If you don't remember your password, you can reset it by entering your email address and clicking the Reset Password button. You will then receive an email that contains a secure link for resetting your password
If the address matches a valid account an email will be sent to __email__ with instructions for resetting your password
Department of Oral and Maxillofacial Surgery, Barts Health NHS Trust, Royal London Hospital, Whitechapel Road, Whitechapel, London, E1 1FR, United Kingdom
Department of Oral and Maxillofacial Surgery, Barts Health NHS Trust, Royal London Hospital, Whitechapel Road, Whitechapel, London, E1 1FR, United Kingdom
There is ongoing discussion about patient-specific implants (PSI) to reconstruct orbital defects. Although PSI offer excellent clinical outcome, they are expensive. Subsequently, their routine application is not indicated. The purpose of this study was to estimate the frequency of implant malposition and revision procedures after primary orbital repair with preformed plates and to identify cases where primary use of PSI would help to prevent revision surgery. All patients included in the study were operated on for orbital fractures at the Royal London Hospital between August 2017 and July 2018. Selection criteria included adult patients treated for orbital fractures with a titanium plate. Revision was planned in symptomatic patients presenting with clear implant malposition. Seventy-nine patients with 81 implants were included, 33 of whom had multiple orbital wall fractures (medial wall and floor or all four walls) and were summarised as group 2. Group 1 consisted of single orbital floor/medial wall fractures. The five patients for whom revision surgery was planned or undertaken because of radiological poorly positioned implants and substantial clinical symptoms all had multiple wall fractures. This finding was significant (p = 0.006). The major reason for revision was a defect that was too large for the prescribed plate. Patients with large orbital defects needing surgical treatment are at risk of implant malposition. The orbital reconstruction with preformed plate evidences good outcome in single wall fractures. However, the risk of malposition increases massively with fracture size. We therefore postulate that in large, two-wall fractures, primary treatment with a PSI has to be considered.
Reconstruction of large orbital defects are universally recognised and are a significant surgical challenge. There is an ongoing discussion about the use of customised orbital plates to reconstruct orbital defects. Several studies indicate a better outcome in orbital surgery with patient specific implants (PSI) compared with generic manually-fabricated or even preformed titanium mesh implants. In addition, several companies can currently plan and produce these implants without delaying planned surgical procedures.
Customized titanium mesh based on the 3d printed model vs. manual intraoperative bending of titanium mesh for reconstructing orbital bone fracture: a randomized clinical trial.
These patient-specific implants (PSI) are highly precise and offer excellent clinical outcomes, with significantly lower revision rates when compared to other orbital plates. The reported surgical revision rate using traditional orbital plates is described between 17%
However, PSI are expensive and preoperative planning is didactic and carries a time implication. Subsequently, their routine application is not indicated. Furthermore the acute treatment of combined comminuted zygomatic and orbital fractures is not possible primarily with a PSI, so the treatment has to be split into two procedures under general anaesthesia, which leads to delays in recovery, longer hospital stays, and higher comorbidity.
The purpose of this study was to estimate the frequency of implant malposition and revision procedures after primary orbital repair with preformed plates and to identify cases where the primary use of a customised plate would help to prevent revision surgery. Previously, Schlittler et al described a significantly higher risk for revision surgery in patients with extensive orbital fractures.
The working assumption for this study, therefore, was that the acute treatment of multiple orbital wall fractures with customised orbital plates must be discussed in every case.
Patients and methods
Patients
This retrospective cohort study was conducted in a Level I trauma centre at the Royal London Hospital in Whitechapel, London, UK. All patients included in this study underwent surgical procedures for fractures of the orbital floor or wall under a single surgeon at the Department of Oral and Maxillofacial Surgery at St Bartholomew’s Health NHS Trust between August 2017 and July 2018. All patients provided informed consent. Every patient was treated with a DePuy Synthes preformed titanium plate (MatrixORBITAL™, DePuy Synthes).
Selection criteria included adult patients (>16 years) who had been treated for an orbital fracture with a preformed titanium mesh implant. Indications for surgical repair were similar to those described elsewhere including the presence of an isolated or combined orbital fracture causing an actual or expected functional or aesthetic deficit, and all defects greater than 2 cm2 in size.
Twenty-nine patients were excluded due to treatment by other surgeons (n = 25), missing preoperative or postoperative CT scans (n = 3) or being younger than 16 years (n = 1).
Revision was planned or undertaken following multidisciplinary-team review with a dedicated orthoptist in symptomatic patients with clear implant malposition.
Clinical symptoms included ocular motility disturbance, diplopia, hypoglobus, or obvious enophthalmos.
This study followed the Declaration of Helsinki on medical protocol and ethics. The regional Ethics Review Board of Bern, Switzerland, also approved the study.
Surgical technique
All surgical procedures were undertaken under general anaesthesia. For orbital repair, a Synthes preformed titanium orbital plate (size small or large) was applied and fixed with 1 - 2 screws to the infraorbital rim. The orbital floor, or walls, or both were exposed through a strict preseptal transconjunctival approach with additional canthotomy/cantholysis as described by McCord.
The size of the plate, as well as intraoperative problems, was noted. To assess the orbital defects and the incidence of malposition, a qualitative analysis of pre- and postoperative computed tomographic (CT) scans of the orbits were made, and the incidence and reasons for secondary revision procedures were evaluated.
Outcome measures
Patients were examined clinically and radiologically in a dedicated multidisciplinary facial trauma clinic and diagnosed with respect to bony involvement and ocular motility as well as concomitant globe injury. Clinical impairment including diplopia, eye motility disturbance, enophthalmos, or hypoglobus was recorded routinely. A preoperative 1 mm CT was obtained to assess the size and the location of the defect as well as the extent of any muscle or soft tissue entrapment. The extent of the fracture was classified according to the scores introduced by Jaquiery (Table 1).
To evaluate the accuracy of reconstruction, postoperative CT or digital volume tomography scans were done routinely. Two maxillofacial surgical specialists evaluated the accuracy of the titanium mesh according to a qualitative assessment of the implant position described by Ellis and Tan (Table 1).
The plate position in the anterior, middle, and posterior locations of the defect was rated and classified as ‘ideal’, ‘adequate,’ or ‘poor’ and the highest value was used for rating. All revision procedures were planned with customised PSI. As per our working assumption, we subdivided fractures into two groups: single wall orbital fractures (Jaquiéry 1-3) in group 1 and multiple orbital wall fractures (Jaquiéry 4 and 5) in group 2 (Table 1).
Statistical analysis
Using IBM SPSS® software package (version 24, IBM Corp) and Excel for Mac version 12.3.4. the groups were compared using chi squared tests (nominal data), Mann-Whitney U tests (non-normally distributed interval data or ordinal data) or Student’s t test (normally distributed interval data (age)). Additionally the effect size (Cramer’s V) for significant results is provided.
Results
From August 2017 to July 2018 a total of 79 patients with pure orbital trauma and 81 implants were operated on at the Department of Oral and Maxillofacial Surgery using a Synthes preformed titanium orbital plate. Four patients were excluded due to lack of postoperative CT scans (n = 2), being younger than 16 years old (n = 1) and having primary treatment at an external unit (n = 1). All remaining 79 patients included in the study were operated on through a strict pre-septal transconjunctival approach plus/minus lateral canthotomy/cantholysis (Table 2). Sixty eight patients were male, and the right side was affected slightly more frequently (n = 41), The mean (SD) defect size of all fractures, referring to Jaquiéry,
Table 2Results of patients with single wall fracture compared with multiple wall fractures. Data are expressed as number, except where otherwise stated.
Thirty-three cases showed multiple wall fractures including the complete medial orbital wall and floor (Jaquiéry class 4) or involving all four walls (Jaquiéry class 5) and were summarised as group 2. Group 1 consisted of single orbital floor or medial wall fractures (Jaquiéry class 1-3).
There were no significant differences in age (single wall fracture: mean (SD) age 35 (13) years, median 33.4; multiple wall fracture: 32 (12) years, median 29; p = 0.366), sex (male single wall fracture (n = 40) male multiple wall fracture: (n = 28); p = 0.790) and time between diagnosis and surgery (single wall fracture: mean (SD) days 13 (11) days, median 10; multiple wall fracture: 13 (9) days), median 11; p = 0.680).
In group 2, the implant position was rated poor in 8 cases compared to only 4 in group 1. This difference is not significant (p = 0.077), however, there is a moderate statistical effect between the groups (χ2(2) = 5.132, p = 0.077, Cramer’s V = 0.257). The five patients in whom revision surgery was planned due to radiological poorly-positioned implants and substantial clinical symptoms all had multiple wall fractures. This finding is significant (χ2(1) = 7.553, p = 0.006, Cramer’s V = 0.305). There were four patients with combined double vision and enophthalmos and one patient with double vision only. Of the five patients who clearly needed revision to improve the clinical outcome, only three were finally operated on. One patient refused to have a further operation, the second patient failed to attend. The major reason for revision was that the defect was too large for the prescribed plate.
Discussion
This retrospective analysis was conducted on 79 patients who had been treated for 81 orbital fractures with a preformed titanium plate. The strength of the study is based not only on the large volume of orbits treated in a short period of time but also on the equality of treatment. All patients were operated on under the care of the single experienced surgeon using an identical surgical protocol directly or as first assistant. This allows for a strict analysis of the results without bias.
Although many studies show good outcomes with classical preformed and manually bent titanium implants in orbital reconstructive surgery, there is a progressive trend for PSI in maxillofacial surgery in general. As the orbital anatomy is complex and reconstruction of extensive fractures even in experienced hands challenging, many maxillofacial surgeons regard these implant as the gold standard treatment in future. Different studies show a better outcome and lower revision rate in orbital surgery with PSI compared with traditional preformed or manually bendable titanium plates.
Customized titanium mesh based on the 3d printed model vs. manual intraoperative bending of titanium mesh for reconstructing orbital bone fracture: a randomized clinical trial.
In addition, some medical companies can provide PSI within 3-5 working days and make acute treatment easily possible.
Customised orbital implants do not lead to delayed surgery provided that the patient pathways and the infrastructure of the clinic are well organised. It should be appreciated that the time to surgery and its outcome is still controversially discussed.
Some authors like Brucoli et al describe a significantly higher incidence of enophthalmos and diplopia if fractures are not treated within two weeks, whereas Dal Canto et al specify no difference.
Our study shows a very low overall revision rate (6.2%) although 29 operations were delayed and done after the discussed 14 days limit. We postulate that there must not be a strict timeline. Even though our clinical experience mirrors the study results from Yamanaka et al
that patients with orbital-floor trap-door blowout fractures with incarcerated tissue should be repaired as soon as possible, our results do not illustrate the fact that early post-injury operations have better outcomes than those repaired after eight days. We agree with other authors who describe no apparent difference in surgical outcome between early (within two weeks) and late surgical repair.
Our overall revision rate is far lower than the 17% previously described by Schlittler et al in a similar study group in Berne, Switzerland over a longer period of time.
While this study demonstrates better accuracy with larger defects and significantly increased numbers, it still illustrates the fact that all patients are at risk of implant malposition despite the seniority or experience of the surgeon.
there is good evidence for the acute use of orbital PSI due to reported lower revision rates. Nevertheless, the use of CAD/CAM technology and PSI does not necessarily produce better postoperative ophthalmological results compared with standard treatment.
In addition, the cost of these implants is also significantly higher than for standard implants. In times where pressures on national health services are increasing and medical costs steadily climb, the indication for an orbital PSI should be made carefully. As it is always difficult to estimate the cost-value ratio; discussions are thus of great importance. Hence, the purpose of this study was to point out indications where PSI should be used initially to avoid unsatisfactory outcomes. Because our results show a significant higher revision rate in multiple wall fractures, we recommend that a PSI should always be considered in Jaquiéry classes 4 and 5. In our study group, only large multiple wall fractures needed revision interventions whereas single wall fractures show a good outcome with the classical preformed implants. Beside the complex surgical dissection of multiple wall fractures, preformed plates are in extensive fractures insufficient to completely cover the defect. This aggravates perfect placement of the plate and leaves a patient with a residual orbital volume increase behind. Good radiological and clinical outcomes can therefore often be achieved only with PSI.
Finally, we also wish to point out the importance of a strict preseptal transconjunctival approach in orbital surgery. All the patients in our study were operated on by this specific technique including a lateral canthotomy/cantholysis. Using this approach, one can preserve the orbital septum and contents. In our opinion, this is one of the main reasons for good overall outcomes across both groups even if the plate position was only satisfactory (Fig. 1, Fig. 2, Fig. 3).
Patients with large orbital defects who require surgical treatment with titanium mesh implant are in general at risk of implant malposition. The reconstruction of orbital defects with preformed titanium plate gives a good outcome, especially in single wall fractures. However, the risk of malposition increases significantly with the fracture size and extension. If the fracture includes the complete orbital floor and medial wall, preformed plates are often insufficient to completely cover the defect. We therefore postulate that in large fractures involving multiple walls, primary treatment with a PSI should be considered. Only then, long-term sequelae due to inadequate reconstruction can be reduced.
Conflict of interest
We have no conflicts of interest.
Ethics approval
This study followed the Declaration of Helsinki on medical protocol and ethics. Furthermore, the regional Ethical Review Board of Bern, Switzerland, approved the study.
Patients’ permission/consent
We have obtained patients’ permission/consent. All data was recorded after anonymisation using the RedCap database. The included pictures of computed tomographic scans show no identifying information.
References
Gander T.
Essig H.
Metzler P.
et al.
Patient specific implants (PSI) in reconstruction of orbital floor and wall fractures.
Customized titanium mesh based on the 3d printed model vs. manual intraoperative bending of titanium mesh for reconstructing orbital bone fracture: a randomized clinical trial.
30317-X&id=gr1.jpg){kind=link}
30317-X&id=gr2.jpg){kind=link}
30317-X&id=gr3.jpg){kind=link}