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Arch Orthop Trauma Surg (2009) 129:373–379 DOI 10.1007/s00402-008-0689-4 ARTHROSCOPY AND SPORTS MEDICINE Suture anchor Wxation strength in osteopenic versus non-osteopenic bone for rotator cuV repair Matthias F. Pietschmann · Valerie Fröhlich · Andreas Ficklscherer · Mehmet F. Gülecyüz · Bernd Wegener · Volkmar Jansson · Peter E. Müller Received: 11 January 2008 / Accepted: 17 June 2008 / Published online: 8 July 2008 © Springer-Verlag 2008 Abstract Introduction Rotator cuV tears are increasing with age. Does osteopenic bone have an inXuence on the pullout strength of suture anchors? Materials and methods SPIRALOK 5.0 mm (DePuy Mitek), Super Revo 5 mm and UltraSorb (both ConMed Linvatec) suture anchors were tested in six osteopenic and six healthy human cadaveric humeri. Incremental cyclic loading was performed. The ultimate failure load, anchor displacement, and the mode of failure were recorded. Results In the non-osteopenic bone group, the absorbable SPIRALOK 5.0 mm achieved a signiWcantly better pullout strength (274 N § 29 N, mean § SD) than the titanium anchor Super Revo 5 mm (188 N § 34 N, mean § SD), and the tilting anchor UltraSorb (192 N § 34 N, mean § SD). In the osteopenic bone group no signiWcant diVerence in the pullout strength was found. The failure mechanisms, such as anchor pullout, rupture at eyelet, suture breakage and breakage of eyelet, varied between the anchors. Conclusion The present study demonstrates that, in oste- openic bone, absorbable suture anchors do not have lower pullout strengths than metal anchors. In normal bone, the bioabsorbable anchor in this study even outperformed the non-absorbable anchor. Keywords Shoulder · Rotator cuV tear · Suture anchor · Bone density Introduction Rotator cuV tears are more common among the elderly pop- ulation [19–21], thus the rotator cuV tear is often associated with osteoporotic or osteopenic bone in the proximal humerus, in particular with female patients [21], therefore making higher demands on the anchoring system was used. Metal anchors are still favored in rotator cuV surgery, especially in osteopenic bones, since they are easy to han- dle, inexpensive, and according to some surgeons, possess higher pullout strength. However, metal anchors interfere with radiographic diagnostic procedures and cause prob- lems in revision procedures [8]. In contrast, absorbable suture anchors represent an alternative solution. They bear the advantage of becoming absorbed after a certain time thereby minimizing complications generated by migration, and give less scatter on radiographic diagnostic procedure than metal anchors. The purpose of this study was to compare a newer absorb- able anchor particularly developed for osteopenic bone, SPIRALOK suture anchor (5.0 mm, DePuy Mitek, Raynham, MA, USA), with established suture anchors. For comparison, we chose the Super Revo 5 mm titanium suture anchor (ConMed Linvatec, Utica, NY, USA), and the absorbable UltraSorb tilting anchor (Linvatec, Largo, FL, USA) for the repair of rotator cuV tears in healthy and osteopenic bone. Materials and methods Specimen preparation Twelve human humeri from 12 cadavers, eight male and four female bones, with a mean age of 57 years at the time of death (range 27–93 years) were used (Fig. 1). M. F. Pietschmann · V. Fröhlich · A. Ficklscherer · M. F. Gülecyüz · B. Wegener · V. Jansson · P. E. Müller (&) Department of Orthopedics, Klinikum Grosshadern, Ludwig-Maximilians-Universitaet Munich, Marchioninistr. 15, 81377 Munich, Germany e-mail: peter.mueller@med.uni-muenchen.de; mpietschmann@yahoo.com 123 374 Arch Orthop Trauma Surg (2009) 129:373–379 The specimens were taken within 24 h, post mortem. The soft-tissue was removed, freeing the humeral head. Prerequisite for inclusion into the study was a macroscopi- cally intact humeral head. Evidence of surgical intervention or other pathologic conditions, such as prior fracture, were taken as exclusion criteria. Measurement of bone density The exact bone mineral density (BMD) of the humeri was measured by a bone density scan using a 64-slice-computed tomography system (Siemens, Sensation 64 Somatom, Munich, Germany). Five measurements with a layer thick- ness of 3 mm each were accomplished in the proximal range of the humeral head. Analysis was carried out with the use of Osteo software (Siemens, Munich, Germany). The program was originally used to quantify bone density in the lumbar spine and was adapted for the humeral head. Trabecular and cortical BMD of the humeral head were deWned [21]. Depending on the BMD the human humeri were divided into two groups, non-osteopenic and osteopenic. Until testing, the specimens were stored frozen at ¡21°C. The humeri were thawed carefully at 4°C over a period of 24 h before measurement, and kept moist during the test with 0.9% NaCl. The measurements were per- formed at room temperature. Suture anchors Two screw anchors and one tilting anchor were tested (Fig. 2): • SPIRALOK 5.0 mm (DePuy Mitek, Raynham, MA, USA): absorbable suture anchor, screw anchor made from poly-L-lactic acid with Ethibond-polyamide- sutures (USP 2) • Super Revo 5 mm (ConMed Linvatec, Utica, NY, USA): titanium suture anchor, screw anchor with coated non- absorbable twisted polyester sutures (USP 2) • UltraSorb anchor (ConMed Linvatec, Utica, NY, USA): absorbable suture anchor, PLA, tilting anchor with silicone-coated, non-absorbable twisted polyester sutures (USP 2) For the sake of comparability and to focus on the diVer- ences in anchor design, both screw type anchors had a diameter of 5 mm in both the osteopenic and healthy bone groups, even though anchors with a greater diameter such as 6.5 mm might yield better results in osteopenic bone. Placing the suture anchors • Three suture anchors were placed along the lateral ridge of the greater tuberosity at intervals of approxi- mately 10 mm as described by Meier et al. for single row suture anchor repair technique [15]. Consequently, there were three implantation sites: an anterior, a medial and a posterior one (Fig. 3a). The anchor posi- tions were regularly alternated in order to minimize the inXuence of possible variations in bone density at the various positions [1, 7, 18]. The diVerent suture anchors were inserted according to the manufacturers’ instructions at a 45° angle to the diaphysis of the humerus [5, 7, 21] (Fig. 3b). The anchors were tested with the suture material supplied by the manufacturer. Biomechanics An electromechanical testing machine (model Z010/TN2A; Zwick, Ulm, Germany) with a measuring range from 20 N to 10 kN and an uncertainty measurement of 0.21% was Fig. 1 Age distribution of the twelve cadaver specimen in this study 0 1 2 3 4 age nu m be r of s pe ci m en 91-10081-9071-8061-7051-6041-5031-4021-30 Fig. 2 Types of suture anchors tested in this study from left to right: UltraSorb, Linvatec. Super Revo 5 mm, Linvatec. SPIRALOK 5.0 mm, DePuy Mitek 123 Arch Orthop Trauma Surg (2009) 129:373–379 375 used. The data evaluation was recorded with testXpert V5.0 (Zwick, Ulm, Germany). The humeri were Wxed to a custom made mounting- plate. The direction of pull was at 135° to the axis of the humeral shaft. This set-up replicates the physiologic pull of the supraspinatus tendon [18]. One anchor of each type was tested individually. The anchor sutures were Wxed between two clamping jaws of the testing machine. The distance between implan- tation site and clamping jaws was 30 mm. Cyclic loading was performed to simulate clinical condi- tions [6, 7, 18]. As described in Biomechanics, a preload of 20 N and a crosshead extension rate of 20 mm/min were selected [18]. Fifty cycles with a tensile load of 75 N were applied, and then the tensile load was increased to 100 N for another 50 cycles. Until failure of the anchor Wxation system (suture breakage, anchor pullout, etc.), the tensile load was gradually increased by 25 N per 50 cycles [18]. The ultimate failure loads, the total systemdisplacement, as well as the system displacement after the Wrst pull with 75 N were recorded during testing. As displacement, we deWned anchor dislocation and irreversible suture lengthening. Additionally, the respective modes of failure were documented. Statistical analysis The statistical analysis was performed with the use of GraphPad Prism statistical software, version 3.02 (Graph- Pad Software, San Diego, CA, USA). The analysis of the BMD was performed with the Mann–Whitney-U-test. For testing the signiWcance of all three anchor Wxation systems, the Kruskal–Wallis test for multiple samples was used. Finally, using the Dunn’s post hoc test, the experimental groups were compared individually. All three tests are non- parametric tests for unpaired samples. The signiWcances were calculated on the basis of a 5% level (p 0.05). Modes of failure Modes of failure varied depending on BMD and anchor design. Suture break at the eyelet occurred with the Super Revo titanium anchor whereas, the SPIRALOK and Ultra- Sorb anchors displayed suture breaks in places other than the eyelet. In the osteopenic group, the number of anchor pullouts clearly increased (Tables 1 and 2). Ultimate failure load The ultimate failure loads of each individual anchor Wxa- tion system ranged from a mean of 151 N (UltraSorb, oste- openic bone) to a mean of 274 N (SPIRALOK 5.0 mm, non-osteopenic bone). In 12 humeri, the SPIRALOK achieved the highest pullout strengh with 222 N (§59 N SD), compared to the Super Revo with 169 N (§41 N SD) and the UltraSorb with 171 N (§41 N SD). There was a signiWcant diVerence in the pullout strength of the SPIRALOK 5.0 mm in non-osteopenic and osteope- nic bone (p 0.05) (Tables 1 and 2). The statistical comparison of the pullout strength of the diVerent anchors did not show a signiWcant diVerence within the osteopenic bone group. The comparison of the anchors in the non-osteopenic humeri showed signiWcantly higher pullout strength of the SPIRALOK anchor compared to the Super Revo 5 mm, and to the UltraSorb tilting anchor (p 0.05). Discussion The ideal suture anchor should be easy to insert, provide adequate primary strength in order to permit rehabilitation Table 1 Summary of the results for non-osteopenic bone (n = 6) a Ultimate failure load (N) after cyclic loading with Wfty cycles per load, beginning with 75 N, values are given as mean and standard deviation, with the range in brackets b Anchor displacement (mm) was measured after the Wrst cycle at 75 N, values are given as mean and standard deviation c Failure modes of the three tested suture anchors varied, given as number of cases Suture anchor Ultimate failure load (N)a Anchor displacement at Wrst cycle at 75 N (mm)b Mode of failure (number of cases)c SPIRALOK 5.0 mm 274 § 29 (242–325) 1.81 § 1.08 Anchor pullout (1), rupture at eyelet (2), suture breakage (not at eyelet) (2), breakage of eyelet (1) Super Revo 5 mm 188 § 34 (150–225) 1.53 § 1.39 Anchor pullout (1), rupture at eyelet (4), suture breakage (not at eyelet) (1) UltraSorb 192 § 34 (150–250) 2.58 § 1.56 Anchor pullout (3), rupture at eyelet (1), suture breakage (not at eyelet) (2) Table 2 Summary of the results for osteopenic bone (n = 6) a Ultimate failure load (N) after cyclic loading with Wfty cycles per load, beginning with 75 N, values are given as mean and standard deviation, with the range in brackets b Anchor displacement (mm) was measured after the Wrst cycle at 75 N, values are given as mean and standard deviation c Failure modes of the three tested suture anchors varied, given as number of cases Suture anchor Ultimate failure load (N)a Anchor displacement at Wrst cycle at 75 N (mm)b Mode of failure (number of cases)c SPIRALOK 5.0 mm 171 § 19 (150–200) 3.47 § 2.87 Anchor pullout (5), rupture at eyelet (1) Super Revo 5 mm 150 § 42 (125–225) 2.06 § 1.63 Anchor pullout (3), rupture at eyelet (3) UltraSorb 151 § 40 (90–200) 2.71 § 1.14 Anchor pullout (5), suture breakage (not at eyelet) (1) 123 Arch Orthop Trauma Surg (2009) 129:373–379 377 exercises, it should not interfere with radiographic diagnos- tic procedures nor generate complications (e.g. osteolysis, cartilage damage by migration, etc.). In case of a revision surgery, the anchor should be either absorbable or easily removable. The ideal, all-needs-fulWlling anchor for rotator cuV repair has not yet been developed. These days, most studies for suture anchors rather approach physiologic conditions in vivo. Contrary to previ- ous studies in which the single-pull to failure technique was used, today we prefer cyclic loading since it is a more accu- rate mode of testing. This new technique simulates the sta- bility of the system in relation to repetitive load [7, 9, 16]. If one compares the maximum failure strength of both test models, the single-pull to failure provides a higher ultimate pullout strength which, however, does not represent the in vivo situation with regard to repetitively occurring loads and the physiologic strength level of the rotator cuV [1, 12, 16]. A successfulrotator cuV repair depends on at least three factors: the condition of the tendon, the anchor material and design, and the bone density at the greater tuberosity [20]. We applied the BMD measurement, which is standard- ized for the lumbar spine, to the humeral head. The results obtained from the humerus cannot be used to diVerentiate the bones with regard to osteoporosis, since no standardized data for the humerus exist. The humeri were only graded according to their bone mineral density into “healthy” and “osteopenic”. The osteopenic bones were all found in the older age group which is consistent with the clinical situa- tion. Many patients with chronic rotator cuV tears are of older age. Various studies to determine the inXuence of bone den- sity at the greater tuberosity and the ultimate failure load of suture anchors have been conducted, but have yielded inconsistent results. For instance, Barber et al. [1] found higher pullout strength (approximately 40%) in the poster- ior area of the greater tuberosity whereas, Tingart et al. [21] reports higher pullout strength in the proximal, ante- rior, and middle area of the greater tuberosity. However, Tingart et al. did not Wnd a correlation of higher pullout strength with an accordingly higher trabecular bone den- sity in the middle and anterior tuberosity, but only with the cortical bone density within the middle range. These Wndings must be seen critically, because the suture anchors used are by default anchored in trabecular bone, not in cortical bone [13]. No diVerence in the ultimate fail- ure load as a function of the implantation position at the greater tuberosity could be detected in our study, which might be due to the limited number of tested anchors at the diVerent positions. In reXecting the correlations between pullout strength and trabecular bone density, signiWcances could be found with the SPIRALOK anchor and with the Super Revo anchor. This permits the conclusion that the tested screwing anchors are the better choice when operating on healthy tra- becular bone, because their ultimate failure load, other than that of the tilting anchor UltraSorb, shows a positive corre- lation between non-osteopenic and osteopenic trabecular bone. Studies, reporting osteolysis by absorbable suture anchors, pertain primarily to PGA polymers [3, 4, 8, 11]. PLA polymers, such as the SPIRALOK 5.0 mm, dissolve more slowly than PGA polymers [8, 10], and therefore bear a smaller risk of foreign body reaction with osteolysis [3, 8]. Yet it still needs to be clariWed whether the radiographic evidence of osteolysis has a correlation with a poor clinical outcome or if it is rather an insigniWcant radiological change without any clinical function. The advantages of using titanium suture anchors, over using absorbable anchors, are the possibility to obtain radiographic evidence of anchor dislocation [13, 16], and the simplicity of the implantation procedure, which does not necessitate pre-drilling and tapping. The titanium anchor is pivoted directly after granulating the bone, without Fig. 5 a Ultimate failure loads of the three tested suture anchors in non-osteopenic bone. b Ultimate failure loads of the three tested suture anchors in osteopenic bone ultimate failure load in healthy bone (n=6) 0 100 200 300 400 * ** Dunn´s Multiple Comparison test: SPIRALOK vs. UltraSorb p 0,05 F m ax [N ] UltraSorb SuperRevoSPIRALOK p 0,05SuperRevo vs. UltraSorb UltraSorbSuperRevoSPIRALOK a b 123 378 Arch Orthop Trauma Surg (2009) 129:373–379 pre-drilling and tapping. The SPIRALOK anchor, however, needs drilling with tapping. After pre-drilling, the UltraSorb tilting anchor is placed in the bone and blocked with a proportioned pull. The titanium anchor Super Revo, has sharper edges than absorbable anchors which results in the occurrence of fre- quent suture tears at the eyelet as shown in several other studies [8, 16]. These tears led consequently to earlier sys- tem failure at a slighter pull. The abrasion of the suture at the sharp edges of the metal plays an important role here. Therefore a stronger suture material such as, ultra high molecular weight (UHMW) suture, that is more resistant to breakage, at the eyelet should be used in order to optimize the performance of the anchor. Abrasion is less pronounced in absorbable anchor material due to the softer material [2, 14, 17]. Further, disadvantages of titanium anchors are problems caused in case of revision surgery and interfer- ence with postoperative imaging studies such as magnetic resonance imaging (MRI). The new SPIRALOK anchor had particularly been developed for soft bones. Its four threads, surrounding a solid, non-cannulated tapered inner core, Wx the anchor Wrmly in the trabecular bone. An important aspect in anchor design when it comes to better bone anchorage is the broad and Xat rising threads with large distances between the individual threads. The SPIRALOK anchor’s pullout strength in the total evaluation (non-osteopenic and osteopenic bones) was by 31% higher than that of the Super Revo, and by 30% higher than that of the Ultra- Sorb anchor. The best pullout performance, both on healthy and on osteopenic bones was conducted by the SPIRALOK anchor. However, no signiWcantly higher pullout strength in the osteopenic bones could be detected. It has to be mentioned, that the tested titanium anchor Super Revo has only three threads anchoring in the trabecular bone. It seems likely that other titanium anchors with more threads might yield better results. There- fore, it can be assumed that the design of the anchor plays a greater role in the primary stability than the materials used. Conclusion The data of our study suggest that the SPIRALOK anchor appears to be of equal dependability in osteopenic bone to the other two anchors tested, and perhaps of even better dependability in non-osteopenic bone. The use of UHMW sutures also contributes to higher system stability, since several anchor failures with the Super Revo were caused by suture breakage. The design of the anchor seems to play a greater role than the materials used, regarding the primary stability. Considering the advantages of absorbable suture anchors, such as better acceptance by patients, minimized interference with postoperative imaging, less complicated revision surgery and comparable pullout strength, absorb- able suture anchors should be given precedence over non- absorbable ones. References 1. 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J Bone Joint Surg Am 85-A(11):2190–2198 123 Suture anchor Wxation strength in osteopenic versus non-osteopenic bone for rotator cuV repair Introduction Materials and methods Specimen preparation Measurement of bone density Suture anchors Placing the suture anchors Biomechanics Statistical analysis Results Bone density measurements Alternating anchor implantation sites System stability: displacement after the Wrst pull with 75 N Modes of failure Ultimate failure load Correlation between bone mineral density and pullout strength Discussion Conclusion References > /ColorImageDict > /JPEG2000ColorACSImageDict > /JPEG2000ColorImageDict > /AntiAliasGrayImages false /DownsampleGrayImages true /GrayImageDownsampleType /Bicubic /GrayImageResolution 150 /GrayImageDepth -1 /GrayImageDownsampleThreshold 1.50000 /EncodeGrayImages true /GrayImageFilter /DCTEncode /AutoFilterGrayImages true /GrayImageAutoFilterStrategy /JPEG /GrayACSImageDict > /GrayImageDict > /JPEG2000GrayACSImageDict > /JPEG2000GrayImageDict > /AntiAliasMonoImages false /DownsampleMonoImages true /MonoImageDownsampleType /Bicubic /MonoImageResolution 600 /MonoImageDepth -1 /MonoImageDownsampleThreshold 1.50000 /EncodeMonoImages true /MonoImageFilter /CCITTFaxEncode /MonoImageDict > /AllowPSXObjects false /PDFX1aCheck false /PDFX3Check false /PDFXCompliantPDFOnly false /PDFXNoTrimBoxError true /PDFXTrimBoxToMediaBoxOffset [ 0.00000 0.00000 0.00000 0.00000 ] /PDFXSetBleedBoxToMediaBox true /PDFXBleedBoxToTrimBoxOffset [ 0.00000 0.00000 0.00000 0.00000 ] /PDFXOutputIntentProfile (None) /PDFXOutputCondition () /PDFXRegistryName (http://www.color.org?) /PDFXTrapped /False /Description /DEU>> >> setdistillerparams > setpagedevice