Abstract
Background
Continuous compression implants (CCIs) can provide continuous compression across a fracture site. They are mainly used in foot/ankle surgery, with very limited descriptions in the literature of their potential for trauma. The aim of this study was to describe the use and associated outcomes of CCIs in modern day trauma practice.
Methods
This was a single-centred case series with a retrospective analysis of a prospectively maintained database of any patients who were treated with a CCI across 4 years. The primary outcome was to determine the mode of the CCIs and secondary outcomes were unplanned returns to theatre.
Results
60 patients were eligible with a mean age of 44.2 and 122 CCIs were used. 51 patients were treated for acute fractures, 9 were treated for non-unions, and 27 patients had open injuries. 42 of the 122 CCIs were used as definitive fixation (midfoot dislocations, an iliac wing fixation and isolated medial malleolus fixation), and the rest as adjuncts for fixation; of this remainder, 39 were used in reduction mode, 38 for fixation of key fragments, and 3 for compression. Ten patients returned to theatre, two for metalwork failure, two for infection and 6 for non-unions—three were acute fractures and three originally non-unions.
Conclusion
This paper demonstrates a novel technique for the use of CCIs in UK trauma practice as either definitive fixations or in three different modes as adjuncts to fixation. They do not replace tradition implants but do have equivalent rates of complications. They may be a useful tool in the arsenal for trauma surgeons.
Keywords: Shape memory alloys, Nitinol, Fractures, Trauma
Introduction
Bone staples have had a large range of application in orthopaedic surgery with their main uses being in elective foot, ankle, wrist, and hand surgery [1–3], with documented uses in less tradition areas, such as spine, elbow, and pelvis [4]. The development of shape-memory alloys (SMAs) has allowed staples to create continuous compression at their insertion site [1, 2, 5–7]. SMAs are able to change shape under certain environments, usually temperature related, and therefore, their behaviours can be predicted based on their biomechanical properties, which allows them to be inserted across fracture or non-union sites [5].
Nitinol is a shape-memory alloy made of equal parts of nickel and titanium, that displays unique properties as it exists in two crystallographic phases; an elastic state at lower temperatures, and a rigid shape when exposed to a higher temperatures [8]. Nitinol is unique as it contracts when heated (8), contrary to other metals. These properties can facilitate dynamic compression across an fracture site which could aid healing [8, 9]. Resultantly, bone staples made from SMAs such as nitinol are termed continuous compression implants (CCIs) due to this ability to provide compression.
Mechanically, a CCI can be thought of as a two-hole plate, with the bridge being the plate component and the legs of the staple acting as unicortical screws. They are often suited to small or irregular bones where more conventional implants would be difficult to use. They are also 16–32 times more elastic compared to other orthopaedic implants and so may tolerate more load before plastic deformation [5], albeit at a greater risk of failure. Biomechanical studies have shown unicortical CCIs within 2 mm of the opposite cortex can still provide good compressive force when compared to bicortical constructs [1, 6]. Shen et al. compared the CCIs to locking plates and found locking plates had better stability, but CCIs were able to recover their compression following repetitive stress than a plate [10].
Although they are extramedullary, their low profile and small footprint mean that there is little periosteal stripping needed which could make them suitable for operations where soft-tissue coverage is needed, such as open fractures [1, 3, 11–13]. They also hold the potential to capture small bony fragments that traditional implants may struggle to hold [4].
Sleiman et al.’s comprehensive review of the historical use of CCIs in orthopaedic surgery demonstrated their diverse potential, however, highlighted the need for further research to help define their indications and use [4]. CCIs could hold great potential as an aide in trauma surgery due to its unpredictable nature and the variety of different techniques needed to appropriately manage fractures.
This case series aimed to clarify the use of CCIs in modern day trauma practice including their indication, site, injury, and mode/action. Additionally, we looked to explore the rates of return to theatre, infection, and failure of metalwork in patients with injuries managed with CCIs and investigate separately if CCIs are quicker to insert than an equivalent low-profile plate with two unicortical screws.
Materials and Methods
Study Design
This is a single centre case series conducted in a major trauma centre in the United Kingdom. Data were prospectively collected in patients who underwent treatment of fractures with CCIs and then retrospectively reviewed and analysed.
Eligibility
We included any patient, of any age, undergoing fracture, or trauma care of any bone between September 2019 and May 2023; in which the operating orthopaedic consultant thought a CCI would be beneficial to their surgical management. This includes the management of acute fractures and non-unions; and open or closed injuries. Patients must have a minimum follow-up of 12 months at the same centre.
Primary Outcome
The primary objective for this case series was to understand the indication for CCIs in modern day trauma practice. This meant defining exactly what the CCI was indicated for and the injury and type of patient it was suited for, and would encompass acute fractures or non-union surgery.
Secondary Outcomes
Our secondary outcomes were to assess for complications amongst this series of patients. This included:
Unplanned return to orthopaedic theatre and the reasons for the return
Non-union rates of CCIs or constructs involving CCIs
Infection rates of CCIs or constructs involving CCIs
Metalwork failure rate of the CCIs.
Data Collection
The data that were prospectively collected included the type of surgery and injury and whether it was an open or closed injury. This also included the indication for surgery which was split into acute fracture or treatment of non-union. Outcome and complication data were retrospectively collected with a minimum of 12 month follow-up. The retrospective review was carried out by trauma fellowship trained orthopaedic consultants and included a subjective assessment of the indication for the CCI. Electronic patient records and notes, theatre attendances, post-operative X-rays, and clinic letters were reviewed to identify any further admissions for infection, returns to theatre, failure, and any other complications. All patients must have been followed up to a period of 12 months at the same centre to avoid missing complication data.
Types of CCIs
In the specific major trauma centre used for this case series, the operative surgeons have access to Depuy Synthes CCIs with three specific implants available—speed, speedtitan, and elite [14]. These vary based on size, with speed being the smallest (1.5 mm in width); speedtitan 3.5 mm in width; and the elite is the biggest (5.5 mm in width). Studies from Depuy Synthes has shown that the greater the size of the CCI, the greater its compressive ability amongst these three implants [14].
Results
Demographics
The prospective database contained data on 60 patients whose primary operation was between September 2019 and May 2023. Mean age was 44.2 and there was an even mix of male and female patients. In total, across these 60 patients, 122 CCIs were used. Demographics for the patient group can be found in Table 1.
Table 1.
Demographics of patients. Values are total numbers (%) unless stated otherwise
| Demographic | n (%) |
|---|---|
| Patients | 60 |
| Mean age (range) | 44.2 (8–89) |
| Males | 33 (55) |
| Females | 27 (45) |
| Mean ASA (range) | 1.95 (1–4) |
Primary Outcome: Operative Details
The majority of patients who were treated with CCIs were done so for acute fractures, with roughly an even split of open and closed injuries. Three of these patients had CCIs used for closed atypical bisphosphonate fractures of the femur. The most common site for the CCI was the tibia (25 patients) followed by the humerus (13 patients). All long bone procedures were treated with CCIs in conjunction with another method of fixation providing the stability. Twelve patients had CCIs used in isolation without other orthopaedic implants; ten of which were for midfoot dislocations, one patient had an isolated medial malleolus fracture (see Fig. 1), and another had an open iliac wing fracture (see Fig. 2). A unique case in this series includes a patient who had a distal pole avulsion fracture of the patella. A CCI was used to maintain reduction, and then, it was fixed with a tradition suture technique (see Fig. 3). See Table 2 for the operative details of the 60 cases.
Fig. 1.
Pre-operative radiograph (left), intraoperative image (middle) and post operative radiograph (right) in a full cast of an isolated medial malleolus fracture fixed with a single CCI
Fig. 2.
Pre-operative CT scan (left), intraoperative photo (middle) and post operative radiograph (right) of a left iliac wing open fracture fixed with 3 CCIs as definitive fixation
Fig. 3.
Pre-operative radiograph (left) and intraoperative image (right) of the patella fixation with a CCI used as a reduction adjunct to hold the distal fragment in place prior to more tradition fixation with suture through the patella
Table 2.
Operative details and indications of the 60 patients in the case series. Values are total numbers (%) unless stated otherwise
| Operative details | n (%) | ||
|---|---|---|---|
| Indication | Non-union | 9 (15) | |
| Acute fracture | 51 (85) | ||
| Atypical acute fracture | 3 (5) | ||
| Injury | Open | 27 (45) | |
| Closed | 33 (55) | ||
| Bone (AO classification) | Humerus (1) | 14 (23) | |
| Shaft (1.2) | 11 (18) | ||
| Distal (1.3) | 2 (3) | ||
| Forearm (2) | 3 (5) | ||
| Ulna | 2 (3) | ||
| Radius | 1 (2) | ||
| Femur (3) | 8 (13) | ||
| Proximal (3.1) | 3 (5) | ||
| Shaft (3.2) | 4 (7) | ||
| Distal (3.3) | 1 (2) | ||
| Patella (3.4) | 1 (2) | ||
| Tibia (4) | 25 (42) | ||
| Tibia proximal (4.1) | 4 (7) | ||
| Tibia shaft (4.2) | 13 (22) | ||
| Tibia distal (4.3) | 7 (12) | ||
| Medial malleolus (4.4) | 1 (2) | ||
| Pelvis (6) | Iliac wing | 1 (2) | |
| Foot (8) | Midfoot dislocations | 10 (17) | |
| Operative procedure | Plate fixation | 24 (40) | |
| Frame/external fixator | 4 (7) | ||
| Nail | 13 (22) | ||
| Nail and plate construct | 6 (10) | ||
| Suture fixation | 1 (2) | ||
| CCI only | 12 (20) | ||
Primary Outcome: The Indications of the CCIs
Across the 60 patients, 122 CCIs were used; 81 of which were a speed CCI; 40 were speedtitan and only one elite CCI was used in a closed atypical bisphosphonate fracture. 95% (117 of the 122) of CCIs were retained during their initial operation. Of the five removed, all were removed as they hindered or interfered with the definitive fixation and all five were used to reduce the fracture.
As determined by the fellowship trained trauma consultants, the indications for CCIs were defined as an adjunct to fixation or standalone definitive fixation. Of the adjuncts to fixation, the indication was further subdivided into the following categories:
Reduction tool for the fracture
Fixation of key fracture fragments
Compression across a fracture site.
Figures 4, 5, 6, 7 demonstrate examples of CCIs used in different modes based on the location and fracture pattern.
Fig. 4.
Pre-operative (left) and post-operative (right and bottom) plain radiographs of an example of CCIs used as definitive sole fixation of a midfoot dislocation
Fig. 5.
Plain radiographs of CCIs used to reduce a humeral fracture prior to definitive fixation with a plate
Fig. 6.
Pre-operative in cast (left) and post operative (right) plain radiographs of a patient who sustained an open intra-articular comminuted distal tibial fracture. This was definitely fixed with a tibial nail and a plate for the fibular. The joint was first reconstructed using screws and CCIs to fix key fragments which were small and would sit under the site of the open wound, which was covered by Plastic surgeons.
Fig. 7.
Pre-operative radiograph (right) and a series of intra-operative radiographs showing a CCI used to provide compression across an atypical bisphosphonate subtrochanteric femoral fracture as an adjunct to the definitive fixation
Of the 12 patients who had CCIs as standalone definitive fixation, ten were for midfoot injuries; one was for an isolated medial malleolus fracture and one for an open iliac wing fracture. In total, 42 (34%) CCIs were used in these 12 patients. Therefore, of the 122 CCIs used, 80 were used as adjuncts to fixation, of which 39 (32%) were used as a reduction tool; 38 (31%) to fix key fracture fragments that could not be held with other implants and three (2%) for compression across the fracture site. See Table 3 for further details of the use of CCIs and Fig. 8 for indications of CCIs based on the number of patients.
Table 3.
Indications for CCIs and whether they were retained or removed. Values are total numbers (%) unless stated otherwise
| CCI details | n (%) | |
|---|---|---|
| Number of CCIs used | 122 | |
| Indication of CCI | Definitive fixation | 42 (34) |
| Adjunct – Reduction | 39 (32) | |
| Adjunct – Fixation of key fragments | 38 (31) | |
| Adjunct – Compression | 3 (2) | |
| Type of CCI used | Speed | 81 (66) |
| SpeedTitan | 40 (33) | |
| Elite | 1 (0.8) | |
Fig. 8.
Indications of CCIs as determined by trauma fellowship trained consultants, n = no of patients from this series
Primary Outcome: Non-union Patients
In total in this series, there were nine patients with clinically and radiographically diagnosed non-unions that were subsequently treated operatively for their non-union with a CCI as an adjunct, see Table 4. Three were male, all of which originally had open injuries; the six female patients all had closed injuries. Four patients had humeral non-unions and were treated with another ORIF with CCIs as adjuncts; four were treated for distal tibial non-unions with CCIs and a frame. In these eight cases, the CCIs were used as reduction tools, except one distal tibial non-union, where it was used to fix key fragments. The only other patient had an atypical bisphosphonate femoral fracture non-union which was treated with a nail and plate construct and a CCI to aid compression across the non-union site.
Table 4.
Details of the patients who had previous non-unions and were then treated for their non-union with a CCI as an adjunct. Values are total numbers (%) unless stated otherwise
| Non-union details | n (%) | ||
|---|---|---|---|
| Gender | Male | 3 (33) | |
| Female | 6 (67) | ||
| Injury | Open | 3 (33) | |
| Closed | 6 (67) | ||
| Bone (AO classification) | Humerus (1) | 4 (44) | |
| Shaft (1.2) | 3 (33) | ||
| Distal (1.3) | 1 (11) | ||
| Femur (3) | Proximal (atypical subtrochanteric – 3.1) | 1 (11) | |
| Tibia (4) | 4 (44) | ||
| Shaft (4.2) | 1 (11) | ||
| Distal (4.3) | 3 (33) | ||
| Operative procedure | Plate fixation | 4 (44) | |
| Frame/external fixator | 4 (44) | ||
| Nail and plate construct | 1 (11) | ||
Secondary Outcomes: Return to Theatre
Ten patients had unplanned returns to orthopaedic theatres. Several other patients had planned returned to orthopaedic theatres for removal of frames/external fixators or definitive fixation of other fractures and several with open injuries returned to theatre under the care of the Plastic surgery team for soft-tissue procedures.
Secondary Outcomes: Metalwork Failure
Two of the 60 (3.3%) patients from our series had symptomatic failure of the CCI or metalwork. One of these patients had their CCI cut out from their patella suture fixation, but this was sustained after further trauma (a fall). The other patient had a midfoot dislocation fixed with five CCIs during their initial surgery. Two of the five CCIs had broken and the patient had removal of all metalwork due to pain.
Secondary Outcomes: Infection
Two patients (3.3%) developed infections and required a return to theatre for removal of metalwork, washouts, and revisions of fixations. One patient had an infection after their fixation (including a CCI as an adjunct) was used to treat a closed periprosthetic femoral fracture around a total knee arthroplasty. The second patient originally had an open distal tibial fracture, which went on to non-union. The non-union was treated with an adjunct CCI; however, this revision developed an infection and was subsequently revised again.
Secondary Outcomes: Non-union
Six patients (10%) who returned to theatre did so for non-unions. Three of these were non-unions initially. Of the 51 patients treated for acute fractures, only three (5.9%) went on to non-union. Two of these acute fracture patients were treated for open distal tibial injuries and the other one had a closed distal humeral fracture.
Further details of each patient who developed complications requiring a return to theatre can be found in Table 5.
Table 5.
Details of the ten patients who returned to theatre after their fixation with CCIs. This includes their original injury and the indication for the CCI of the initial surgery followed by the reason and details of their return to theatre
| Gender | Injury | Acute fracture or non-union | Initial fixation (with CCI) | Number of CCIs used | CCI indication | Reason for return to theatre | Second procedure | Time between procedures |
|---|---|---|---|---|---|---|---|---|
| Male | Open distal tibia | Non-union | Frame | 3 | Reduction | Infection | Revision nail | 8 months |
| Male | Open distal tibia | Non-union | Frame | 3 | Reduction | Non-union | Revision nail + plate fixation | 4 months |
| Male | Closed patella fracture | Acute fracture | Suture fixation | 1 | Reduction | Metalwork failure | Suture fixation | 5 weeks |
| Male | Open distal tibia | Acute fracture | Plate fixation | 1 | Reduction | Non-union | Frame | 8 months |
| Male | Closed distal femur (periprosthetic) | Acute fracture | Plate fixation | 1 | Reduction | Infection | Above knee amputation | 4 months |
| Male | Open midshaft tibia | Non-union | Frame | 3 | Fixation of key fragments | Non-union | Nail | 8 months |
| Female | Closed distal humerus | Acute fracture | Plate fixation | 1 | Reduction | Non-union | Revision plate fixation | 5 months |
| Female | Closed atypical fracture subtrochanteric femur | Non-union | Nail and plate fixation + valgus osteotomy | 2 | Reduction and compression | Non-union | Revision nail and plate fixation | 5 months |
| Female | Closed midfoot injury | Acute fracture | CCI only | 5 | Definitive fixation | Metalwork failure | Removal of metalwork | 12 months |
| Male | Open distal tibia | Acute fracture | Nail | 2 | Reduction, fixation of key fragments | Non-union | Revision nail | 4 months |
Discussion
Main Findings
This case series set out to identify the indications for continuous compression implants as part of a modern day UK trauma practice, and as such defined them as either definitive fixation methods or adjuncts for fixation. Their use as the sole implant (definitive fixation) is limited to midfoot dislocations for unusual fracture patterns. As adjuncts to fixation, the mode of the CCI (similar to the different modes of plates) can be thought of as reduction, fixation of key fragments, or compression mode. There is significant heterogeneity within the type of injury and injury patterns they have been used for and therefore offers verification of their versality. CCIs were only removed during the initial surgery if they interfered with the original fixation but still provided some reduction benefit during fixation.
Of the secondary outcomes, CCIs have demonstrated a 3.3% infection rate requiring revision, 3.3% metalwork failure rate requiring metalwork removal, a 5.9% non-union rate for treatment of acute fractures, and a 33% non-union rate for non-unions.
Wider Literature
Sleiman et al.’s review of CCIs highlighted their versality and diversity across varying aspects of orthopaedics but highlighted a significant gap in the literature regarding their use in fracture fixation [4]. Whilst they were popular for foot and ankle surgery, CCIs bare evidence for use in spine, upper limb, hand, and pelvic surgery. Whilst there review had very interesting findings, many of the papers involved had low number of patients or were on saw bone models/cadavers [4]. This highlights the lack of current evidence available for CCIs, and therefore, it is hard to relate the findings of this case series to others given the lack of literature.
When compared to wider orthopaedics, non-union rates for acute fractures are reported as between 5 and 10% [15, 16]; however, a consensus view by the European Federation of National Associations of Orthopaedics and Traumatology (EFFORT) published findings that showed it can be as low as 1.9% in adults [17]. Fracture related infection for closed simple fractures can be as low as 1% [18], but in contrast, the rates of infection from open lower limb injuries can be as high as 34.5%, as reported in the United States [19]. Rates of metalwork failure are problematic to define; however, for single plate fixation, this can be up to 18% [20]. With respect to these figures, CCIs or constructs with CCIs had very comparable numbers to tradition orthopaedic implants for infection, failure, and non-union.
Implications for Practice
Nitinol two crystallographic phases give it unique properties. Its conversion between these two phases is initiated by a higher (activation) temperatures [4, 8]. CCIs use body temperature as this activation temperature hence why this behaviour differently to traditional orthopaedic implants. McKnight et al. [1] showed that a nitinol staple placed 2 mm short of the far cortex had the same biomechanical compression as bicortical contructs. Now given Sleiman et al. [4]’s review also demonstrated the may be easier to insert and apply, there benefits for trauma widen given the intricacies of complex fracture patterns.
On top of this, Sleiman et al. [4] recommended CCI use for their low profile. Given complications, such as infection, wound breakdown, and soft-tissue irritation, are associated with higher profile implants [21–23], CCIs become more appealing for trauma associated with soft-tissue damage, including open fractures. This case series highlighted 24 patients treated with a CCI for an acute open injury and three (originally open) non-unions. Of these 27 patients, five patients had a return to theatre (three of which were the non-union patients). All of these were for non-unions except for one which was for infection. The low infection and wound breakdown rate may be attributed to the CCIs low profile.
It is clear, however, from the evidence presented in this case series, that CCIs do not replace plates, screws, nails, frames, or external fixation and cannot be the definitive fixation for a large proportion of fractures [24]. However, they can be used as adjunct for reduction, fixation, and compression, and should therefore form part of the tool kit for fracture management in modern trauma practice. The principal alternative to CCIs is a small plate with two cortical screws, which has a lower associated expense.
Limitations and Future Directions
This study has significant limitations, largely owing to the small sample size. Whilst the data set was prospectively collected, the review of this was retrospective in nature. This is also a single-centred study which had the availability of CCIs on the shelf, and so, this could also pose a restriction to other centres adopting CCIs within their implant portfolio for fracture management. To our knowledge, there are no large high-level evidence trials into the use of CCIs. There was also no established practice or guideline for CCI use, so their use was specifically up to the jurisdiction of the operating consultant.
Conclusion
This review has demonstrated the potential use of CCIs to treat a wide variety of acute fractures and non-unions for both open and closed injuries as either definitive fixations or adjuncts to fixation as part of a growing UK trauma practice; albeit at an extra economic burden. Whilst CCIs are not going to replace the conventional orthopaedic implants, this demonstrates their potential as a treatment adjunct for fracture fixation.
Acknowledgements
Nil.
Author Contributions
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Dylan Mistry, Usama Rahman, Chetan Khatri, William Carlos, and Alastair Stephens. The first draft was written by Dylan Mistry and Usama Rahman and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Conceptualisation Jayne Ward, Bryan Riemer; Methodology: all authors; Formal analysis and investigation Dylan Mistry, Usama Rahman, William Carlos, Alastair Stephens; writing—original draft Dylan Mistry, Usama Rahman; writing—review and editing: all authors; funding acquisition: none; resources: all authors; supervision: Jayne Ward and Bryan Riemer.
Data availability
Data for this case report can be access by emailing the corresponding author.
Declarations
Conflict of interest
The authors have no conflicts to declare.
Ethical approval
The article does not contain any studies performed on human participants or animals performed by any of the authors for the purpose of this study.
Informed consent
For this type of study formal consent is not required.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
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Data Availability Statement
Data for this case report can be access by emailing the corresponding author.