 mm) immediately postoperatively and 12.6 mm (20.6 to 9.4 mm) at the final follow up. These changes were statistically not significant. The mean radial inclination was 19.38 (8.8–30.2) preoperatively, 22.98 (14.9–30.8) postoperatively and 24.38 (18.0–32.6 p 5 0.002) at 1 year. The mean dorsal angulation was 17.9 (29.4 to 38.2) preoperatively, 21.18 (215.0 to 12.2) post- Figure 3. DASH score and VAS pain (cm) at rest, preoperatively and at follow up. Error bars represent the 95% confidence interval. Figure 4. Radiographic appearance at follow up. An improvement is seen in dorsal angulation and radial inclination but there is no significant change in ulnar variance. Error bars represent 95% confidence interval. Journal of Biomedical Materials Research Part B: Applied Biomaterials OSTEOTOMY WITH A CALCIUM SULPHATE/CALCIUM PHOSPHATE BONE SUBSTITUTE TABLE I. Radiographic Results Mean (range) Ulnar variance Preop Postop 2 week 7 week 3 month 1 year Radial inclination Preop Postop 2 week 7 week 3 month 1 year Dorsal angulation Preop Postop 2 week 7 week 3 month 1 year 2.4 1.9 2 2.4 2.8 2.6 19.3 22.9 23.8 24.4 24 24.3 17.9 21.1 23 23 23.9 22.2 (0–9.2) (21 to 7.8) (21.6 to 8.6) (21.2 to 9.2) (21.4 to 10) (20.6 to 9.4) (8.8–30.2) (14.9–30.8) (19.4–35) (16.9–32.5) (18.9–32.6) (18–32.6) (29.4 to 38.2) (215 to 12.2) (217.8 to 13.7) (219.9 to 19.7) (219.7 to 19.3) (219.3 to 18.2) a SD p-Value 2.4 2.3 2.5 2.7 2.8 2.4 5.1 4.5 5.1 4.6 4.0 4.4 12.9 8.7 9.0 11.7 13.0 9.9 1 0.9 1 1 1 0.2 0.001 \0.001 0.004 0.002 0.001 \0.001 \0.001 \0.001 0.001 a p-value compared to preoperative values. Repeated measures ANOVA with Bonferroni correction. pins removed due to spontaneous retraction underwent an ulnar shortening osteotomy at 8 months after the osteotomy because of persisting pain and poor range of motion and a radiographic shortening of the radius. DISCUSSION Bone substitutes are used to avoid donor site problems associated with the harvest of iliac crest bone graft. The efficacy of both the operation per se and the use of bone substitute have been shown in previous studies. Most often an unresorbable HA is used in combination with K-wires in a closed fashion,10 in combination with an open but minimal invasive fixation technique as described in the present study,11 or as a full open technique using a volar fixed angle plate.12 Using bone substitute, osteotomy of the distal radius can be performed as an outpatient procedure. The choice of which bone substitute to use is of importance in relation to the choice of fixation method. A pure hydroxyl apatite bone substitute takes a long time to resorb, if ever, and the surrounding healing bone at best incorporates and bridges the void filler. Ideally, a faster resorbing gap filler would allow for quick remodeling of the bone substitute into bone to normalize mechanical integrity. In this study we combined the slow-resorbing calcium-phosphate (HA) providing structure during remodeling with a faster resorbing, or dissolving, calcium sulphate which can be replaced by bone. Previous reports on composite graft of this kind consisting of 40% CS and 60% HA have shown promising results especially when combined with osteoinductive factors. 20 The mixture of a solid and a soluble phase of the bone substitute allow manipulation of the bone healing and Journal of Biomedical Materials Research Part B: Applied Biomaterials 285 remodeling. Drugs can be added to the soluble phase to be released during the four first weeks. Besides antibiotics, theoretically a bone morphogenic protein (BMP) or another osteoinductive peptide can be added to increase bone formation. A further advantage might be that the elasticity modulus of the biphasic bone substitute (0.3–0.4 GPa) is equivalent to cancellous bone and will decrease the shear forces at the bone substitute to bone interface. HA has a higher modulus and with a stiffer material, stress shielding of the bone surrounding the bone substitute might lead to resorption. As Demonstrated in this Study, the Reduction can be Lost in Some Patients During the Remodeling With a fast resorption of the bone substitute, such as with the present bone void filler, the fixation becomes more important and more rigid solutions are necessary. Without being bulky, the Fragment specific fixation system is more rigid than pins alone and the same fixation strength is reached as with a volar angle stable plate, at least in cadaver studies.21 In vivo, when diverging muscle forces are added as in the present study, the fixation in some cases does not seem to be rigid enough. Although the dorsal angulation was unaffected, axial compression occurred during the remodeling in four patients. A delicate balance thus exists between on one hand the wish to speed up the remodeling, but at the same time without losing the mechanical integrity during the remodeling. The objective results in the present study regarding increased grip strength and pain relief are good and equivalent to previous studies in osteotomies of the distal radius using bone grafts.2,22,23 In the present series grip strength increased to 85% of the uninjured side which is better or comparable to other studies with plating and a conventional bone graft5,22 or a bone substitute.10–12 Also subjectively, a substantial improvement was recorded using the DASH outcome score. DASH decreased from 37 preoperatively to 20 at the final follow up. The results all implicate that the operation offers a substantial improvement of the symptoms but no normalization. A faster resorbing bone substitute like this biphasic CS/HA substitute can be used as a safe alternative to bone graft. Still 4 of 15 patients lost some radial length during the remodeling period and although no correlation was found between radiographical and subjective outcome in the present study, it has previously been shown to influence the outcome.24 In the authors’ opinion a careful choice of fixation is recommended with the relatively fast resorption of the calcium sulphate component of the biphasic bone substitute and more rigid fixation may be necessary. This might be obtained by adding an Ulnar Pin Plate or by a complete change of fixation device to a volar fixed angle plate to prevent the loss of reduction. The authors thank research nurse Marlene Andersson for excellent assistance and PhD Malin Nilsson for valuable advice. The 286 ABRAMO ET AL. project was monitored by BoneSupport AB, Lund, Sweden who supplied the Cerament. REFERENCES 1. Cooney WP, III, Dobyns JH, Linscheid RL. Complications of Colles’ fractures. J Bone Joint Surg Am 1980;62:613–619. 2. Fernandez DL. Correction of post-traumatic wrist deformity in adults by osteotomy, bone-grafting, and internal fixation. J Bone Joint Surg Am 1982;64:1164–1178. 3. Prommersberger KJ, Van Schoonhoven J, Lanz UB. Outcome after corrective osteotomy for malunited fractures of the distal end of the radius. J Hand Surg [Br] 2002;27:55–60. 4. Van Cauwelaert de Wyels J, De Smet L. Corrective osteotomy for malunion of the distal radius in young and middle-aged patients: An outcome study. Chir Main 2003;22:84–89. 5. Ring D, Roberge C, Morgan T, Jupiter JB. Osteotomy for malunited fractures of the distal radius: A comparison of structural and nonstructural autogenous bone grafts. J Hand Surg [Am] 2002;27:216–222. 6. Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res 1996;329:300–309. 7. Peltier LF. The use of plaster of Paris to fill defects in bone. Clin Orthop 1961;21:1–31. 8. Laftman P, Sigurdsson F, Stromberg L. Recovery of diaphyseal bone strength after rigid internal plate fixation. An experimental study in the rabbit. Acta Orthop Scand 1980;51:215– 222. 9. Kopylov P. Injectable calcium phosphate bone substitute in distal radial fractures, PhD thesis. Lund: Lund University; 2001. 10. Luchetti R. Corrective osteotomy of malunited distal radius fractures using carbonated hydroxyapatite as an alternative to autogenous bone grafting. J Hand Surg [Am] 2004;29:825– 834. 11. Abramo A, Tägil M, Geijer M, Kopylov P. Osteotomy of dorsally displaced malunited fractures of the distal radius. No loss of radiographic correction during healing with a minimal invasive fixation technique and an injectable bone substitute Acta Orthop 2008;79:262–268. 12. Lozano-Calderon S, Moore M, Liebman M, Jupiter JB. Distal radius osteotomy in the elderly patient using angular stable implants and Norian bone cement. J Hand Surg [Am] 2007; 32:976–983. 13. Manzotti A, Confalonieri N, Pullen C. Grafting of tibial bone defects in knee replacement using Norian skeletal repair system. Arch Orthop Trauma Surg 2006;126:594–598. 14. Nilsson M, Fernandez E, Sarda S, Lidgren L, Planell JA. Characterization of a novel calcium phosphate/sulphate bone cement. J Biomed Mater Res 2002;61:600–607. 15. Nilsson M, Wang JS, Wielanek L, Tanner KE, Lidgren L. Biodegradation and biocompatability of a calcium sulphatehydroxyapatite bone substitute. J Bone Joint Surg Br 2004;86: 120–125. 16. Nilsson M, Wielanek L, Wang JS, Tanner KE, Lidgren L. Factors influencing the compressive strength of an injectable calcium sulfate-hydroxyapatite cement. J Mater Sci Mater Med 2003;14:399–404. 17. Mann FA, Wilson AJ, Gilula LA. Radiographic evaluation of the wrist: What does the hand surgeon want to know? Radiology 1992;184:15–24. 18. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 1996;29:602– 608. 19. Atroshi I, Gummesson C, Andersson B, Dahlgren E, Johansson A. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: Reliability and validity of the Swedish version evaluated in 176 patients. Acta Orthop Scand 2000; 71:613–618. 20. Damien CJ, Parsons JR, Benedict JJ, Weisman DS. Investigation of a hydroxyapatite and calcium sulfate composite supplemented with an osteoinductive factor. J Biomed Mater Res 1990;24:639–654. 21. Taylor KF, Parks BG, Segalman KA. Biomechanical stability of a fixed-angle volar plate versus fragment-specific fixation system: Cyclic testing in a c2-type distal radius cadaver fracture model. J Hand Surg [Am] 2006;31:373–381. 22. Jupiter JB, Ring D. A comparison of early and late reconstruction of malunited fractures of the distal end of the radius. J Bone Joint Surg Am 1996;78:739–748. 23. Flinkkilä T, Raatikainen T, Kaarela O, Hämäläinen M. Corrective osteotomy for malunion of the distal radius. Arch Orthop Trauma Surg 2000;120:23–26. 24. McQueen MM, Hajducka C, Court-Brown CM. Redisplaced unstable fractures of the distal radius: A prospective randomised comparison of four methods of treatment. J Bone Joint Surg Br 1996;78:404–409. Journal of Biomedical Materials Research Part B: Applied Biomaterials
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