Abstract
Aim and objectives
The aim of this study was to analyse the outcomes of orbital floor reconstruction with two types of orbital implants and assess patients’ quality of life.
Material and methods
39 sequential patients with clinical and radiological evidence of orbital floor fracture, presenting diplopia, enophthalmos, paraesthesia or a post traumatic residual orbital deformity were included in this study and randomised for orbital floor reconstruction using porous polyethylene sheet (Biopore™) or preshaped titanium mesh on a 3D model. Their pre and postoperative quality of life were compared. Success rate was assessed and scored with a minimum of zero (none) and a maximum of ten (excellent) for improvement in the signs of diplopia, enophthalmos, hypoglobus, paraesthesia and aesthetics.
Results
Both QOL scores and Success score was greater in cases which reconstruction of orbital floor was performed with preshaped titanium mesh as compared to those with Biopore™.
Conclusion
Preshaped titanium mesh shows better results than reconstruction with Biopore™. However a large sample size and a long term follow up is needed for generating the best evidence. Quality of life extensively improves after orbital floor reconstruction motivating the patients desire to live.
Keywords: Orbital floor injury, Orbital floor fracture, Orbital floor reconstruction, Quality of life
1. Introduction
With the exigency of high frequency of orbital fractures, the psychological trauma to the patients is also increased, due to impaired vision, poor aesthetics and deterioration in their quality of life. The aim of this study was to analyse the outcomes of orbital reconstruction for their success and assess patients’ quality of life.
2. Materials and method
39 sequential patients with clinical and radiological evidence of orbital floor fracture, presenting diplopia, enophthalmos, paraesthesia or a post traumatic residual deformity were included in this prospective study after obtaining their informed consent and Institutional ethical approval. Patients were randomly allocated to either of the two groups for reconstruction of orbital defect using a manually preshaped titanium mesh on a 3D model or intraoperatively contoured porous polyethylene (Biopore™) sheet.
An existing scar or subciliary incision was used to expose the orbital rim fracture. The fracture fragments if mobile and attached to periosteum, were reduced. The reconstruction material was placed on the defect following the orbital contour, such that it could rest on normal bone on all sides and posteriorly on the posterior ledge of bone; and was fixed with at least two titanium screws at the infraorbital rim.
Patients were clinically evaluated preoperative, immediate post operative, and then at 1, 3 and 6 months for quantitative assessment of diplopia, enophthalmos, hypoglobus, paraesthesia and esthetics by a single unblinded observer. Radiographic evaluation included non contrast CT face or cone beam CT. Quality of life was assessed using a questionnaire with 4 sections, of which the section 1 was on overall health, adapted from EROTC QLQ-C30 (version 3) and had 2 questions, the section 3 was adapted from Jung, 2016 (appearance, 9 questions), while the section 2 (social issues, 6 questions) and section 4 (orbit, 9 questions) were developed from a pilot study by us. The score ranged from 1 to 7 in section 1, and from 1 to 4 in the rest and NA option in all the questions. Question 1 with highest score showed better QOL while rest other questions with minimum score showed better QOL.
Success of the orbital floor reconstruction was also quantitatively assessed by a single observer not blinded to the study, who scored with a minimum of zero to a maximum of ten by assessment of diplopia, enophthalmos, hypoglobus, paraesthesia and esthetics and scoring each from 0 (no improvement) to 10 (excellent improvement).
3. Results
Average time of reporting of patients to our unit usually was 20 days after trauma as they visited our unit after their orthopaedic or neurosurgical intervention. Some patients even visited us 7–8 months later for correction of their post traumatic residual deformity. All patients were operated in our unit in the next 4–5 days.
The orbital floor defect size ranged from 1 to 3 cm, mean 1.81 ± 0.70 (1.0–3.2) measured in the sagittal sections. The antero-posterior length of defect was more than the medio-lateral width in the majority of cases (94%). No significant difference was found in various dimensions of defect size between the techniques (Fig. 1, Table 1). Orbital floor reconstruction was done by Biopore™ (41.02%), preshaped titanium mesh (58.97%) by randomly allocating the patients to either of the two groups.
Fig. 1.
Defect size and success with material.
Table 1.
Defect size and material used.
| Material | Defect Size |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Rim to ant edge |
Rim to post edge |
Length of # |
Width of # |
area |
||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
| Medpore (n = 16) | 0.42 | 0.34 | 2.00 | 0.62 | 1.59 | 0.58 | 1.33 | 0.69 | 2.37 | 1.85 |
| Titanium Mesh (n = 23) | 0.45 | 0.35 | 2.23 | 0.79 | 1.78 | 0.73 | 1.49 | 0.71 | 3.01 | 2.35 |
| Significance | t = 0.281, p = 0.780 | t = 0.931, p = 0.359 | t = 0.820, p = 0.419 | t = 0.667, p = 0.510 | t = 0.886, p = 0.382 | |||||
The success score of preshaped titanium mesh reconstruction (9.26) was greater than Biopore™ (8.25). Fig. 2, Table 2 Significant changes in success score were observed (p = 0.049). Correlation between Success score & QOL score, r = 0.321, p = 0.034. The positive significant correlation was found.
Fig. 2.
Association of Success and QOL score with Material.
Table 2.
Association of Success Score and QOL score with Material Used.
| Material Used | Success Score |
QOL Score Diff (Pre-Post) |
||
|---|---|---|---|---|
| Mean | SD | Mean | SD | |
| Medpore | 8.25 | 1.65 | 7.5 | 7.28 |
| Titanium Mesh | 9.26 | 1.29 | 11.57 | 12.54 |
| Significance | t = 2.046, p = 0.049 | t = 1.19, p = 0.242 | ||
The enophthalmos correction success score of 10 was achieved with preshaped titanium mesh and 8.75 for Biopore™ and was found to be significant (p = 0.028) Fig. 3, Table 3. The hypoglobus correction success score of 9 was achieved with use of preshaped titanium mesh and 7.50 for Biopore™ and it was also significant (p = 0.047). The diplopia correction success score of 9.78 was achieved with use of preshaped titanium mesh and 9.06 for Biopore™ and it was insignificant.
Fig. 3.
Success in correction of Enophthalmos, Hypoglobus and Diplopia according to material.
Table 3.
Success in correction of Enophthalmos, Hypoglobus and Diplopia according to material.
| Biomaterial | Success score |
|||||
|---|---|---|---|---|---|---|
| Enopthalmos |
Hypoglobous |
Diplopia SS |
||||
| Mean | SD | Mean | SD | Mean | SD | |
| Medpore | 8.75 | 2.24 | 7.50 | 2.58 | 9.06 | 2.02 |
| Titanium Mesh | 10.00 | 0.00 | 9.00 | 1.72 | 9.78 | 1.04 |
| Significance | t = 2.30, p = 0.028 | t = 2.07, p = 0.047 | t = 1.31, p = 0.200 | |||
The significant changes in QOL scores were found for all items except items Q4.40 (p = 0.315), and Q4.60 (p = 0.127). Changes in mean QOL from Pre to Post test (p < 0.001) were statistically significant (Fig. 4, Table 4).
Fig. 4.
QOL and Pre to Post Treatment Comparisons question wise, and mean scores.
Table 4.
QOL and Pre to Post Treatment Comparisons question wise, and mean scores.
| QOL Total Score | Mean | SD | t-value | p-value |
|---|---|---|---|---|
| Pre Test | 52.45 | 14.42 | 6.83 | <0.001 |
| Post Test | 41.77 | 10.95 |
4. Discussion
Orbital fractures cause severe injuries like loss of vision, disfigurement of face, lifelong morbidity, low motivation and low quality of life, alarming financial expenses, and mortality.1,2 In this prospective cohort study, we have assessed the incidence of orbital fractures, analysed the outcomes of orbital reconstruction and observed their quality of life.
Ideally, an orbital implant should have the thickness of orbital floor, similar visco-elastic properties, easy to manipulate, rigid to prevent deformation, not prone to infection or extrusion, easily fixed to the surrounding structures, available and cost effective.
Porous polyethylene sheet being porous allows in-growth of surrounding soft tissue and bone leading to decreased scarring, capsular formation, foreign body reaction and infection rates. Infection does not occur for 5 weeks that is till the vascularisation phase. It gets anchored into position within 2 weeks.3 Extra ocular muscle limitation by soft tissue adherence is prevented by the ingrowths, provides positional stabilization, prevents migration and extrusion.4, 5, 6 Sheet when inserted underneath the periosteum on the healthy margins of the fractures and also the periosteum of the orbital floor is scrupulously sutured at the infraorbital rim, fixation is not compulsory. The implant can be easily cut with scissors and contoured. However, it is not seen in the radiographs and has a density alike to the non-fat orbital tissue on a CT.2 A medpore sheet has a thickness of 1.5 mm as compared to titanium, which has a thickness of 0.85 mm.7 The extrusion rate is low.
Ellis and Tan8 found that titanium can be accurately shaped for reconstruction of the internal orbit and complex defects. It is readily available, easily sterilized, and biocompatible, integrates into adjacent bone,9, 10, 11 can be visualized in postoperative imaging, produces lesser artifacts,12 provides good support, does not change its place or shape with time, and needs lesser operative time and equipment. Sugar et al.13 documented that due to the meshed structure, connective tissue grows through and around it, preventing its movement. Even in thin sections it has good physical strength so the larger defects can be reconstructed without the sagging of the reconstruction material. Kessler and Hardt14 noticed re-pneumatization of the paranasal sinuses in contact with the mesh and observed no mesh related infections in the same regions. Kuttenberger15 stated that titanium mesh does not wrinkle or kink and thus allows complex reconstructions that provides staunch functional and long-term aesthetic results. It can be used as a substitute to bone or cartilage grafts. Gunarajah and Samman16 in their systematic review interpreted that titanium mesh is apt for defects of more than 2 cm.2 However, titanium use is associated with scarring around the extraocular muscles due to the perforations in the mesh.8 Also, the removal of the titanium mesh in secondary surgery is difficult. Thirdly, it lacks the viscoelastic properties of the orbital floor. Scolozzi and Jaques17 evaluated the accuracy and constancy of ‘‘freehand’’ manipulation of titanium mesh for orbital reconstruction in 7 patients using computer-aided volumetric measurement of the bony orbits and illustrated that the reconstructed orbit had an precision of 7% when compared to the contra-lateral uninjured site.
The enophthalmos correction success score of 10 was achieved with preshaped titanium mesh and 8.75 for Biopore™. The hypoglobus correction success score of 9 was achieved with use of preshaped titanium mesh and 7.50 for Biopore™. The diplopia correction success score of 9.78 was achieved with use of preshaped titanium mesh and 9.06 for Biopore™.
Overall success score of preshaped titanium mesh reconstruction (9.26) was greater than Biopore™ (8.25) as Biopore™ could not be accurately shaped according to internal orbit and could not provide volumetric correction for complex defects. Some of the cases were old trauma cases in which the zygomatic bone was malunited, hence hypoglobus persisted even after orbital floor reconstruction and patient did not opt for zygomatic osteotomy and reduction that involved a longer surgery, and a higher treatment cost.
The significant changes in QOL scores (Fig. 4) were found for all the questions except for Q4.40 (p = 0.315), lower eyelid turning or sagging outward and Q4.60 (p = 0.127) post operative watery eyes.
Ectropion was seen in 12 (30.76%) patients. They were treated conservatively with massage. It subsided within 6 months. Watery eyes were seen in 14 (35.89%) patients, which resolved with time. The cause of watery eyes was either infection or blocked tear duct. In cases with infection, systemic broad spectrum antibiotics were prescribed with antibiotic eye drops for a week. In cases of blocked tear ducts, a warm wet towel was advised to place on the eye which helped with the blockage. All patients showed improvement gradually.
The reported range of postoperative diplopia is 8–40% in the literature.18 Amongst 15 (38.46%) patients in our series with diplopia, 6 (15.38%) patients complained of diplopia post operatively which is within the reported range. Causes of persistent diplopia include trauma to the muscle, fibrosis and muscle paresis. Hosal and Beatty19 suggested diplopia is likely to be seen in older patients and during delayed repair, in cases of periorbital tissues entrapment and damage.
Amongst 34 (87.17%) patients with pre operative hypoglobus, 6 (15.38%) patients showed hypoglobus post operatively. Amongst 32 (82.05%) patients with preoperative enophthalmos, 4 (10.25%) cases showed persistent enophthalmos. The reported incidence of enophthalmos postoperatively ranges from 7 to 27% in the literature.20 Fat atrophy can be the cause of enophthalmos, but it may also be due to inadequate reconstruction of the orbital cone.
Out of 33 (84.61%) patients complaining for paraesthesia, 7 (17.94%) patients complained even post operatively, however that improved in a year with a drug combination of methylcobalamin and pregablin. Methylcobalamin is a form of Vitamin B12 and pregablin belongs to the group of anticonvulsant. Post operative infection was seen in 3 (7.69%) patients that were controlled by use of systemic antibiotics within a week. Chronic pain was seen in 9 (23.07%) patients that gradually subsided within 1 month on analgesics. There was no post operative vision loss.
There are different patterns of orbital fracture that presents the possibility of severity bias. Therefore, high variance in the size and severity of defect can be a confounding factor. Also, there exists a possibility of surgeon’s bias as 3 surgeons, although of the same professional level and similar surgical skills, operated in our study. The success of each surgical procedure was scored by a single observer, not blinded to the study, so some observer based bias also may have existed in our study. The groups of respective reconstruction materials that were used did not have equal number of patients. Biopore™ was used in 16 (41.02%) patients, preshaped titanium mesh in 23 (58.92%) cases.
5. Conclusion
Quality of life extensively improves after orbital floor reconstruction motivating the patients desire to live. Success rate of a manually preshaped titanium mesh is higher than that with Biopore™. The preshaped Titanium mesh on a 3D model allows precise reconstruction of the internal orbital defects with lesser complications and better post operative results. However a large sample size and a long term follow up is needed for generating the best evidence.
Acknowledgement
DHR MRU KGMU for extending their support, and Dr Meghashish Sharma for helping in the designing of the QOL questionnaire.
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.jobcr.2021.01.012.
Contributor Information
Sneha Gupta, Email: gahens@gmail.com.
Divya Mehrotra, Email: divyamehrotra@kgmcindia.edu.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
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