Abstract
Purpose
Tension band wiring (TBW) is considered the ‘gold standard’ for fixation of transverse olecranon fractures (OTA/AO 2U1B1d). However, this approach requires a large exposure, can be technically demanding and operator-dependent, and is associated with hardware prominence. Continuous compression implants (CCI) may address these limitations. To the authors' knowledge, a comparison between TBW and CCI has not been performed. Therefore, this study was designed to compare biomechanical properties of CCI to TBW for 2U1B1d olecranon fractures using human cadaver elbows.
Methods
A transverse olecranon fracture was simulated in eight matched pairs of cadaveric elbows. Matched pairs were used for comparison of TBW and CCI. Cyclic loading was performed at both 10 N and 500 N, with gap formation and load to failure recorded. Results: No significant difference in gap formation at 10 N (p > 0.3) or 500 N (p = 0.6), or load-to-failure (p=.00.41), was observed between the two groups.
Discussion
CCI fixation requires a smaller incision, is easy to perform, and involves low-profile implant that may reduce morbidity. Based on biomechanical properties that match the gold standard, continuous compression nitinol implants are an appropriate option for fixation of transverse olecranon fractures with potential advantages over tension band wiring.
Keywords: Tension band wiring, Continuous compression implants, Olecranon fracture, Gold standard
1. Introduction
Olecranon fractures comprise 10–20% of all elbow fractures.1,2 The gold standard for operative fixation of transverse olecranon fractures is tension band fixation, which consistently yields adequate reduction and stability for satisfactory fracture healing.2 However, this method of fixation requires a relatively large surgical exposure, can be technically demanding and operator-dependent, and is associated with hardware prominence and irritation.3 Implant removal rate of 50% has been reported in TBW-treated patients.3,4 Subsequent procedures to remove hardware are associated with additional risks of morbidity, wound complications, and increased costs. Alternative methods of fixation, including circular wiring,5 figure-of-eight wiring, intramedullary screw with wire or suture,6 intramedullary nail,7 tension band with stainless steel noncompressive staples,8 cerclage cable, and plate fixation9 have been reported to be biomechanically equivalent or superior to tension band wiring (TBW) with potential advantages for fixation of simple transverse olecranon fractures.10 However, none of these methods consistently address the issues regarding surgical exposure, technical demands, and hardware irritation that are associated with complications, morbidity, and increased costs. As such, these issues remain as areas of unmet needs in orthopaedic surgery for the treatment of olecranon fractures.
Nitinol is an alloy of nickel and titanium that has both shape-memory and super-elastic properties that are useful for a number of surgical applications.11 Its elastics modulus is similar to bone, has excellent compressive strength, and maintains compression throughout fracture healing, all of which are important characteristics for orthopaedic applications.12 Utilizing the biomechanical properties of the nitinol alloy, medical device manufacturers have developed continuous compression implants (CCI) that provide a novel tool with potential advantages for indications traditionally addressed using lag screw technique, tension band wiring, and compression plating. CCIs have been successfully used for hindfoot13 and midfoot arthrodesis,14,15 scoliosis treatment,16 wrist arthrodesis,17 and fracture fixation of the patella,18 scaphoid,19 glenoid, pubic symphysis, and acetabulum.20 Importantly, CCI fixation requires a relatively small incision for implantation using a simple standardized technique, provides compression resistance to deformation under cyclical loading, and are low-profile. Therefore, if CCI fixation is associated with clinically relevant biomechanical properties that are similar to TBW for simple transverse olecranon fractures, this novel fixation method could address critical unmet needs in orthopaedic surgery by providing an effective treatment option that requires a smaller incision and shorter operative times and results in lower morbidity, complications, and costs.21 While biomechanical and animal model studies have been performed to assess CCI fixation for certain indications,22,23 no comparison of the biomechanical properties of CCI versus TBW for fixation of olecranon fractures is available, to the authors’ knowledge. Therefore, the present study was designed to compare the clinically relevant biomechanical properties of CCI to TBW for simple, transverse (AO/OTA 2U1B1d) olecranon fractures using human cadaver elbows in a robotic testing system. The hypothesis for the study was that the use of two CCIs in a human cadaver model of 2U1B1d fractures would provide statistically equivalent biomechanical properties when compared to the gold standard, TBW, during clinically relevant cyclic and load-to-failure testing.
2. Methods
In accordance with institutional review board (IRB) general policies and guidelines for use of human cadaveric specimens, 8 matched pairs of cadaveric elbows (n = 16; 10 M, 6F, mean age = 61 years; mean weight = 162 lbs) (ScienceCare) were prepared for testing by removing all periarticular soft tissues except for joint capsule, triceps tendon, medial collateral, lateral collateral, and annular ligaments. Specimens were thawed in a 37C incubator 24h prior to fixation. A 2U1B1d transverse olecranon fracture was simulated by a transverse osteotomy at the midpoint of the semilunar notch between the coronoid and olecranon process with use of a microsagittal saw and osteotome. A small capsulotomy was performed to visually assess for adequate reduction at the articular surface. Fracture reduction was achieved under direct visualization and maintained during fixation with pointed reduction clamps. Matched pairs of elbows were used for comparison of TBW versus CCI fixation, with alternation of fixation methods between left and right specimens. Specimens were then held in a 37C incubator after fixation until immediately before testing began.
2.1. Continuous compression implant technique (Fig. 1)
Fig. 1.
Continuous compression implants.
CCI fixation was performed utilizing two Elite Nitinol Memory Implants (DePuy Synthes, West Chester, PA) placed over the posterior olecranon at fracture site, spread approximately 1 cm apart or as far ulnar and radial as the specimen anatomy allowed, inserted according to manufacturer technique guide and specification. A 15 mm guide was used to drill pilot holes in appropriate positions in the proximal and distal cortices proximal and distal to the fracture site. Two 15 mm CCIs were placed across the fracture site by hand using the manufacturer's insertion tool, then final placement achieved using tamps to place implant flush with the outer cortex.
2.2. Tension band wiring technique (Fig. 2)
Fig. 2.
Tension band wiring.
Tension band wiring was performed according to AO technique. Two 0.062-in Kirschner wires were drilled obliquely through the olecranon and anchored in the anterior cortex of the ulna distal to the coronoid. A 2.0 mm bicortical hole was drilled transversely through the posterior ulna 4 cm distal to the osteotomy site. An 18-gauge wire was passed through the 2.0 mm hole and around the Kirschner wires to form a figure-of-eight and tensioned using the one-knot technique.
2.3. Biomechanical testing (Fig. 3)
Fig. 3.
Biomechanical testing.
Biomechanical testing was performed based on previously described protocols.24 Each elbow was fixed at 90° in a custom-designed positioning apparatus with the triceps tendon attached to the arm using a custom clamp to allow isometric loading of the elbow within the six degree-of-freedom (6DOF) robotic testing system (KR 300 R2500 Ultra; KUKA, Ausburg, Germany with SimVitro software, Cleveland Clinic, Cleveland, Ohio) with optical tracking system (Optotrak Certus; Northern Digital, Waterloo, Canada) (Fig. 3). The triceps tendon was cyclically loaded to simulate two clinically relevant conditions:
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500 sinusoidal cycles from 0 to 10 N for active postoperative range of motion, followed by
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500 sinusoidal cycles from 0 to 500 N to simulate repetitive pushing up from a chair
Fixed optical sensors were placed immediately proximal and distal to the fracture site to allow for continuous measurements of fracture displacement throughout testing (Fig. 4). Load (N)–displacement (mm) data were generated for each testing cycle, and was measured in the xyz coordinate system by calculating vector length between the two markers and comparing the lengths before and after loading. This method was selected to account for bending of the bone during 500 N testing. Failure was defined as >2 mm fracture distraction based on previous articular fracture research and biomechanical testing models.6,24 For specimens that completed cyclical testing without failure, single load-to-failure testing was performed in position-control mode. For specimens that failed (>2 mm fracture distraction) prior to completing testing, load-to-failure was determined from load-displacement curves using load at >2 mm for analysis.
Fig. 4.
Set up showing fixed optical sensors placed immediately proximal and distal to the fracture site to allow for continuous measurements of fracture displacement throughout testing.
Sample size (n = 16; 8 matched pairs) was determined based on a pre-study t-Test power analysis using previous and pilot data supporting an expected difference in means of 0.2 mm at 500 cycles, standard deviation of 0.2 mm, alpha = 0.05, and 1-beta = 0.8. Displacements, cycles-to-failure, and load-to-failure were determined for each elbow. Descriptive statistics were calculated to determine means and standard deviations. Data were compared for statistically significant differences between treatments using paired t-Tests for continuous data and Fisher's Exact Tests for number of specimens in each group that completed 500 N x 500 cycle testing with significance set at p < 0.05.
3. Results
Biomechanical testing data are provided in Table 1, and raw data can be found in Table 2. CCI and TBW fixation allowed for completion of 10 N x 500 cycle testing in all specimens with no significant (p > 0.3) differences in gap formation (all < 1 mm) at each 100-cycle interval. For 500 N testing, gap formation was not significantly (p = 0.6) different between CCI and TBW after 100 cycles. There was no significant (p = 0.99) difference in number of specimens in each group that completed 500 N x 500 cycle testing (4 CCI vs 5 TBW) and cycles to failure were also statistically (p = 0.28) similar between treatments. There were also no statistical (p = 0.41) differences in load-to-failure for CCI vs TBW.
Table 1.
Mean ± SD values for gap formation, cycles-to-failure, and load-to-failure results for cadaveric biomechanical testing of olecranon fracture repair.
| Treatment Cohort | Gap Formation (mm) during 10 N Cyclical Testing |
Gap Formation (mm) during 500 N Cyclical Testing (100 Cycles) | Cycles to Failure @ 500 N | Load to Failure (N) | ||||
|---|---|---|---|---|---|---|---|---|
| 100c | 200c | 300c | 400c | 500c | ||||
| CCI | 0.45 ± 0.06 | 0.5 ± 0.04 | 0.56 ± 0.04 | 0.6 ± 0.05 | 0.62 ± 0.04 | 1.2 ± 0.8 | 290 ± 83 | 510 ± 43 |
| TBW | 0.57 ± 0.04 | 0.6 ± 0.04 | 0.6 ± 0.05 | 0.76 ± 0.05 | 0.81 ± 0.06 | 1.6 ± 1 | 320 ± 75 | 560 ± 91 |
CCI = continuous compression implants; TBW = tension band wire; c = cycles; mm = millimeters; N = Newtons; Failure = >2 mm fracture displacement.
Table 2.
Raw testing data.
| 192163L | 192163R | C200417L | C200417R | C200663L | C200663R | F192116R | F192116L | F192171R | F192171L | C200828R | C200828L | C200850R | C200850L | C200872R | C200872L | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10N | ||||||||||||||||
| 100 Cycles | 0.08 | 0.05 | 0.07 | 0.05 | 0.03 | 0.04 | 0.02 | 0.03 | 0.06 | 0.06 | 0.06 | 0.05 | 0.07 | 0.16 | 0.07 | 0.02 |
| 200 Cycles | 0.1 | 0.05 | 0.06 | 0.05 | 0.04 | 0.06 | 0.02 | 0.03 | 0.05 | 0.06 | 0.08 | 0.07 | 0.07 | 0.16 | 0.07 | 0.03 |
| 300 Cycles | 0.1 | 0.08 | 0.06 | 0.05 | 0.05 | 0.07 | 0.03 | 0.04 | 0.06 | 0.05 | 0.08 | 0.08 | 0.06 | 0.16 | 0.06 | 0.03 |
| 400 Cycles | 0.12 | 0.08 | 0.06 | 0.06 | 0.06 | 0.1 | 0.03 | NA | 0.06 | 0.07 | 0.09 | 0.07 | 0.07 | 0.18 | 0.06 | 0.03 |
| 500 Cycles | 0.15 | 0.09 | 0.06 | 0.06 | 0.06 | 0.11 | 0.03 | NA | 0.06 | 0.07 | 0.1 | 0.08 | 0.07 | 0.17 | 0.07 | 0.02 |
| 500N | ||||||||||||||||
| 100 Cycles | 0.05 | FAIL | 0.39 | 0.83 | 2.37 | FAIL | 1.75 | 5.86 | 0.04 | 1 | 1.41 | FAIL | 1.21 | 2.45 | 0.43 | FAIL |
| 200 Cycles | 0.96 | 0.8 | 0.91 | 1.96 | 0.06 | 1.59 | 1.56 | 3.73 | 0.65 | |||||||
| 300 Cycles | 4.1 | 1.13 | 1.04 | 2.08 | 0.09 | 1.86 | 1.73 | 0.73 | ||||||||
| 400 Cycles | 1.48 | 1.23 | 0.1 | 2.01 | 1.78 | 0.7 | ||||||||||
| 500 Cycles | 1.73 | 1.41 | 0.11 | 1.85 | 25.19 | |||||||||||
| Failure Mode | Technical | Construct | Technical | Technical | Technical | Construct | Technical | Construct | Technical | Technical | Technical | Construct | Construct | Technical | Construct | Construct |
| Force | 500 | 500 | 578 | 675 | 500 | 500 | 500 | 500 | 816 | 500 | 724 | 460 | 500 | 500 | 500 | 293 |
4. Discussion
Our tested hypothesis was that the use of two continuous compression implants in a human cadaver model of transverse olecranon fractures would provide statistically equivalent biomechanical properties when compared to the gold standard, tension band wiring, during clinically relevant cyclic and load-to-failure testing. Utilizing isometric loading of the triceps tendon to simulate active elbow motion in a cadaveric model, we found no statistically significant differences in simulated-fracture stability or strength when comparing CCI and TBW fixation constructs. Importantly, both constructs limited gap formation to <1 mm through 500 cycles at 10N-loading and to <2 mm through 100 cycles at 500N-loading. In addition, cycles-to-failure and load-to-failure data suggested sufficient stability and strength for standard postoperative management protocols. Taken together, these results demonstrate that CCI can provide stabilization of 2U1B1d olecranon fractures that is similar to TBW in terms of biomechanics that allow for fracture healing with early range of motion.
Tension band wiring as well as many other fixation techniques and implants have undergone biomechanical testing using similar testing models to those utilized for the present study.6, 7, 8, 9,24, 25, 26, 27, 28 In addition, CCIs have been assessed biomechanically and clinically for indications for foot,13, 14, 15 spine,18 hand,17,19 and fracture18,20 surgery. Further, biomechanical stability of nitinol staple fixation has been demonstrated in a canine cadaver model of transverse olecranon osteotomies.23 Clinical study of CCIs in patients with olecranon fractures was recently performed with good outcomes demonstrating a proof of principle that CCIs provide satisfactory fixation for healing, though this research did not contain a control group for comparison.21 Our study is the first to the authors’ knowledge that demonstrates biomechanical equivalence of TBW and CCIs in 2U1B1d fractures in a human cadaveric model.
With the biomechanical requirements for fracture stabilization addressed, the other aspects related to methods of fixation for olecranon fractures can be considered. The subcutaneous nature of the proximal ulna provides little protection to prominent implants, such that orthopaedic hardware irritation, complications, and morbidity are common postoperative issues that require intervention. Implant removal is frequently necessary for painful orthopaedic hardware after fracture healing occurs, requiring additional surgery with associated increases in health care costs and risks including anesthesia, infection, and wound healing complications. CCIs provide low-profile fixation which could reduce postoperative implant irritation and the need for subsequent removal, especially in the elderly with poor skin quality and sick patients who may not tolerate a second procedure well. Additionally, fixation of a transverse olecranon fracture with TBW requires a large exposure for implant placement and familiarity with TBW technique in order to provide optimal stability. Fixation with CCIs, on the other hand, requires a smaller incision and application of the implant uses standardized instrumentation and technique such that consistent placement is readily achieved. These characteristics may also contribute to decreased operative time, exposing the patient to less risk for anesthesia-related complications and surgical site infections. A potential disadvantage for CCIs is related to cost. CCIs are more costly than the Kirschner wires and 18-gauge wire for TBW, generally more than $100 of facility cost, and more comparable in price to a locking olecranon plate at our institution. While these costs should be considered when selecting an implant for olecranon fracture repair, the potential advantages related to operative time, potential morbidity and complications that influence overall cost-effectiveness should also be taken into account.
The primary limitations to the present study center on the cadaveric biomechanical model with simulated fractures. In this model, soft tissues were removed, only active extension based on triceps loading with the humerus and ulna at 90° was simulated, and testing occurred at room temperature. As such, the results do not account for fracture-related damage, contributions to stability, or muscle forces associated with the peri-articular soft tissues. In addition, while the specimens were kept at 37 °C before and after implantation, biomechanical testing was performed at ambient temperature (∼21 °C), which could alter the biomechanical attributes of the CCIs as they are designed to exhibit optimal material properties at body temperature. As such, it is likely that the results reported for CCIs in the present study are conservative. However, biomechanical testing was performed using a standardized protocol with a matched-pair design to simulate active postoperative range of motion and repetitive pushing up from a chair such that comparisons are fair and clinically relevant. In addition, post-hoc power for the primary outcome measure was 0.81 such that hypothesis testing and statistical conclusions were valid.
5. Conclusion
Clinically relevant cadaveric biomechanical testing comparing TBW to CCI fixation for 2U1B1d olecranon fractures produced no significant differences in gap formation or load to failure. CCI fixation requires a smaller incision, is easy to perform, and involves a low-profile implant that may reduce morbidity. While cost is a concern when compared to tension band fixation, it is mitigated by the reduced surgical time, and decreased potential for secondary surgery and soft tissue complications. Based on biomechanical properties that match the gold standard, continuous compression nitinol implants are an appropriate option for fixation of transverse olecranon fractures with potential advantages over tension band wiring.
Funding/sponsorship
This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. Implants for the study were donated by DePuy Synthes.
Institutional ethical committee approval
This study was approved by the University of Missouri's Institutional Review Board.
Author contribution
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Schweser-- Conceptualization; Funding acquisition; Investigation; Methodology; Project administration; Supervision; Visualization; Writing – review & editing
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Moon-- Funding acquisition; Investigation; Methodology; Project administration; Roles/Writing – original draft
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Cook-- Data curation; Formal analysis; Methodology; Resources; Validation; Writing – review & editing
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Bezold-- Investigation; Methodology; Resources; Software; Supervision; Writing -- review & editing
Declaration of competing interest
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Dr. Schweser is a board or committee member for AAOS; is a paid consultant for KCI and ODI; is a board or committee member for the Orthopaedic Trauma Association; and is a paid presenter and receives research support from Synthes.
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Dr. Cook receives IP royalties, is a paid consultant, and receives research support from Arthrex, Inc; receives research support from Collagen Matrix Inc; receives research support from DePuy, A Johnson & Johnson Company; is on the editorial or governing board for the Journal of Knee Surgery; is a board or committee member for Midwest Transplant Network; is a board or committee member, receives IP royalties and research support from Musculoskeletal Transplant Foundation; receives research support from National Institutes of Health (NIAMS & NICHD); receives research support from Purina: Research support; receives research support from Regenosine; receives research support from SITES Medical; receives publishing royalties, financial or material support from Thieme: Publishing royalties, financial or material support; is a paid consultant for Trupanion; and receives research support from U.S. Department of Defense.
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Dr. Moon and Dr. Bezold have no conflicts of interest to disclose.
Acknowledgement
None.
References
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