Aims. To draw a comparison of the pullout strengths of buttress thread, barb thread, and reverse buttress thread bone screws. Methods. Buttress thread, barb thread, and reverse buttress thread bone screws were inserted into synthetic cancellous bone blocks. Five screw-block constructs per group were tested to failure in an axial pullout test. The pullout strengths were calculated and compared. A finite element analysis (FEA) was performed to explore the underlying failure mechanisms. FEA models of the three different screw-bone constructs were developed. A pullout force of 250 N was applied to the screw head with a fixed bone model. The compressive and tensile strain contours of the midsagittal plane of the three bone models were plotted and compared. Results. The barb thread demonstrated the lowest pullout strength (mean 176.16 N (SD 3.10)) among the three thread types. It formed a considerably larger region with high tensile strains and a slightly smaller region with high compressive strains within the surrounding bone structure. The reverse buttress thread demonstrated the highest pullout strength (mean 254.69 N (SD 4.15)) among the three types of thread. It formed a considerably larger region with high compressive strains and a slightly smaller region with high tensile strains within the surrounding bone structure. Conclusion. Bone screws with a reverse buttress thread design will significantly increase the pullout strength. Cite this article: Bone Joint Res 2021;10(2):105–112

Good lag screw holding power in trabecular bone of the femoral head is a requisite to achieve stability in the management of proximal femoral fractures. It has been demonstrated that insertion torque and pullout strength of lag screw are linearly correlated. Therefore, insertion torque measurement could be a method to estimate the achieved screw purchase. Manual perception is not reliable [1], but the use of an instrumented screwdriver would make the procedure feasible. The aim of this study was to assess the accuracy achievable using the insertion torque as predictor of lag screw purchase. Four different screw designs (two cannulated and two solid-core screws) were investigated in this study. Each screw was inserted into a block of trabecular bone tissue following a standardised procedure designed to maximise the experimental repeatability. The blocks of trabecular tissue were extracted from human as well as bovine femora to increase the range of bone mineral density. The prediction accuracy was evaluated by plotting pullout strength versus insertion torque, performing a linear regression analysis and calculating the difference (as percentage) between predicted and measured values. Insertion torque showed a strong linear correlation (coefficient of determination R. 2. : 0.95–0.99) with the pullout strength of lag screw. However the prediction error in pullout strength estimation was greater than 40% for small values of insertion torque, decreasing down to 15% when the lag screw was driven into good quality bone tissue. Measuring insertion torque can supply quantitative information about the achieved lag screw purchase. Since screw design and insertion procedure have been shown to affect both the insertion torque and the pullout strength [2], the prediction model must be screw-specific and determined, closely simulating the clinical procedure defined by the screw manufacturer. However, the surgeon must be aware that, even under highly repeatable experimental conditions, the prediction error was found to be high when small insertion torque was measured, i.e. when the screw was driven in low quality bone tissue. Therefore, insertion torque is not reliable in evaluating lag screw purchase in the management of proximal femur fracture of osteoporotic patients

The influence of the intravertebral length of vertebral screws on their pull out strength. 64 Cadaveric vertebrae of different lumbar levels were used. By means of Computer Tomography the length of the screw in the bone was assessed. The ratio screw length in bone to the longest possible screw in bone was built. Biomechanical Pullout tests and statistical correlation analysis were then performed. The maximum pullout strength was 1602 N and the minimum pullout strength was 96,4 N (SD 356,9 N). The maximum ratio of the inserted screw was 95,9% and the minimum was 58,8% (SD 0,7%). There is no statistically significant correlation between the ratio of the inserted screw and the pullout strength needed. Moreover, there is a statistically significant correlation between bone mass density and pullout strength (p< 0,05). The fixation of pedicle screws is better in a non osteoporotic vertebral body. Pullout strength and bone mass density correlate significantly whereas there is no correlation between the insertion length of the screw and the pullout strength under the condition that the insertion ratio is greater than 58,8 %. Factors such as insertion angle of the screw need to be evaluated, and new techniques for pedicle screw fixation in osteoporotic vertebrae need to be developed

Absorbable suture anchors have become more and more important in rotator cuff surgery due to their easy revisability. In osteoporotic bone however they are thought to be of minor primary stability. Purpose of the present study was to compare different absorbable and non-absorbable suture anchors in their pullout strength depending on bone density. The absorbable screw-anchor SPIRALOK5mm (DePuyMitek, Raynham, MA, USA), the titanium screw-anchor SUPER-REVO5mm and the tilting-anchor ULTRASORB (both ConmedLinvatec, Largo, FL, USA) were tested, each anchor representing a different material and design. On the basis of bone density measurement by CT-scans a healthy (mean-age. 42 years) and a osteopenic (mean-age: 74 years) group of cadaveric human humeri were formed. Each anchor was inserted in the greater tuberosity six times. They were inserted according to the manufacturers instructions with the supplied suture material. An incremental cyclic loading was performed, starting with 75N. Until failure the tensile load was increased by 25N after every 50 cycles. The ultimate failure loads, the anchor displacements and the modes of failure were recorded. In the non-osteopenic bone group, the absorbable SPIRALOK achieved a significantly better pullout strength (mean: 274N) than the titanium screw-anchor SUPER-REVO (mean: 188N) and the tilting-anchor ULTRASORB (mean: 192N). In the osteopenic bone group no significant difference 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. In the osteopenic group the number of anchor pullouts clearly increased. The present study demonstrates that absorbable suture anchors do not have lower pullout strengths than metal anchors. Depending on their design they can even outmatch metal anchor systems. The results of our study suggest that the anchor design has a crucial influence on primary stability, whereas the anchor material is less important

Background. While the biomechanical properties of trans-pedicular screws have proven to be superior in the lumbar spine, little is known concerning pullout strength of trans-pedicle screws in comparison to different distal terminal constructs like sublaminar hooks alone, trans pedicular screws with sublaminar hooks and clow hooks alone in the thoracolumbar spine surgery. In vitro biomechanical pullout testing was performed to evaluate the axial pullout strength of four different distal terminal constructs in thoracolumbar spine surgery. Methods. 32 fresh-frozen lamb spines were used. The lamb spines were divided into four groups, each group is composed of eight lamb spine cadavers with a different distal fixation pattern was used to terminate the construct at L1. (Group 1) trans-pedicular screws alone, (Group 2) sublaminar hooks alone, (Group 3) trans-pedicular screws augmented with a sublaminar hooks via a domino connector and (Group 4) clow hooks alone. Results. The average pullout strength of group 1 was 927N, group2 was 626N, group 3 was 988N and group 4 was 972N. Group 3 and 4 showed the most significant pullout forces when compared to group 1 and group 2. However Group 3 and group 4 didn't show any significant statistical difference when compared to each others. Conclusion. Our study thus suggests that the strongest construct that may reduce the pullout phenomina in the distal fixation constructs are the trans-pedicular screw with laminar hooks. It is strongly advised to be used in osteoporotic bones and in conditions where pullout strength is required to be enhanced. But farther prospective clinical studies are needed to clearly demonstrate the beneficial effect of a trans-pedicular screw augmented with a laminar hooks in reducing the risk of distal instrumentation pullout. Level of Evidence. Level 5. Disclosure. The authors declare that no conflict of interests were associated with the present study

The radiological and biomechanical assessment using cement augmented cannulated pedicle screw (Biomet. ®. , Omega 21. ®. ) and the correlation of the cement volume to the pullout strength needed for each screw. Cadaveric vertebrae of different lumbar levels were used. Through cannulated pedicle screw a definite volume of cement was applicated. The bone volume occupied by cement was assessed by means of segmentation after Computer Tomography. Biomechanical Pullout tests and statistical correlation analysis were then performed. The maximum pullout strength was 1361 N and the minimum pullout strength was 172 N (SD 331 N). The maximum cement volume was 5,29 cm3 and the minimum 1,02 cm3 (SD 1,159). The maximum cement diameter was 26,6 cm and the minimum cement diameter was 20,7 cm (SD 1,744). There is statistically significant correlation between the pullout strength and the injected cement volume (p< 0,05). The cannulated pedicle screw was used for a better fixation in the vertebral body. The cement augmentation with this technique is easier and seems to be safer than cement augmentation of non cannulated screws. Pullout strength of the cannulated screws correlates positively with the cement volume. It is though not influenced either by the total vertebral volume or by the ratio cement volume to vertebral volume or by the maximum diameter of the cement drough

Suture anchor have been used in surgical procedure of tendon or ligament repair. Recently, there has been developed an all suture anchor (soft anchor) which can be used even when the insertion area is narrow. But, the stability of soft anchors due to narrow zone has not been elucidated. This purpose of this study was to investigate stability of soft anchors with respect to their fixation intervals. Polyurethane foams with two different bone densities (10 pcf; 0.16g / cm³, 20 pcf; 0.32g / cm³) were used. All suture anchors and conventional suture anchors were fixed at 10mm, 5mm, and 2.5mm intervals. The failure load was measured using a mechanical testing machine. The average load to failure of conventional suture anchor were 200.4N, 200.2N, 184.7N in the 10mm, 5mm and 2.5mm interval with 10pcf foam bones and 200.4 N, 200.2 N and 184.7 N with the 20 pcf foam bone respectively. Average load to failure load of soft anchor was 97.3N, 93.9N and 76.9N with 10pcf foam bones and 200.4 N, 200.2 N and 184.7 N with 20 pcf foam bone. Suture screw spacing and bone density are important factors in anchor pullout strength. In osteoporotic bone density, insertion of the suture screw interval of 5 mm might be necessary

In this biomechanical study of isolated porcine C2 vertebrae, antero-posterior forces were applied to potted specimens. Bipedicular fractures were generated in 25.4% of fifty-nine specimens (others fractured mostly through laminae). Bipedicular fractures were subsequently fixed under direct vision with trans-pedicular lag screws. These fixed specimens were then tested again. The mean ultimate tensile strength of the construct was 27.1% compared to the native bone’s fracture strength in the same specimen. This is a good model for hangman’s fracture, and is relevant to newer constructs that utilize C2 pedicle screws as part of a larger instrumentation procedure. Hangman’s fracture rarely needs internal fixation. However, if fixation is indicated the fracture can sometimes be directly fixed with trans-pedicular screws rather than fusing C1-C2 and committing to a great loss of neck range of motion. To our knowledge, the actual pullout strength of pedicle screws in C2 is previously unreported. Hence, we developed a laboratory model of hangman’s fracture by applying antero-posterior tensile force in fifty-nine porcine specimens that were stripped of soft tissues. The failure strength of the bone averaged approximately 3200 N, and subsequent fixation averaged to 27.1% of this value. Regardless of pre-hoc expectations, these values indicate that the screw purchase is strong enough to consider continued use of the procedure in repair of hangman’s fracture, fixation to C2 of multi-level constructs, and so forth. Multiple anterior and posterior screw procedures have been tested in the past, but to our knowledge the pullout strength of C2 pedicle screws has not been examined. Because the usage of C2 pedicle screws is growing in popularity, this biomechanical information is pertinent to work in traumatic, degenerative, and reconstructive procedures. Some limitations of the present study are that the specimens were porcine rather than human, and that only fixation to single vertebrae was examined. Funding: Dr Kaspar holds academic research grants from McMaster University and from The Physicians’ Services Incorporated (PSI) Foundation, the former of which was used to finance this project. There are no commercial grants or conflicts of interest

This is a biomechanical study measuring the maximum pull-out strength of implants inserted into vertebral bodies of the calf spine. The objective is to investigate the influence of different anchoring systems. The following implants were used: Zielke USIS (Ulrich, Ulm), Kaneda KASS (DePuy, Sulzbach). Universal Spine System (USS, Synthes, Umkirch) and Hollow Modular Anchorage (HMA) system (Aesculap, Tuttlingen). We selected nine groups with seven vertebrae equal in mean sizes and Bone Mineral Density (BMD) for each system. Vertebral body and implant were connected to both ends of a servohydraulic testing machine. Distraction was applied until failure and the maximum axial pullout force was recorded. No significant correlation of BMD and pullout strength appeared. The student t-test showed significant higher stability for USS with pullout resistant nut (4.0 kN) and KASS (two-screws, 4.2 kN) compared to all other systems (p < 0.025). The mode of failure was a burst fracture in these vertebrae and shearing in all other systems. Bicortical screws of USS (3.2 kN) showed stronger hold than single bicortical KASS (2.5 kN) and HMA 12 mm (2.6 kN). Zielke (2.1 kN) was equal to monocortical KASS (one screw 2.1 kN) and superior to monocortical USS (1.6 kN). All those provided less stability than HMA 14 mm (2.4 kN). For in-vitro testing with calf spines the influence of BMD seems to be less important than that of implant design. Maximum strength of Kaneda KASS depends on angulation of screws. Stability of USS implants can be increased by use of pullout resistant nuts. Of all monocortical implants only HMA presents pullout resistant strength comparable to bicortical screws. In-vivo use of monocortical anchorage bears the lowest risk of vascular injury, because the far cortex remains intact

We compared initial fixation strength of two commonly used tibial side hamstring ACL reconstruction fixation implants – the RCI interference screw and the Intrafix device.

Using a sheep model 36 hamstring grafts were prepared and implanted into the distal femoral metaphyseal bone using either a RCI screw or an Intrafix device. They were then pulled out until failure using an Instron Materials Testing Machine. Maximum strength of graft fixation and mode of failure were recorded.

The average strength of the graft was 48kg using the RCI screw and 90 kg using the Intrafix device. This difference was statistically significant. The maximum pull-out strength was 91kg for the RCI screw and 130 kg for the Intrafix device. The most common mode of failure in the RCI screw fixation was graft shredding on the screw and whole graft pullout whereas in the Intrafix device it was intratendinous failure.

The Intrafix device demonstrated a clear strength advantage over the RCI screw with regard to initial fixation strength. The Intrafix device may reduce tibial side graft creep which is a problem with hamstring ACL reconstruction.

Aims

This study aimed to establish the optimal fixation methods for calcaneal tuberosity avulsion fractures with different fragment thicknesses in a porcine model.

Introduction: With non-fusion stabilization surgery technique, the demands on the pedicle screw system have increased. The screw implants require a high press fit for optimum bone integration and a high pullout strength to guarantee primary stability. We compared the cylindrical screw design from a pedicle screw system with the conical design in regard to the insertional torque and pullout strength. Methods: Three human cadaver specimens L1 – L5 (15 vertebrae, 30 pedicles) were fitted with pedicle screws on both sides. The pedicles were randomized to one of two screw types: 1) cylindrical pedicle screw, 2) conical. A computer tomographic bone density measurement was performed beforehand. The insertional torque was measured while inserting the pedicle screws. The correct position of the screw was verified using computer tomography. In order to test the pullout strength, the preparations were divided up into individual vertebrae and fixed. Results: The mean peak insertional torque for the conical screws was significantly higher than that for the cylindrical screws. The pullout strength showed no significant difference between the two types of pedicle screws. With both the conical and the cylindrical pedicle screws, the pullout strength and insertional torque significantly decreased with decreasing bone density in the preparations. Conclusions: Statements in the literature about the effect on insertional torque and pullout strength of using a conical or cylindrical pedicle screw design vary. The two screw designs in our study only differed in regard to their internal diameter. The significantly higher insertional torque values found for the conical screws could describe the improved screw press-fit behavior. The pullout strength was not significantly affected by the conical design. No correlation was found between the insertional torque and pullout strength. In order to optimize the adjustment of insertional torque and pullout strength, we recommend the conical pedicle screw design for non-fusion surgical techniques for the surgical treatment of degenerative diseases of the lumbar spine

The effect of screw geometry on the pullout strength of Anterior Cruciate Ligament [ACL] reconstruction is well documented. Most research has looked at the effect of screw length and diameter, however other factors such as the degree of taper may also be important. Tapered screws should in theory be associated with increased pullout strength. This has not been demonstrated either clinically or in vitro before. The aim of this study was to compare the pullout strength of ACL reconstruction with a parallel against a tapered screw. A parallel and tapered screw were manufactured which were identical in all other respects. Sixty superficial digital flexors from the hind legs of sheep were harvested. The tendons were paired and combined to form a quadruple tendon reconstruction of approximately 7mm diameter as measured with graft sizer. An ACL reconstruction was performed on the proximal tibia of 30 bovine knees, which had been harvested in right and left knee pairs, using the quadruple tendon. Fifteen reconstructions were fixed using tapered screws and fifteen with non-tapered screws. The insertion torque of both tapered and non tapered screws were recorded using an instrumented torque screwdriver. The reconstructions were mounted in an Instron materials testing machine with an x-ray bearing system to eliminate horizontal forces, to ensure that the forces were all directed along the line of the tibial tunnel. The maximum pullout strengths were recorded in each case. Five knee pairs were subjected to bone densitometry scanning to ensure that any difference in pull out strength was not due to changes in bone density between right and left knee pairs. Results indicated that there was no difference between right and left knee pairs [p = 0.58] and that tapered screws were associated with significantly higher pull-out strengths [p=0.007] and insertion torques [p = 0.001]

Introduction. Conventional screws achieve sufficient insertion torque in healthy bone. In poor bone screw stripping can occur prior to sufficient torque generation. It was hypothesized that a screw with a larger major/minor diameter ratio would provide improved purchase in poor bone as compared to conventional screws. We evaluated the mechanical characteristics of such a screw using multiple poor bone quality models. Methods. Testing groups included: conventional screws, osteopenia screws used in bail-out manner (ie, larger major/minor diameter screws inserted into a hole stripped by a conventional screw), and osteopenia screws used in a preemptive manner (ie, no screw stripping occurrence). Stripping Torque: Screws were inserted through standard straight plates into a low density block of foam with a predrilled hole. Stripping torque was defined as maximum insertion torque reached by the screw before the screw began to spin freely in the foam. Pullout. Pullout tests were conducted on screws inserted into the same test media. Axial pull-out testing was then conducted by applying a tensile load to the screws. Compression. Screws were inserted through standard straight plates by hand while the amount of compression achieved between plate and bone was measured using a pressure sensor. The same foam test media was utilized in addition to osteoporotic fresh-frozen femoral diaphyseal cadaver (bone mineral density<0.60 g/cm2). The screws were tightened across a range of possible insertion torques with pressure measurements taken at multiple intervals. Results. The osteopenia bone screws showed a 67% increase in torque before stripping occurred (p<0.01) when compared to the conventional screw. The osteopenia screw used in a bail-out manner showed a 57% increase in stripping torque (p<0.01) and a 76% increase in pullout strength (p<0.01) when compared to the conventional screw. Additionally, the bail-out screw showed a minimal decrease in both stripping torque (6%, p = 0.45) and pullout strength (11%, p<0.01) when compared to the osteopenia screw tested in preemptive manner. There was a linear relationship between applied torque and compressive force generation for both osteopenia and conventional screws. The osteopenia screws were able to gain greater compression against bone across a range of insertion values as compared to conventional bone screws. Discussion. The osteopenia screw achieved superior stripping torque, pullout strength, and compressive forces when compared to conventional screws in simulated poor quality bone and osteoporotic cadaver bone. When used as a bail-out screw, it also achieved superior stripping torque and pullout strength. The results of this study indicate that a screw of larger major/minor diameter ratio could be an effective bail-out option for screw stripping associated with osteopenic fracture fixation

There are three basic concepts that are important to the biomechanics of pedicle screw-based instrumentation. First, the outer diameter of the screw determines pullout strength, while the inner diameter determines fatigue strength. Secondly, when inserting a pedicle screw, the dorsal cortex of the spine should not be violated and the screws on each side should converge and be of good length. Thirdly, fixation can be augmented in cases of severe osteoporosis or revision. A trajectory parallel or caudal to the superior endplate can minimise breakage of the screw from repeated axial loading. Straight insertion of the pedicle screw in the mid-sagittal plane provides the strongest stability. Rotational stability can be improved by adding transverse connectors. The indications for their use include anterior column instability, and the correction of rotational deformity

Introduction. Short-segment posterior instrumentation for spine fractures is threatened by unacceptable failure rates. Two important design objectives of pedicle screws, bending and pullout strength, may conflict with each other. Hypothesis. Multiobjective optimization study with artificial neural network (ANN) algorithm and genetic algorithm (GA). Materials & Methods. Three-dimensional finite element (FE) methods were applied to investigate the optimal designs of pedicle screws with an outer diameter of 7 mm using a multiobjective approach for these two objectives. Based on the FE results on an L25 orthogonal array, two objective functions were developed by an ANN algorithm. Then, the trade-off solutions known as Pareto optima were explored by a GA. The optimal design was validated by mechanical tests. Results. The knee solutions of the Pareto fronts had simultaneous high bending and pullout strength ranging from 92 to 94 percent of their maxima. The corresponding range of the design parameters was 3.8 to 4.06 mm for inner diameter and 3.21 to 3.3 mm for pitch; 0 mm for beginning position of conical angle, 0.4 mm for proximal root radius, 5 degrees for proximal half angle, and 0.1 mm for thread width. The optimal design was well validated by mechanical tests, comparing with commercially available pedicle screws. Discussion & Conclusions. The optimal design of pedicle screws obtained could achieve an ideal with high mechanical performance in both bending and pullout tests

The aim was to compare the initial pull out strengths of various interference screw devices used for tibial fixation of hamstring grafts and the effect of concentric or eccentric screw position. Quadrupled tendon grafts were harvested from freshly killed sheep. The grafts were then prepared and fixed in the distal femur using various devices (Intrafix, RCI screw, Wedge screw +/− transfix pin, screw and post) in both concentric and eccentric positions. A single load to failure test was then performed. The highest pull out strength was with the Intrafix device inserted concentrically (mean 941N). This was significantly higher than the wedge screw inserted concentrically (737N) (p=0.015). This in turn had significantly greater initial pull out strength than the wedge eccentric with post or pin (p=0.03) and the RCI screw (464N) (p=0.00036). In this sheep model the Intrafix device inserted concentrically had a significantly greater initial pull-out strength than the other interference screws tested. Concentric positioning of an interference screw gave significantly greater initial pullout strength of a quadruple hamstring graft than eccentric positioning. Addition of a cross pin or post made no difference to initial pullout strength

INTRODUCTION. In native knees the anterior cruciate ligament (ACL) plays a major role in joint stability and kinematics. Sacrificing the ACL in contemporary total knee arthroplasty (TKA) is known to cause abnormal knee motion, and reduced function. Hence, there is growing interest in the development of ACL retaining TKA implants. Accommodation of ACL insertion around the tibial eminence is a challenge with these designs. Therefore, a reproducible and practical test setup is necessary to characterize the strength of the ACL/bone construct in ACL retaining implants. Seminal work showed importance of loading the ACL along its anatomical orientation. However, prior setups designed for this purpose are complex and difficult to incorporate into a standardized test for wide adoption. The goal of this study was to develop a standardized and anatomically relevant test setup for repeatable strength assessment of ACL construct using basic force-displacement testing equipment. METHODS. Cadaver knees were positioned with the ACL oriented along the loading axis and being the only connection between femur and tibia. 15° knee flexion was selected based on highest ACL tensions reported in literature. Therefore, the fixtures were adjusted accordingly to retain 15° knee flexion when the ACL was tensioned. The test protocol included 10 cycles of preconditioning between 6N and 60N at 1mm/s, followed by continuous distraction at 1mm/s until failure (Fig. 1). Eleven cadaveric knees (4 male, 7 female; 70.9 yrs +/−13.9 yrs) were tested using this setup to characterize a baseline ACL pullout strength (peak load to failure) in native knees. RESULTS. The average ACL pullout strength was 935.6N +/−327.5N with the extremes ranging from a minimum of 346N to a maximum of 1425N. There were five failure modes observed: [1] ACL avulsion from the femur with bony attachment (one knee), [2] ACL pull-off from the femur w/o bony attachment (two knees), [3] ACL tear (three knees), [4] ACL pull-off from the tibia w/o bony attachment (one knee), [5] ACL avulsion from the tibia with bony attachment (three knees). One knee showed a combined failure mode of 2 & 4, meaning part of the ACL was pulled off the femur and part pulled off the tibia. CONCLUSION. There was a large variation in failure load between specimens. The knee with the minimum failure load had severe arthritis, osteophytes and signs of ACL deficiency. The average failure load (935.6N +/−327.5N) is in line with those published in literature for a comparable age group. This indicates that failure loads and modes obtained with more complex setups could be reproduced by using standard uniaxial load frames and simple fixtures. The failure modes in our experiment were evenly spread between mid-substance, and insertions (either femur or tibia). This test could be used as a standardized method to investigate the strength of the ACL complex following procedures such as ACL reconstruction, partial- and total knee arthroplasty. In particular, this setup provides a reliable mechanism for evaluation of the ACL-bone construct in bi-cruciate retaining (BCR) TKA, which is likely required for regulatory pathways

Objectives. The purpose of this study was to evaluate chronological changes in the collagen-type composition at tendon–bone interface during tendon–bone healing and to clarify the continuity between Sharpey-like fibres and inner fibres of the tendon. Methods. Male white rabbits were used to create an extra-articular bone–tendon graft model by grafting the extensor digitorum longus into a bone tunnel. Three rabbits were killed at two, four, eight, 12 and 26 weeks post-operatively. Elastica van Gieson staining was used to colour 5 µm coronal sections, which were examined under optical and polarised light microscopy. Immunostaining for type I, II and III collagen was also performed. Results. Sharpey-like fibres comprised of type III collagen in the early phase were gradually replaced by type I collagen from 12 weeks onwards, until continuity between the Sharpey-like fibres and inner fibres of the tendon was achieved by 26 weeks. Conclusions. Even in rabbits, which heal faster than humans, an observation period of at least 12 to 26 weeks is required, because the collagen-type composition of the Sharpey-like fibre bone–tendon connection may have insufficient pullout strength during this period. These results suggest that caution is necessary when permitting post-operative activity in humans who have undergone intra-bone tunnel grafts

Introduction: Existing fatigue studies of ACL fixation have two disadvantages. There is no agreed standard protocol, making comparison of various studies difficult and average results are presented, disregarding data spread. This may be over-optimistic, because approximately half the fixations will not achieve the average level. The effect of data spread can be summarised using the one-sided 80/80 lower tolerance limit (LTL). This LTL indicates the strength that at least 80% of fixations will reach, with an 80% probability. It is commonly used in engineering. We fatigue-tested a new resorbable composite screw (PLLA/tri-calcium phosphate) and a metal interference screw. We present average data and tolerance limits. Methods: Porcine BPTB grafts (Ø=9mm) were fixed inside tibial tunnels (Ø=10mm) using composite or metal screws. Each screw was tested for static pull-out strength (n=6) and cyclic loading to failure at 330N and 415N (n=5 each level). Means and standard deviations of pullout strength were compared. Log-log curves were fitted between force level and cycles to failure. LTLs were calculated. Results: During static loading, all repairs failed by graft pullout or tissue failure. During cyclic loading, all except one graft fixed with composite screws failed by pullout. Grafts fixed with metal screws failed by bone fracture in 60% of the cases. A composite screw loaded at 300N would last on average 272 cycles or at least (LTL) 7 cycles. At 200N the average and LTL were 38,218 and 966 cycles. Corresponding values for the metal screw were 263 (mean) and 12 (LTL) at 300N; and 12,454 and 564 at 200N. Discussion and Conclusions: Repairs with metal screw had higher pullout strength, but proved more prone to fatigue. Higher incidence of bone graft fracture in fatigue testing with metal screws suggests that their sharp threads act as stress risers. Fatigue testing of ACL reconstructions shows wide variation, due to several factors. Average levels are therefore over-optimistic and tolerance limits gives a better indication of screw performance. We suggest that tolerance limits should be reported in future studies