e ICONIX family of anchors symolise the next generation of suture anchor technology. e all suture based system allows for less bone removal during pilot hole. 21 ICONIX Obturator. 21 ICONIX Drills/Awl. 21 Tray. 22 ICONIX TT All Suture Anchor System. 23 ReelX STT Knotless Anchor System. 24 Knotilus Knotless. MAHWAH, N.J., March 13, /PRNewswire/ — Stryker announced today the launch of the ICONIX™ all suture anchor platform with.
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All-suture anchors are increasingly used in rotator cuff repair procedures. Potential benefits include decreased bone damage.
However, there is limited published evidence for the relative strength of fixation for all-suture anchors compared with traditional anchors. Ultimate load to failure, gap formation at 50,and cycles, and failure mechanism were recorded.
Mechanical properties of all-suture anchors for rotator cuff repair
Overall, mean maximum tensile strength values were significantly higher for the traditional anchor The JuggerKnot anchor had greatest displacement at 50, and cycles, and at failure, reaching statistical significance over the control at and cycles We demonstrate decreased failure iconkx, increased total displacement, and variable failure mechanisms in all-suture anchors, compared with traditional anchors designed for rotator cuff repair.
Mechanical properties of all-suture anchors for rotator cuff repair. Bone Joint Res ;6: Anchorage of sutures in the repair of rotator cuff RC stfyker has traditionally made use of large, screw-shaped anchors consisting of either metal or plastic polymer materials to secure sutures into bone. However, over the last decade, a novel fixation technique has emerged.
Placement of all-suture uconix generally involves drilling a small pilot hole into the bone, and subsequently placing suture material in a strryker configuration attached to a catheter device, which allows the suture to expand in the cancellous bone under the cortex struker the strykker is removed.
Previous studies have endeavoured to look into the mechanical properties of all-suture anchors and compare these with traditional bone anchors. Furthermore, studies have shown the maximum tensile strength of anchors to range from 49 N to 66 N in one paper, 8 to N in another, 5 highlighting the need for a comprehensive evaluation of all commercially available all-suture anchors in comparison with traditional anchors.
The aim of this study was to compare the mechanical properties failure load and cyclic displacement and failure mechanisms of all-suture anchors with those of a traditional suture anchor in cadaveric human humeral heads. The null hypothesis of the study was that the mechanical properties and failure mode of novel commercial all-suture anchors would be the same as those of a traditional bone anchor.
The humeral heads were dissected from cadaveric donors and overlying soft-tissue was debrided to expose the bone surface over the greater tuberosity. The humerus was isolated from the distal upper limb strjker cm below its surgical neck.
All samples were kept hydrated in 0. A review of idonix literature and a search through the procurement department of our tertiary referral centre hospital was conducted to determine current commercially available all-suture anchors accurate as of Aprilof which four were found. All four types of commercially available all-suture anchors and one traditional plastic anchor were obtained from the manufacturers.
All tested anchors had polyethylene flat braided ultra-high molecular weight polyethylene UHMWPE ; Y-Knot or braided polyester 2 sutures for tendon interfaces. All described anchors are indicated for both open and arthroscopic RC repair. Variations in size and suture type are available for other procedures including repair of Bankart and SLAP superior labral tears from anterior to posterior lesions, biceps tenodesis, acromioclavicular joint dislocation reconstruction, deltoid repair and capsulolabral repair.
However, these sizes were not tested. Initially, a guide is placed over the greater tuberosity before a self-tapping 2. The awl is removed and the anchor is placed through the guide and, using a mallet, advanced until a positive strtker is achieved. The suture ends are untethered from the anchor inserter, and both the inserter and guide are removed.
It should be noted that other sizes of ICONIX anchor are available and indicated for RC repair surgery, however, literature published by the manufacturer states that the ICONIX 3 is the strongest defined by maximum tensile strength anchor within the range. The implant is placed by pushing a drill guide and associated obturator through soft tissues until they approximate cortex.
Stryker Launches Iconix All Suture Device for Orthopedic Arthroscopy
Once the soft tissue has been navigated, the obturator is removed, leaving the drill guide overlying the cortex. A 3 mm drill bit is placed through the drill guide to breach the cortex and create a bone hole — this is terminated when the drill xtryker onto the guide and no further progress can be made.
strykre The drill is subsequently removed and replaced with the Q-FIX implant inserter which goes into the guide. There are two possible insertion techniques for placement sryker the Y-Knot. The first, a self-tapping technique, involves placing the tip of the inserter on to the cortex and subsequently using a mallet to impact the inserter with suture attached into the bone. Circumferential laser-marks indicate the range of the depth to which the inserter can be pressed. A second option, for harder bone, is to create a dtryker.
Thereafter, sutures are unwound from the inserter and the construct is sryker. All suture strands are then pulled and the anchor is compressed against the cortical bone. After initially boring through the cortex with a 2. The humeral shaft was pierced along its length and secured within a custom-designed platform with screws. The suture threads emerging from the humeral head were secured within the upper clamps of the rig, with no recorded failure in any repeats at the suture-vice interface Fig.
The experimental construct used to determine maximum tensile strength and displacement.
Cyclical loading using a previously published protocol to simulate the rehabilitation phase of post-rotator cuff tendon repair 12 was used see supplementary material. An initial 10 N tension was iconnix on the anchors to ensure proper deployment of the subcortical segment of the all-suture anchors and to prevent loading artefacts. Mechanism of failure suture or interface was also recorded.
Cadaveric samples were distributed such that a combination of left and right humeral heads from the same patient were used with different anchors, and different anchors were used with different cadaver ages to ensure matched ages and stryke amongst samples. Kruskal-Wallis one-way analyses were performed to compare the tensile mechanical properties of the different commercial suture anchors and traditional bone anchor to determine tsryker variance.
Post hoc analysis was performed using the Dunn test. Mechanical properties and failure mechanisms observed of tested anchors 13 Displacement values mm of tested anchors.
ICONIX anchors did not reach cycles and Q-FIX anchors did not reach cycles, therefore data stry,er not included; standard error se at cycles is not described for all anchors as anchors failed before this point. Maximum iconkx strength was significantly greater in the control anchor mean and standard error: JuggerKnot and Y-Knot anchors Maximum tensile strength of all-suture anchors and a traditional bone anchor as assessed to failure. Error bars represent standard error. The mean maximum tensile strength value was significantly higher for the traditional anchor Displacement, after initial application of load, was recorded during cyclic loading.
Comparisons were not made at cycles as the majority of anchors failed before this point The JuggerKnot anchor had the greatest displacement at 50, and cycles and also at failure, though this did not reach statistical significance over any other all-suture anchors Table II apart from the Q-FIX anchor at failure Fig.
The JuggerKnot anchor did have significantly greater displacement over control anchors at and cycles Displacement of all-suture anchors as determined by changes in grip-to-grip distance over increasing cycle numbers and eventually to failure. Error bars represent upper limits of standard error to demonstrate maximum displacement. With the exception of the Q-FIX 4. Moreover, all anchors demonstrated significant displacement between 0 and 50 cycles range 6. The JuggerKnot implant had the greatest increase in displacement between 50 and cycles, with mean displacement of Otherwise, there was no significant variation between displacement values of the anchors.
Additional analysis of displacement was performed to determine changes in displacement differentials after the first 50 cycles to accommodate initial anchor settling. Displacement between 50 and cycles, 50 and cycles, and 50 cycles to failure were determined Table III. Mean displacement differential values and standard error se mm of tested anchors between 50 cycles and: Between 50 and cycles, the JuggerKnot demonstrated the greatest mean displacement A similar pattern was found between cycles 50 andwhereby the JuggerKnot anchor had the greatest displacement However, when comparing displacement between 50 cycles and failure, there was no statistically significant variation between anchors.
Mechanical properties of all-suture anchors for rotator cuff repair
Experimental constructs failed by a variety of mechanisms, with the majority of all-suture anchors failing by anchor pull-out, whereby anchor integrity was maintained. This study compared the mechanical properties of currently marketed commercial all-suture anchors, using a biologically representative ex vivo model, with a traditional bone anchor comparator.
The study found that the load-to-failure was lower and displacement was significantly greater in some all-suture anchors compared with a control traditional anchor. These findings are consistent with previously published literature in non-human specimens. Although we discuss here load-to-failure and displacement as important mechanical characteristics to define the properties of anchors, these in themselves may be too simplistic to determine the value of implants for RC repair.
Due to their smaller size, a greater number of all-suture anchors can be placed in the same area of bone, allowing for greater strength of fixation and decreased gap formation.
Despite this, recent work from Pfeiffer et al 9 suggests that, within a canine model, an all-suture anchors promote cavity formation secondary to foreign-body reaction, with resulting expansion of the initial drill tunnel. On the other hand, traditional anchors were found to maintain the initial drill tunnel size.
The relative bio-incompatibility of all-suture anchors could predicate weaker load-to-failure values after long-term implantation. However, this concept requires further study. Generally speaking, the findings reported in this study are consistent with those reported in the literature. Ultimately, all anchors aim for minimum gap formation and maximum tensile strength. The maximum pull-out strength values reported are comparable with those of previous studies which have performed similar tests using all-suture anchors, with slight variations in materials and methodology.
In a bovine humeral model, Galland et al 6 found that although traditional anchors had higher mean tensile strength and lower elongation values at failure, there was no statistical difference between those and all-suture anchors.
These findings are echoed by Mazzocca et al 18 who found, in a glenoid labral repair model in human bone, that no difference could be demonstrated in ultimate load to failure and displacement at ultimate failure anchor pull-out between the all-suture and traditional anchors, despite greater mean values in the former group They also found that traditional anchors required significantly higher loads to achieve 2 mm of labral displacement than did all-suture anchors Of note, the anchors in the current study had a variety of failure mechanisms, typifying the difference in construction between all-suture and traditional anchors Table I.
This is in contrast to the traditional anchors, which failed by a combination of suture failure, anchor pull-out or eyelet breaking, consistent with what has been previously reported. With regard to gap formation of the construct, we found that the plastic control anchor had a mean total displacement of Furthermore, in a complete human cadaveric RC repair model, a standard single-row metal anchor repair demonstrated up to 7.
Although translation to clinical performance should be managed cautiously, displacement is considered a surrogate for in vivo gap formation post-implant and this could indicate greater instability in the post-operative patient rehabilitation process compared with traditional anchors.
Our study showed greater than previously reported gap formation, and this is likely to be due to the specific experimental set up, though it should be noted that the consistency of the construct design and experimental procedures facilitated comparisons of gap formation in implants tested.
Reported displacement in our paper, as in previous studies, is not constrained to movement of the anchor underneath the cortex, but of the whole construct, including the suture material, slippage in the suture grip, and the movement of the bone within the platform although this was minimal. The group found that by studying initial extension and creep static and dynamic as surrogates for initial and time-dependent gap formation, in addition to other mechanical parameters such as stiffness of the sutures, more appropriate determinants of suture performance could be measured.
In another study, an in vivo canine model developed by Pfeiffer et al 9 compared all-suture with traditional anchors and their findings corroborated with those of this study, reporting that all-suture anchors undergo greater displacement during cyclical loading at ultimate load mean We argue that displacement as measured within the whole system is a relevant measure because it is representative of gap formation, which is observed in the tissue-anchor construct in vivodespite the fact that the displacement value does not solely reflect subcortical displacement.