Ryan Milks

Primary pedicle screw augmentation in osteoporotic lumbar vertebrae: biomechanical analysis of pedicle fixation strength.

Study Design. Pedicle screw pullout testing in osteoporotic and control human cadaveric vertebrae, comparing augmented and control vertebrae. Objective. To compare the pullout strengths of pedicle screws fixed in osteoporotic vertebrae using polymethyl methacrylate delivered by 2 augmentation techniques, a standard transpedicular approach and kyphoplasty type approach. Summary of Background Data. Pedicle screw instrumentation of the osteoporotic spine carries an increased risk of screw loosening, pullout, and fixation failure. Osteoporosis is often cited as a contraindication for pedicle screw fixation. Augmentation of the vertebral pedicle and body using polymethyl methacrylate may improve fixation strength and construct survival in the osteoporotic vertebrae. While the utility of polymethyl methacrylate has been demonstrated for salvage of screws that have been pulled out, the effect of the cement technique on pullout strength in osteoporotic vertebrae has not been previously studied. Methods. Thirteen osteoporotic and 9 healthy human lumbar vertebrae were tested. All specimens were instrumented with pedicle screws using a uniform technique. Osteoporotic pedicles were augmented with polymethyl methacrylate using either a kyphoplasty type technique or a transpedicular augmentation technique. Screws were tested in a paired testing array, randomly assigning the augmentation techniques to opposite sides of each vertebra. Pullout to failure was performed either primarily or after a 5000-cycle tangential fatigue conditioning exposure. After testing, following screw removal, specimens were cut in the axial plane through the center of the vertebral body to inspect the cement distribution. Results. Pedicle screws placed in osteoporotic vertebrae had higher pullout loads when augmented with the kyphoplasty technique compared to transpedicular augmentation (1414 ± 338 versus 756 ± 300 N, respectively; P < 0.001). An unpaired t test showed that fatigued pedicle screws in osteoporotic vertebrae augmented by kyphoplasty showed higher pullout resistance than those placed in healthy control vertebrae (P = 0.002). Both kyphoplasty type augmentation (P = 0.007) and transpedicular augmentation (P = 0.02) increased pullout loads compared to pedicle screws placed in nonaugmented osteoporotic vertebrae when tested after fatigue cycling. Conclusions. Pedicle screw augmentation with polymethyl methacrylate improves the initial fixation strength and fatigue strength of instrumentation in osteoporotic vertebrae. Pedicle screws augmented using the kyphoplasty technique had significantly greater pullout strength than those augmented with transpedicular augmentation technique and those placed in healthy control vertebrae with no augmentation.

Rotator cuff repair augmentation in a canine model with use of a woven poly-L-lactide device.

BACKGROUND Despite advances in surgical treatment options, failure rates of rotator cuff repair have continued to range from 20% to 90%. Hence, there is a need for new repair strategies that provide effective mechanical reinforcement of rotator cuff repair as well as stimulate and enhance the intrinsic healing potential of the patient. The purpose of this study was to evaluate the extent to which augmentation of acute repair of rotator cuff tendons with a newly designed poly-L-lactide repair device would improve functional and biomechanical outcomes in a canine model. METHODS Eight adult, male mongrel dogs (25 to 30 kg) underwent bilateral shoulder surgery. One shoulder underwent tendon release and repair only, and the other was subjected to release and repair followed by augmentation with the repair device. At twelve weeks, tendon retraction, cross-sectional area, stiffness, and ultimate load of the repair site were measured. Augmented repairs underwent histologic assessment of biocompatibility. In addition, eight pairs of canine cadaver shoulders underwent infraspinatus injury and repair with and without device augmentation with use of identical surgical procedures and served as time-zero biomechanical controls. Eight unpaired, canine cadaver shoulders were included as normal biomechanical controls. RESULTS At time zero, repair augmentation significantly increased the ultimate load (23%) (p = 0.034) but not the stiffness of the canine infraspinatus tendon repair. At twelve weeks, the poly-L-lactide scaffold was observed to be histologically biocompatible, and augmented repairs demonstrated significantly less tendon retraction (p = 0.008) and significantly greater cross-sectional area (137%), stiffness (26%), and ultimate load (35%) than did repairs that had not been augmented (p < 0.001, p = 0.002, and p = 0.009, respectively). CONCLUSIONS While limiting but not eliminating tendon repair retraction, the augmentation device provided a tendon-bone bridge and scaffold for host tissue deposition and ingrowth, resulting in improved biomechanical function of the repair at twelve weeks.

Improved time-zero biomechanical properties using poly-L-lactic acid graft augmentation in a cadaveric rotator cuff repair model

HYPOTHESIS Rotator cuff repair failure rates range from 20% to 90%, and failure is believed to occur most commonly by sutures cutting through the tendon due to excessive tension at the repair site. This study was designed to determine whether application of a woven poly-L-lactic acid device (X-Repair; Synthasome, San Diego, CA) would improve the mechanical properties of rotator cuff repair in vitro. MATERIALS AND METHODS Eight pairs of human cadaveric shoulders were used to test augmented and non-augmented rotator cuff repairs. Initial stiffness, yield load, ultimate load, and failure mode were compared. RESULTS Yield load was 56% to 92% higher and ultimate load was 56% to 76% higher in augmented repairs. No increase in initial stiffness was found. Failure by sutures cutting through the tendon was reduced, occurring in 17 of 20 non-augmented repairs but only 7 of 20 augmented repairs. CONCLUSIONS Our data show that application of the X-Repair device significantly increased the yield load and ultimate load of rotator cuff repairs in a human cadaveric model and altered the failure mode but did not affect initial repair stiffness.

Reinforced fascia patch limits cyclic gapping of rotator cuff repairs in a human cadaveric model

BACKGROUND Scaffolds continue to be developed and used for rotator cuff repair augmentation, but clinical or biomechanical data to inform their use are limited. We have developed a reinforced fascia lata patch with mechanical properties to meet the needs of musculoskeletal applications. The objective of this study was to assess the extent to which augmentation of a primary human rotator cuff repair with the reinforced fascia patch can reduce gap formation during in vitro cyclic loading. MATERIALS AND METHODS Nine paired human cadaveric shoulders were used to investigate the cyclic gap formation and failure properties of augmented and non-augmented rotator cuff repairs with loading of 5 to 180 N for 1000 cycles. RESULTS Augmentation significantly decreased the amount of gap formation at cycles 1, 10, 100, and 1000 compared with non-augmented repairs (P < .01). The mean gap formation of the augmented repairs was 1.8 mm after the first cycle of pull (vs 3.6 mm for non-augmented repairs) and remained less than 5 mm after 1000 cycles of loading (4.7 mm for augmented repairs vs 7.3 mm for non-augmented repairs). Furthermore, all augmented repairs were able to complete the 1000-cycle loading protocol, whereas 3 of 9 non-augmented repairs failed before completing 1000 loading cycles. CONCLUSIONS This study supports further investigation of reinforced fascia patches to provide mechanical augmentation, minimize tendon retraction, and possibly reduce the incidence of rotator cuff repair failure. Future investigation in animal and human studies will be necessary to fully define the efficacy of the reinforced fascia device in a biologic healing environment.

Adjacent level load transfer following vertebral augmentation in the cadaveric spine.

Study Design. In vitro biomechanics. Objective. To determine if osteoporotic vertebral compression fracture (VCF) augmentation increases adjacent level load transfer. Summary of Background Data. Osteoporotic VCF subsequent to augmentation may result from disease progression or increased adjacent level load transfer, or both. Methods. There were 11 T3–T7 and 10 T8–T12 divided by lumbar bone mineral density into a normal group (No. 1; n = 11) and an osteoporotic group (No. 2; n = 10). Strain and centrum stress were measured on T4 and T6 (T3–T7), and T9 and T11 (T8–T12) during tests in the intact state, following a centrum defect, during and after an augmented VCF at T5 or T10, and during a subsequent VCF. Stiffness and strength were compared: between groups 1 and 2; among intact, defect, and augmented VCF states; and between the initial and subsequent VCF. Results. Group 1 was stiffer than 2 in compression (P = 0.01) and flexion (P = 0.07), with no difference in adjacent level load transfer (strain P = 0.72, centrum stress P = 0.36) or strength (P = 0.07). The centrum defect reduced compressive stiffness from the intact (P = 0.001), which was partially restored following VCF augmentation (P = 0.006). There were no differences in flexion stiffness (P ≥ 0.14). Adjacent level load transfer in flexion exceeded that in compression (strain P = 0.001, centrum stress P = 0.19). Initial and subsequent VCF occurred at similar forces (P = 0.26) with higher adjacent level load at subsequent (strain and centrum stress P = 0.04). Conclusions. Augmentation of multilevel spinal segments with VCF produced by combined compression, flexion, and a centrum defect normalizes adjacent level load transfer at physiologic loads. In both normal and osteoporotic spinal segments, as loads approach those of the initial VCF, protection from augmentation is lost, and subsequent adjacent level VCFs occur from extreme loading, and not the augmentation process.

The mechanics of polymethylmethacrylate augmentation.

Osteoporosis frequently leads to vertebral compression fractures. Percutaneous cement augmentation, one recent technique, may alter the biomechanics of the vertebral body and spinal segment. These alterations reportedly predispose the spinal segment to additional vertebral compression fractures. We investigated the changes in segment stiffness and strength after polymethylmethacrylate augmentation. Twelve thoracic segments consisting of five vertebral bodies were divided into two groups, a pure moment group (Group 1) and an eccentric compression group (Group 2). Baseline measurements of stiffness were taken on each segment followed by the creation of an initial vertebral compression fracture during which stiffness and strength were measured. After augmentation, stiffness was again measured. Finally, a second vertebral compression fracture was created measuring stiffness and strength again. Augmentation did not alter stiffness before and after augmentation in either group. Augmentation also did not result in any difference in strength measured at subsequent fracture when compared with strength measured at initial fracture in either group. The augmentation of vertebral compression fractures by kyphoplasty does not alter the stiffness or the strength of the multilevel segments and eccentric compression in contrast to pure moments leads to a lower strength during mechanical testing.

A preliminary biomechanical evaluation in a simulated spinal fusion model: Laboratory investigation

OBJECT A preliminary in vitro biomechanical study was conducted to determine if the pressure at a bone graft-mortise interface and the load transmitted along a ventral cervical plate could be used as parameters to assess fusion status. METHODS An interbody bone graft and a ventral plate were placed at the C3-4 motion segment in six fresh cadaveric goat spines. Polymethylmethacrylate (PMMA) was used to simulate early bone fusion at the bone graft site. The loads along the plate and the simultaneous pressures induced at the graft-endplate interfaces were monitored during simulated stages of bone healing. Each specimen was nondestructively tested in compression loading while the pressures and loads at the graft site were recorded continuously. Each specimen was tested under five conditions (Disc, Graft, Plate, PMMA, and Removal). RESULTS The pressure at the interface of the bone graft and vertebral endplate did not change significantly with the addition of the ventral plate. The interface pressure and segmental stiffness did increase following PMMA augmentation of the bone graft (simulating an intermediate phase of bone fusion). The load transmitted along the ventral plate in compression increased after the addition of the bone graft, but decreased after PMMA augmentation. Thus, there was an increase in pressure at the graft-endplate interface and a decrease in load transferred along the ventral plate after the simulation of bone fusion. Upon removal of the ventral plate, the simulated fusion bore most of the axial load, thus explaining a further increase in graft site pressure. CONCLUSIONS These observations support the notions of load sharing and the redistribution of loads occurring during and after bone graft incorporation. In the clinical setting, these parameters may be useful in the assessment of fusion after spine surgery. Although feasibility has been demonstrated in this preliminary study, further research is needed.

Biomechanical characteristics of hybrid hook-screw constructs in short-segment thoracic fixation.

Study Design. Ex vivo biomechanical testing of human cadaveric thoracic spine segments. Objective. To determine whether a hybrid construct, using a combination of pedicle screws (PSs) and lamina hooks, was equivalent to a PS construct, in a short-segment thoracic spine fixation model. Summary of Background Data. Comparisons have been made among PS, lamina hook, and hybrid screw-hook constructs, but these have generally been in long-segment scoliosis correction. In this study, we compared the hybrid and screw-only constructs in a short-segment thoracic fixation. Methods. For pullout testing, matched specimens were used for PS (n = 8) and hybrid (n = 8) constructs. Construct stiffness, and the force required for construct failure, were measured. Dynamic testing was carried out on specimens in the PS (n = 7) and hybrid (n = 7) groups in compression, flexion, extension, and left and right lateral bending. Each group was tested intact, after instrumentation, and after corpectomy. Results. When compared with the hybrid group, a significantly greater force was required for construct failure in the PS group, and these PS constructs were significantly stiffer. No differences were found between groups in dynamic testing. Conclusion. A construct employing PSs is significantly stiffer and more resistant to pullout failure than a hook-screw hybrid construct.

Low-dose CT imaging of radio-opaque markers for assessing human rotator cuff repair: Accuracy, repeatability and the effect of arm position

Previous studies have used radiostereometric analysis (RSA) to assess the integrity and mechanical properties of repaired tendons and ligament grafts. A conceptually similar approach is to use CT imaging to measure the 3D position and distance between implanted markers. The purpose of this study was to quantify the accuracy and repeatability of measuring the position and distance between metallic markers placed in the rotator cuff using low-dose CT imaging. We also investigated the effect of repeated or variable positions of the arm on position and distance measures. Six human patients had undergone rotator cuff repair and placement of tantalum beads in the rotator cuff at least one year prior to participating in this study. On a single day each patient underwent nine low-dose CT scans in seven unique arm positions. CT scans were analyzed to assess bias, precision and RMS error of the measurement technique. The effect of repeated or variable positions of the arm on the 3D position of the beads and the distance between these beads and suture anchors in the humeral head were also assessed. Results showed the CT imaging method is accurate and repeatable to within 0.7 mm. Further, measures of bead position and anchor-to-bead distance are influenced by arm position and location of the bead within the rotator cuff. Beads located in the posterior rotator cuff moved medially as much as 20 mm in abduction or external rotation. When clinically relevant CT arm positions such as the hand on umbilicus or at side were repeated, bead position varied less than 4 mm in any anatomic direction and anchor-to-bead distance varied +2.8 to -1.6 mm (RMS 1.3 mm). We conclude that a range of ± 3 mm is a conservative estimate of the uncertainty in anchor-to-bead distance for patients repeatedly scanned in clinically-relevant arm positions.

Bone Graft Substitute Provides Metaphyseal Fixation for a Stemless Humeral Implant

Stemless humeral fixation has become an alternative to traditional total shoulder arthroplasty, but metaphyseal fixation may be compromised by the quality of the trabecular bone that diminishes with age and disease, and augmentation of the fixation may be desirable. The authors hypothesized that a bone graft substitute (BGS) could achieve initial fixation comparable to polymethylmethacrylate (PMMA) bone cement. Fifteen fresh-frozen human male humerii were randomly implanted using a stemless humeral prosthesis, and metaphyseal fixation was augmented with either high-viscosity PMMA bone cement (PMMA group) or a magnesium-based injectable BGS (OsteoCrete; Bone Solutions Inc, Dallas, Texas) (OC group). Both groups were compared with a control group with no augmentation. Initial stiffness, failure load, failure displacement, failure cycle, and total work were compared among groups. The PMMA and OC groups showed markedly higher failure loads, failure displacements, and failure cycles than the control group (P<.01). There were no statistically significant differences in initial stiffness, failure load, failure displacement, failure cycle, or total work between the PMMA and OC groups. The biomechanical properties of magnesium-based BGS fixation compared favorably with PMMA bone cement in the fixation of stemless humeral prostheses and may provide sufficient initial fixation for this clinical application. Future work will investigate the long-term remodeling characteristics and bone quality at the prosthetic-bone interface in an in vivo model to evaluate the clinical efficacy of this approach.