Background

While total shoulder arthroplasty (TSA) is a generally successful procedure, glenoid loosening remains a common complication. Though the occurrence of loosening was related to patient-specific factors, biomechanical factors related to implant features may also affect the fixation of the glenoid component, in particular increased glenohumeral mismatch that could result in eccentric loads and translations. In this study, a novel test setup was used to quantify glenohumeral pressures for different motion patterns after TSA.

Introduction

Glenoid loosening, still a main complication for shoulder arthroplasty, was suggested to be related implant design, surgical aspects, and also bone quality. However, typical studies of fixation do not account for heterogeneity in bone morphology and density which were suggested to affect fixation failure. In this study, a combination of cyclic rocking horse tests on cadaver specimens and microCT-based finite element (microFE) analysis of specimens of a wide range of bone density were used to evaluate the effects of periprosthetic bone quality on the risks of loosening of anatomical keeled or pegged glenoid implants.

Treatment of massive rotator cuff tears can be challenging. Previous studies with irreparable rotator cuff tears showed good clinical results of tendon healing with the arthroscopic insertion of a protective biodegradable spacer balloon filled with saline solution between the repaired tendon and the acromion [1,2], but so far no scientific evidence has showed how the device alters pressures over the repaired tendon. This biomechanical study investigated the effects of a spacer inserted in the subacromial space on pressures over the repaired rotator cuff tendon in passive motion cycles typical for post-operative rehabilitation routines.

Six human cadaveric shoulders were prepared with the humerus cut 15cm below the joint and embedded in a pot, while the scapula fixed at three points on a plate. A rotator cuff tear was simulated and repaired using a suture anchor and a Mason-Allen suture. The specimens were then mounted on a custom-made pneumatic testing rig to induce passive motion cycles of adduction-abduction (90–0°) and flexion-extension (0–40°) with constant glenohumeral and superior loads and tension is exerted on the supraspinatus tendon with weights. A pressure sensor was placed between the supraspinatus tendon and the acromion. After pressure measurements for 15 cycles of each motion type, the InSpace balloon (OrthoSpace, Inc, Israel) was inserted and the specimens tested and pressure measured again for 15 cycles. Statistically significant changes in peak pressures were then measured before and after balloon.

Peak pressures were measured near 90 degrees abduction. No statistical differences were observed for internal-external rotation before and after balloon-shaped subacromial spacer was inserted. Mean pressures in abduction-adduction were significantly reduced from 121.7 ± 9.5 MPa to 51.5 ± 1.2 MPa. Peak pressures after repair were 1171.3 ± 99.5 MPa and 1749.6 ± 80.7 MPa in flexion-extension and abduction-adduction motion, respectively, and significantly decreased to 468.7 ± 16.0 MPa and 535.1 ± 27.6 MPa after spacer insertion (p<0.0001).

The use of the spacer above the repaired tendon reduced peak pressures and distributed them more widely over the sensor during both abduction-adduction and flexion-extension motions and therefore can reduce the stress on the rotator cuff repair. The InSpace system may reduce the pressure on the repaired tendon, thus potentially protecting the repair. Further studies to investigate this phenomenon are warranted, in particular relating these changes to shoulder kinematics following tear repair and spacer insertion.

Introduction

Glenoid loosening, still a main complication in shoulder arthroplasty, could be related to glenohumeral orientation and conformity, cementing techniques, fixation design and periprosthetic bone quality [1,2]. While past numerical analyses were conducted to understand the relative role of these factors, so far none used realistic representations of bone microstructure, which has an impact on structural bone properties [3]. This study aims at using refined microFE models including accurate cortical bone geometry and internal porosity, to evaluate the effects of fixation design, glenohumeral conformity, and bone quality on internal bone tissue and cement stresses under physiological and pathological loads.

Objectives: The aim of this study was a clinical and radiological evaluation of 68 shoulders operated with the Delta reverse-ball-and-socket total shoulder prosthesis by the senior author with a mean follow-up of 42 months.

Methods: This is a retrospective study in one consecutive series of 68 shoulders, operated by the senior author, which were clinically assessed using the Constant score for pain, Constant Shoulder Score, Oxford Shoulder Score, UCLA Shoulder rating scale, DASH Score, Rowe Score for Instability and Oxford Instability Score. Radiological evaluation was graded by the classification according to Nerot et al. and complications were analysed according to Goslings and Gouma. Patients were evaluated before surgery and at a mean clinical follow-up of 42 months.

Results: There was a significant improvement in all clinical and stability scores. On the average, the Constant score for pain increased from 4.62 to 11.08 points (p< 0.05); the Constant Shoulder Score from 32.65 to 60.31 (p> 0.05); the Oxford Shoulder Score increased from 32.65 to 60.31 (p< 0.05) and the UCLA Shoulder rating scale increased from 15.08 to 27.42 (p< 0.05). The evaluation of stability showed an increase from 49.42 to 80.19 points in the Rowe Score for Instability and from 22.04 to 37.62 in the Oxford Instability score (p< 0.05). According to the Nerot classification, 65 percent of patients were graded as “0”, 20 percent as “1”, 3 percent as “2”, 6 percent as “3” and 6 percent as “4”. Eight complications occurred in terms of a nerve lesion which was graded according to Goslings and Gouma as “1” once, loosening of the humeral stem which was graded as “2” three times and loosening or fracture of the glenoid component which was graded as “2” in five times. At mean follow-up of 42 months, one patient of this series had died of decrepitude which was graded as “4” and one patient was lost of follow-up.

Conclusions: We summarize, that there were significant advantages identified in terms of the Constant score for pain, all clinical scores and the instability scores. Radiological analyses showed 85 percent of patients without or with a small notch only. On the other hand, the rate of complications should be taken into account. We conclude that shoulder arthroplasty with the Delta prosthesis shows significant benefits in terms of less shoulder pain, a higher stability and a gain of range of motion but on the other hand, we emphasize that this treatment remains a salvage procedure in the elderly only.

In recent years UHMWP sutures have gained more and more popularity in shoulder surgery. They have an increased tensile strength but were shown to have a higher rate of knot slippage due to their smooth surface. There exist different testing protocols on suture testing in dry or in wet conditions.

The purpose of this study was to gain some inside as to whether or not the knot security of sliding and non-sliding knots with different suture materials is influenced by dry or wet testing conditions.

We tested five common suture materials, all of them USP #2. The PDSII, the Ethibond and three ultra high molecular weight polyethylene (UHMWPE) sutures: Fiber Wire, Orthocord and Herculine. As non-sliding knots we used Square knot and Revo knot and for sliding knots we used Fisherman and Roeder knot. 10 samples of each knot type were tested. In the first group knot tying and biomechanical testing were performed under dry conditions. In the second group the sutures were soaked in saline solution for 3 min. before knot tying and afterwards tested in saline bath. Cyclic loading was performed to simulate the physiological conditions. We started with a tensile load of 25 N. After 100 cycles, the load was increased to 50 N for another 100 cycles. Until suture rupture or knot slippage of 3 mm the tensile load was gradually increased by 25 N per 100 cycles. Under dry conditions 170 suture ruptures and 30 knot slippages were recorded. Under wet testing conditions 186 suture ruptures and 14 knot slippages were seen, which tested statistically significant. Failure by knot slippage (n=44) was seen under dry and saline testing conditions mainly with UHMWPE sutures particularly with Herculine suture. Knot slippage occured only with sliding knots. With the Ethibond suture no knot slippage was found regardless of the testing conditions and applied knot type. Across all knot types the UHMPE-sutures were significantly stronger in ultimate load to failure than Ethibond and PDSII under dry and wet testing conditions.

Is the information we get from testing dry suture material reliable and helpful for our daily practice? Our study clearly showed: No! The mode of failure and the number of knot-failure differs significantly in wet testing conditions compared to dry testing. We found that the number of knot-failures is higher when tested with dry sutures than in wet testing conditions. The soaking of the suture material with fluid improves its “skid-resistance”. As we expected showed the UHMWP sutures with their smooth surface a high number of knot-failures compared to polyethylen suture Ethibond, which did not show a single knot-failure in dry or wet tesing conditions. The maximum failure load showed clearly the superiority of the new UHMWP suture material, with around 300 N being double as high as for polyethylen and polydioxone sutures.

The incidence of rotator cuff tears increases with age, thus the rotator cuff tear is often associated with osteoporotic or osteopenic bone in the proximal humerus, especially with female patients. For testing of fixation devices such as suture anchors used in rotator cuff repair often animal bones are used. They are easily to obtain, inexpensive and some have been found to be similar to human bone. But can we rely on the results drawn from these studies in our daily surgical practice?

The purpose of this study was to compare the trabecular bone mineral density, the trabecular bone volume fraction and the cortical layer thicknes in the greater tubercle in different species to evaluate their infiuence on primary stability of suture anchors under a cyclic loading protocol representing the physiologic forces placed on rotator cuff repairs in vivo. We hypothezised that maximum pullout forces as well as the modes of failure are different for a suture anchors in different humeri. The available three different types of anchor fixation design (screw: Spiralok 5mm, Super Revo 5mm, press-fit: Bioknotless RC, wedging: Ultrasorb) were tested. The bone mineral density (BMD) of the humeri was measured by a 64-slice-computed tomography system. Each anchor was tested individually until failure. The sutures were pulled at 135° to the axis of the humeral shaft, simulating the physiological pull of the supraspinatus tendon. Starting with 75 N the tensile load was gradually increased by 25 N after everey 50 cycles until failure of the anchor fixation system occurred. The ultimate failure load, the system displacement after the first pull with 75 N and the mode of failure were recorded.

The ultimate failure loads of each anchor were different in the human osteopenic, human healthy, ovine and bovine humeri. The statistical significancies for pull out forces between the anchors varied from species to species. The biomechanical testing of suture anchors for arthroscopic rotator cuff repair in ovine and bovine humeri does not give reliable data that can be transferred to the human situation. The significances between the suture anchors found in ovine and bovine humeri are different from the results in human humeri. When taking the impaired bone quality of older patients into account the results from ovine and bovine humeri are even less predictable. We found a positive correlation between maximum failure load and cortical layer thickness for the Super Revo and the Ultrasorb anchor. The ultimate failure load seems to depend mainly on the cortical thickness and on the subcortical trabecular bone quality.

Introduction: Knotless Suture Anchors provide numerous advantages in arthroscopic rotator-cuff (RC) repair such as, reducing the difficulties of knot tying, reducing surgical exposure, thus decreasing morbidity. The purpose of this in-vitro study was to compare the pull-out strength of three new knotless suture anchors in correlation with bone quality using the following anchors: Opus Magnum 2 -ArthroCare Co., USA; Push Lock and Swivel Lock -Arthrex Inc., USA.

Material & Methods: Ten healthy and ten osteopenic macroscopically intact humeri with an average age of 51.7 and 79.5 years, respectively, were loaded with the three knotless suture anchors according to the manufacturers’ description. The healthy humeri had a mean trabecular BMD of 152.77 mgCa-HA/ml. The osteopenic humeri had a mean trabecular bone mineral density of 54.02 mgCa-HA/ml. The humeri were positioned in a custom - engineered adjustable fixation device, stabilising the direction of the pull of the sutures at an angle of 135° to the axis of the humeral shaft (Universal testing device Z010/TN2A – Zwick GmbH, Ulm, Germany). The anchors were cyclically loaded to simulate postoperative conditions.

The ultimate pull-out strenngth, the initial displacement in millimeters after the first pull with 75 N and the modes of failure were recorded.

Results: The mean ultimate failure loads of the Opus Magnum 2, PushLock and SwiveLock anchors in osteopenic humeri were 135.0, 102.5 and 130.0 N (p> 0.05), respectively, and in healthy humeri 142.5 N, 182.5 N and 202.5 N (p> 0.05), respectively. The initial system displacement in osteopenic humeri of the Opus Magnum 2, PushLock and SwiveLock anchors were 3.53 mm, 16.11 mm and 3.23 mm (p< 0.01), respectively, and in healthy humeri 3.71 mm, 1.98 mm, and 1.96 mm (p> 0.05), respectively.

Discussion: The results of this study show that in osteopenic humeri, the Opus Magnum 2 and SwiveLock anchors display significant superiority in system displacement with an initial pull of 75N compared to the PushLock anchor in osteopenic bone, but all three anchors fail to provide significance in the ultimate failure load. PushLock anchor might cause a greater gap formation between the RC-tendon and greater tubercle interface in osteopenic humeri due to inferior gripping and therefore should not be used solely for RC repair. Due to a manufacturing flaw the suture holding fixture of the Opus Magnum 2 anchor “breaks” when a mean force of 138.75 N is applied to the system, regardless of the bone quality, thus disabling the anchor to unfold it’s properties in healthy bone. Whereas the results in osteopenic bone are comparable to the other two anchors. SwiveLock provides the best support of all three anchors in healthy humeri.

Aim: Retears after rotator cuff surgery occur frequently and may compromise the functional results. Failure of bone anchors and sutures may influence the results to a great part. The goals of this in vitro investigation were to determine the mechanical strength and stiffness of different bone anchors frequently used in arthroscopic rotator cuff surgery. Focus was put a material and design of the anchors.

Material und Methods: Four bone anchors were tested, each standing for a specific group of bone anchor. The metallic Super Revo screw 5.0 (Linvatec), the absorbable screw Spiralok 5.0 (Mitek), the absorbable press-fit anchor Bioknotless RC (Mitek) and the absorbable Ultra-sorb RC (Linvatec). The anchors were tested on 12 pairs of fresh-frozen human shoulders. The mean age at the time of death was fifty-seven years (range 27–93 yrs.).

Cyclic loading was performed, as it was considered the best way to simulate the postoperative conditions. The maximum tensile strength, the failure mode, and the displacement of the fixation device (system displacement) under load at the first cycle of 75 N and at the maximum tensile strength were recorded.

Results: As reported before the most frequent failure mode for the titan anchor Super Revo 5 mm was a rupture of the threads at the eyelet.

The absorbable Spiralok 5 mm screw anchor showed the highest failure load with a mean of 223 N. The failure loads of the remaining anchors were similar and ranged from a mean of 169 N for the Super Revo 5 mm, over a mean of 173 N for the Ultrasorb RC anchor to a mean of 188 N for the Bioknotless anchor. Among these anchors the differences were not significant. Only the Spiralok 5 mm screw showed a significantly higher failure load when compared with the Super Revo 5 mm screw.

The displacement of the various systems showed significant differences. The displacement of the Bioknotless anchor showed after the cycle with a tensile strength of 75 N a mean displacement of 13.8 mm, which was significant when compared with the remaining anchors.

Discussion: Our study shows that there is no advantage in using titan anchors with regards to primary stability in arthroscopic rotator cuff repair. We could even detect a significantly higher failure load for the absorbable Spiralok 5 mm screw anchor compared to the Super Revo 5 mm titan screw. Stability and system displacement depend not only on the anchor material but on the design of the anchor. We found that the absorbable Bioknotless RC anchor showed a significantly higher system displacement during the first cyclic loading (75 N) while all other anchors tested had a similar system displacement.

Aim: The aim of the study was to investigate the influence of bone density of the greater tuberosity on mechanical strength of different bone anchors for rotator cuff surgery. Especially in osteopenic bone the metal bone anchors and transosseus sutures are still the “gold-standard” in rotator cuff surgery.

Material and Methods: Four bone anchors, each standing for a specific group of bone anchor, and two suture materials were tested. One of them was the metallic Super Revo screw 5.0 (Linvatec), the absorbable screw Spiralok 5.0 (Mitek), the absorbable press-fit anchor Bioknotless RC (Mitek) and the absorbable Ultrasorb RC (Linvatec). The suture materials tested was the well known V-37 (Ethicon) and the new Orthocord (Mitek) both USP 2. All fixations systems were tested on a) 6 pairs of fresh-frozen human shoulders from young adults (range 20–50 yrs.) and b) 6 pairs of fresh frozen human shoulders from elderly (range 60–93 yrs.). Cyclic loading was performed, as it was considered the best way to simulate the postoperative conditions in a manner similar to those used in prior studies until the system failed. The maximum tensile strength, the failure mode, and the displacement of the fixation device (system displacement) under load at the first cycle at 75 N and at the maximum tensile strength were recorded.

Results: The absorbable Spiralok 5 mm screw anchor showed the highest failure load with a mean of 171 N in osteopenic bone. The suture material Orthocord and V-37 had the lowest mechanical strength in osteopenic bone with a mean of 125 N resp. 114 N. The remaining anchors had an almost identical failure load with means of 150 N (Super Revo 5 mm and Bioknotless RC) and 151 N (Ultrasorb RC). No statistical significance was found though. Comparing the mechanical strength of each fixation system in healthy and osteopenic bone no statistical significant difference was found except for the V-37 suture. In healthy bone the failure load of V-37 suture had a mean of 204 N and in osteopenic bone of 114 N.

Discussion: The absorbable Spiralok 5 mm screw showed a good performance in healthy and osteopenic bone when compared with standard bone anchor like the titan Super Revo 5 mm screw or transosseous sutures. Absorbable anchors have certain advantages, besides that usually they are more expensive. They can easily be overdrilled in case of rupture of the suture material, and they do not interfere during later revision surgery or for imaging studies such as magnetic resonance imaging.