Perspectives of patients about bioabsorbable internal fixation for maxillofacial fractures.

PURPOSE: Resorbable/bioabsorbable internal fixation provides effective treatment for maxillofacial fractures and avoids the need for metal hardware removal. We evaluated the initial knowledge, attitudes, subjective demand, and treatment satisfaction of patients concerning bioabsorbable osteofixation for maxillofacial trauma.
MATERIALS AND METHODS: From May 2007 to October 2009, there were 71 patients (63 males and 8 females; mean age: 35 ± 15 years) included in this prospective study. The patients completed preoperative and postoperative (4-6 weeks and 1 year) questionnaires.
RESULTS: After receiving information, 70 patients (99%) preferred resorbable/bioabsorbable bone fixation, usually because they preferred to avoid a second operation to remove metal hardware (67 patients [94%]). The higher cost of resorbable/bioabsorbable bone fixation was believed and justified by 41 patients (58%) and not justified by 30 patients (42%). No adverse events were reported by 27 of 34 patients (79%) at 4-6 weeks and by 14 of 21 patients (67%) at 1 year after surgery. Most patients were very satisfied with the outcome of surgery.
CONCLUSION: Patients who have maxillofacial trauma have a high frequency of preference and high satisfaction with resorbable/bioabsorbable than metal osteofixation. Literature review showed increased activity in research and publication worldwide about resorbable bone fixation, suggesting that there may be increased patient demand for resorbable bone fixation in the future.

INTRODUCTION

Maxillofacial fractures are common injuries. Compared with the sequelae of trauma to the trunk and extremities, the face has a special importance for personal identity, self-perception, and communication. Therefore, patients perceive maxillofacial trauma and treatment with high attention and psychological distress.[12]

In the treatment of maxillofacial fractures, earlier resorbable, today bioabsorbable osteoconductive bone fixation systems are an alternative to metal internal fixation. Resorbable internal fixation avoids the disadvantages of metal internal fixation devices such as palpability, visibility, stress shielding, dysesthesia, temperature sensitivity, and interactions with diagnostic or therapeutic radiation. However, limited information is available about the patient's perspective about resorbable osteofixation systems for maxillofacial trauma and reconstructive surgery.[34] Literature search showed no studies evaluating the patient's perspective about resorbable fixation for the treatment of maxillofacial trauma. Furthermore, maxillofacial trauma patients may have social backgrounds that differ from with orthognathic surgery [Figures 1-3] because many trauma patients are injured because of assault, addictive behavior, sport, traffic accidents, and falls.[5]

Figure 1

Genioplasty

Figure 3

Le Fort I osteotomy

Mandible osteotomy

The development of bioabsorbable osteofixation devices has focused on resorption after successful bone fixation and fracture union. In addition, resorption of internal fixation devices may occur with incremental load to the healing callus without foreign body reaction.[678] Bioabsorbable fixation devices have been made from composite materials that include noncalcined, unsintered hydroxyapatite (HA) particles that contain carbonate ions uniformly distributed in a poly-L-lactide (PLLA) matrix. The PLLA matrix may contain 20–50% (±10%) HA by weight, and the composite is reinforced by forging (compression molding). Raw blocks are machined to make internal fixation devices that have high mechanical strength, absorbability, bone bonding capacity, and osteoconductivity.[91011]

The purpose of this study was to evaluate the initial knowledge and attitudes about bioabsorbable osteofixation in patients who had suffered from facial trauma. The evaluation included a subjective assessment of patients about adverse events and whether they expected to have adverse events after bioabsorbable osteofixation for treatment of maxillofacial fractures. In addition, a literature search was performed to assess international research activity about bioabsorbable osteofixation as a possible indication of increasing demand from the patients and the professional's side.

MATERIALS AND METHODS

Subjects

Patients who underwent surgical treatment of facial (midfacial or mandible) fractures in our department between May 2007 and October 2009 were prospectively enrolled in this study. Patients who had acute facial fractures of moderate severity and who were good candidates for safe treatment with bioabsorbable osteofixation were included in the study (71 patients; 63 males and 8 females; mean age, 35 ± 15 years; range, 16–78 years). Other patients were excluded for (1) unwillingness to participate in the evaluation; (2) Intensive Care Unit stay; (3) inability to provide consent because of sedation, dementia, or mental handicap, and (4) potential problems with compliance because of drug or alcohol addiction. No patients were excluded because of general disease or age. All included patients signed a separate informed consent form about the use of osteoconductive bioabsorbable fixation devices and anonymity of evaluation, information, and participation documents. The study was performed in accordance with the Declaration of Helsinki and was approved by our faculty's ethical board (No. 226/06).

Evaluation

The patients were evaluated with a questionnaire (nine questions) to determine their perceptions and experience with resorbable/bioabsorbable internal fixation [Table 1 and Figure 1]. After they received the first two questions of the questionnaire, they were given general information about the operation (surgical approach, risks, and different types of fixation systems).

Table 1

Questionnaire to evaluate perceptions of patients about Resorbable/Bioabsorbable internal fixation for Maxillofacial fractures

Using titanium bone fixation devices, 18% patients have adverse events such as heat or cold irritability, inflammation, palpability, plate loosening or plate fracture, interference with diagnostic or therapeutic radiation, local growth hindrance, impossibility of later hardware removal, local and systemic accumulation of titanium debris in the body, and unknown long-term consequences. Frequency of hardware removal is 3–31% (in our patients, 23%).[1213141516] In patients who had resorbable bone fixation previously, 6% patients had adverse events, usually foreign body granuloma (subacute inflammation with occasional fistula and drainage) that required curettage.[67]

Besides the above-mentioned information regarding the disadvantages of the various materials used, the patients were also presented with the advantages of the various plating systems, for example, the positive handling attributes of the titanium plates.

By presenting both the advantages and disadvantages, the patients were put in a situation where they received a proper informed consent and were able to voice a truly own and informed decision.

After they reviewed this information, they were asked for their preferred plating system. In the patient's informed consent for surgery, the general operative procedure was discussed. The patients were scheduled for surgery with either osteoconductive bioabsorbable osteofixation (Osteotrans Mx, Takiron, Osaka, Japan) or titanium internal fixation devices (MODUS, Medartis, Basel, Switzerland) according to their informed decisions. The bioabsorbable implants were expected to be resorbed during 5–6 years after surgery.[1011] After the patients had decided on their bone fixation preference, they anonymously received questions 3–7 before surgery and questions 8 and 9 after surgery (at 4–6 weeks and 1 year after surgery) [Table 1].

The preoperative questionnaire was completed by 71 patients (100%), early postoperative questionnaire by 34 patients (48%), and 1-year follow-up questionnaire by 21 patients (30%).

Literature search

A literature search was performed on April 18, 2013 with Internet databases (PubMed and EMBASE) using search words “resorbable osteosynthesis.” The 211 articles found were analyzed about publication date, country and language of study, author number, and associated institutions The impact factor for each journal was found by searching for each title on Web of Science, Thompson-Reuters, New York, USA (subscription database subscribed to by our institution).

The H-index for each journal and for the countries so indicated was found by searching SCImago Journal and Country Rank (available on the Internet). The Impact Factor and H-index are for the journals and countries as stated in those databases at the date and time of search (April 18, 2013) and preparation of the bibliometric overview was April 19.[171819]

Data analysis

Data analysis was done with a spreadsheet program (Excel, Microsoft Corp., Redmond, WA, USA). Total number and percentages were calculated for each question.

RESULTS

Preoperative assessment

Before surgery, most patients had not previously heard about resorbable/bioabsorbable bone fixation, and most patients anticipated no adverse events or occurrence of inflammation or instability [Table 2]. After receiving information, most patients preferred resorbable/bioabsorbable bone fixation, usually because they preferred to avoid a second operation to remove metal hardware and most patients were bothered about later metal hardware removal with metal fixation devices [Table 2]. The higher cost of bioabsorbable fixation to health insurance companies for resorbable/bioabsorbable bone fixation was believed justified or not justified by many patients [Table 2]. All the patients chose resorbable/bioabsorbable internal fixation except 1 patient who chose titanium internal fixation. Results of surgery (intraoperative feasibility and handling, success of retention and bone healing, and long-term sequelae) were reported previously.[20]

Table 2

Responses to preoperative questions to evaluate perceptions of patients about Resorbable/Bioabsorbable internal fixation for Maxillofacial fractures*

Postoperative assessment

At both 4–6 weeks and 1 year after surgery, most patients had no adverse events and most patients were very satisfied or satisfied with the outcome of surgery [Table 3]. The most frequent adverse event was swelling [Table 3]. The 1 dissatisfied patient complained of the residual swelling which was moderate.

Table 3

Responses to postoperative questions to evaluate perceptions of patients about Resorbable/Bioabsorbable internal fixation for Maxillofacial fractures*

Literature review

Literature review identified 211 articles that were published in 88 different journals, most frequently during the previous 12 years and in the Journal of Craniofacial Surgery, Journal of Oral and Maxillofacial Surgery, or British Journal of Oral and Maxillofacial Surgery [Table 4]. There were 25 different countries of location of the institutional affiliation of the first authors, most frequently Germany, United States, and France [Table 4]. The articles were published in 9 languages, most frequently English [Table 4]. The main topics of the articles were mandible fractures, orthognathic surgery, degradation, zygomatic and midfacial fractures, cranioplasties, minor fractures of the limbs, and thoracic surgery.

Table 4

Characteristics of articles identified in a literature search about Resorbable internal fixation of bone*

DISCUSSION

The present study showed that most patients had no previous knowledge about resorbable/bioabsorbable internal fixation [Table 2], even though these devices have been used in our service since 1998. Nevertheless, most patients preferred bioabsorbable instead of metal fixation devices to avoid a second operation for metal hardware removal [Table 2]. A previous study about patients having orthognathic surgery noted that 66% patients had known about resorbable internal fixation, possibly because of repeated preoperative interviews in the outpatient clinic and information transmitted between patients. Trauma patients typically require urgent treatment because of the accident and have shorter preoperative time than orthognathic patients to obtain information about their surgery.

The high preference for resorbable internal fixation noted in the present study (99%) [Table 2] was similar to that reported previously in patients who had distal radius fractures (95%) or orthognathic surgery (98%).[34] This preference was similar for trauma and reconstructive patients, even though many patients who had craniofacial trauma had been injured in interpersonal violence and had a different social background than orthognathic patients (data not shown). The present study showed a large information gap between the subjective perspectives of patients (high demand for bioabsorbable/resorbable osteofixation) and the common treatment offered to patients (titanium internal fixation).

The most common negative factor noted about metallic implants was the second operation necessary for metal removal [Table 2], similar to previous findings with orthognathic surgery and surgery for treatment of distal radius fractures.[34] Many patients were previously unaware about the medical necessity of removal of metal fixation devices (3–31%; in our patients, 23%).[1213141516] Metal hardware removal may be indicated for the treatment of heat or cold irritability, dysesthesia, stress shielding noted on radiography, palpability, exposed hardware, mechanical irritation, and interference with diagnostic or therapeutic radiation. Many patients believed that adverse events with bioabsorbable fixation may include inflammation, instability, or absence of resorption but that plate removal may not be required for these events [Table 2].

The literature search showed extensive research activity worldwide about resorbable internal fixation, mostly for mandible fractures and orthognathic surgery. Resorbable internal fixation devices have been used frequently for zygomatic and midfacial fractures and cranioplasties.[162021] The present and two previous studies about the perspectives of patients suggest that the level of knowledge and preferences of patients should be considered in further developing the international experience with resorbable/bioabsorbable internal fixation devices.

In the present study, most patients had no adverse events [Table 3]. The adverse events noted by some patients (swelling, inflammation, and paresthesias) are not specific to resorbable/bioabsorbable plates and may occur with titanium internal fixation devices. In a previous study of orthognathic surgery patients, postoperative questionnaires showed that 73% patients had no adverse events, and adverse events included hypaesthesia (12%), mastication problems, swelling, fistulas, inflammation, and pain; however, 55% patients were very satisfied and 37% were satisfied postoperatively and on long-term follow-up 64% were very happy and 23% were happy, while 6% were not sure and 7% unhappy with the outcome of surgery.[4] The unhappy patients were not patients with complications, but patients postoperatively unhappy with their facial appearance. Therefore similar results were attained regarding postoperative satisfaction.

Many studies have shown that resorbable plates may provide sufficient stability for treatment of craniofacial fractures.[20212223] In the present study, fewer patients were concerned about fracture stability (20%) [Table 2] than patients in a previous study of distal radius fractures (29%),[3] possibly because patients may perceive less bone loading after craniofacial trauma than trauma to the limbs. Nevertheless, stability is a concern in some patients who doubt that resorbable plates may have adequate strength for craniofacial fracture fixation; in comparison, no orthognathic surgery patients were concerned about instability, possibly because patients were informed in advance about biodegradable fixation, which may have increased their confidence.[4]

Follow-up studies typically have fewer dropouts after orthognathic surgery than craniofacial trauma.[20] This was observed in the present study compared with our earlier evaluation in orthognathic patients who had bone fixation with poly-L/DL-lactide-trimethylene carbonate implants.[4] Craniofacial trauma patients who return for follow-up typically are patients who have questions or adverse events, and this may cause negative selection bias.[202124] Therefore, the present study from a single center with few patients at 1-year follow-up may be limited by negative selection bias.

Although most patients (58%) felt that the higher cost of treatment with more expensive resorbable/bioabsorbable fixation devices was justified, many patients (42%) would not be willing to pay the additional cost of biodegradable fixation that may not be covered by their health insurance [Table 2]. Therefore, there is a discrepancy between patient demand and willingness to pay, even though the patients were informed about the risks and costs of metal hardware removal that would be avoided with resorbable fixation. Follow-up study of this issue may be of interest because of possible future cost restrictions for health care that may include a lack of health insurance coverage for metal hardware removal. Although many countries are scientifically active [Table 4], publication activity may not necessarily be related to health insurance coverage for resorbable/bioabsorbable fixation devices.

CONCLUSION

In summary, the present study showed a high patient preference for resorbable than metal internal fixation for the treatment of maxillofacial fractures. Patient's education about resorbable/bioabsorbable implants may enable patients to make better informed decisions and avoid the risks and costs of metal hardware removal. The literature review suggested that fractures with mild or moderate displacement may be treated effectively with resorbable bone fixation. The high preference of patients for resorbable implants and the avoidance of a second operation for metal hardware removal are factors that may encourage insurance companies to pay for the higher cost of resorbable implants.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.