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Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study
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JORMAS-711; No. of Pages 7 J Stomatol Oral Maxillofac Surg xxx (2019) xxx–xxx
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Original article
Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study D. Bhargava a,*, R.S. Neelakandan b, Y. Sharma c, V. Dalsingh d, S. Beena a, P. Gurjar a a
Department of Oral and Maxillofacial Surgery, People’s College of Dental Sciences and Research Center, People’s University, 462037 Bhanpur, Bhopal, Madhya Pradesh, India MAHER, Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu, India c Department of Oral and Maxillofacial Surgery, People’s Dental Academy, People’s University, 462037 Bhanpur, Bhopal, Madhya Pradesh, India d Department of Oral and Maxillofacial Surgery, Lenora Institute of Dental Sciences, Rajahmundry, Andhra Pradesh, India b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 9 April 2019 Accepted 18 June 2019
Purpose: The aim of this study was to investigate the feasibility of a custom made alloplastic Temporomandibular Joint (TMJ) device design in patients undergoing temporomandibular (TM) Total Joint Reconstruction (TJR). Objective: TMJ disease with functional and anatomic distortion dictates the need for TJR. There are various materials to reconstruct a TMJ. However, various factors, such as cost, availability of prosthetic joint, limit its use to tertiary health care center. Hence, we have investigated the feasibility and efficacy of the custom made alloplastic TMJ prosthesis (DARSN TM Joint Prosthesis) with the advantage of being acceptable financially and the overall Quality of life (QoL) diagnosed with TMJ ankylosis and End Stage Joint Disease (ESJD) selected from the study population. Materials and methods: The study group comprised of 20 patients with TMJ ankylosis or End Stage Joint Disease (ESJD) who needed TM TJR of which few subjects in the study population had history of failed previous surgery to the TMJ region. The patients underwent resection of the joint followed by TJR using the custom made alloplastic TMJ prosthesis. Various subjective and objective variables were evaluated such as the Jaw Function (JF), Inter-incisal opening (IO), Diet intake (DI), Quality of Life (QoL) using a Psychometric Modified Likert Scale and nutritional status of the patient using the Mid-Upper Arm Circumference (MUAC) as reference. Results: All the subjective and objective variables showed significant improvement in the postoperative period as compared to the preoperative period. The JF score increased with a mean score of 6.25 (P < 0.00001). Postoperative mean DI score was 3.15 (P < 0.00001) and IO increased up to 29–38 mm in 95% of the study population. The study population exhibited an improved overall QoL and nutritional status post-operatively. Follow up period of 1 year showed significant functional improvement among the study population. Conclusion: The results shows that the custom made alloplastic joint replacement is safe and effective and reliable alternative to treat patients with TMJ disease which restricts the normal function to a greater degree requiring TM TJR.
C 2019 Elsevier Masson SAS. All rights reserved.
Keywords: Temporomandibular joint disorder Ankylosis Arthroplasty Prosthesis and Implants Quality of life Joint replacement
1. Introduction Alloplastic total temporomandibular joint (TMJ) reconstruction restores function and form of the TMJ and it is indicated in patients diagnosed with wide range of joint pathologies such as
* Corresponding author. Private Practise, H-3/2, BDA Colony, Nayapura, Lal Ghati, Airport Road, Bhopal, 462001, Madhya Pradesh, India E-mail address: [email protected] (D. Bhargava).
ankylosis, neoplasia that may require extensive resection of the TMJ, failed autogenous graft, and mutilative joint disease among the few. Temporomandibular disorders related pain has a significant psychosocial impact on patients with strong female predilection. [1] With the increasing evidence of success of alloplastic prosthesis in orthopedic literature and the growing need to provide a definitive treatment for TMJ disorders, the various artificial TMJs are being investigated and some of them are in use.
https://doi.org/10.1016/j.jormas.2019.06.005 C 2019 Elsevier Masson SAS. All rights reserved. 2468-7855/
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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The possible challenges faced to replace a natural TMJ with total alloplastic temporomandibular prosthesis includes financial factors, achieve harmony in function between the alloplastic joint, osseous structure and the muscles controlling the movement, masticatory function, speech among the few factors. To our best knowledge, no study has been carried out among the Indian population to investigate the effect of a custom made alloplastic TMJ prosthesis which is not only cost effective but also reliable option to restore the jaw function after temporomandibular (TM) total joint reconstruction (TJR). The aim of this study is to evaluate the efficacy of the custom made alloplastic TMJ prosthesis (DARSN TM Joint Prosthesis) (Fig. 1) [2,3] with the advantage of being acceptable financially and the overall Quality of life (QoL) diagnosed with TMJ ankylosis and End Stage Joint Disease (ESJD) selected from the study population. 2. Materials and methods A prospective clinical study was undertaken to assess the predictability and feasibility of the total alloplastic TMJ reconstruction using custom prosthesis at Jaw Joint Consultancy Service, South East Asia. The study was performed in compliance with the Declaration of Helsinki on medical protocol and approved by the institutional ethical committee, IRB number: PCDS/ACAD/8/2014/ **. The custom made TMJ alloplastic device was approved by Food and Drug administration authority of India (Maharashtra, MH State) and Medical Device–Quality Management System ISO 13485:2016. Inclusion criteria for the present study were 1) Patients above 18 years of age willing to sign the written informed for the procedure, 2) No contra-indication to General Anesthesia, 3) ASA-I (No systemic disease), 4) Patients with TMJ ankylosis or ESJD requiring surgical intervention for the condition. Under aseptic precautions, Alkayat - Bramley incision with an anterior temporal extension superiorly to the top of the helix was
Fig. 1. Custom made alloplastic Temporomandibular Joint prosthesis (DARSN TM Joint Prosthesis).
outlined followed by blunt dissection ensuring preservation of vital anatomic structures in the vicinity of surgical site. The superficial temporal vessels and auriculotemporal nerve was retracted anterior to the flap exposing the lateral aspect of the joint. The opening was extended anteriorly and posteriorly by dissecting along the lateral aspect of fossa and eminence or the ankylotic mass. Then the periosteum was stripped covering the lateral aspect of articular eminence along the root of zygomatic arch. A medial dissection along the zygomatic arch was done. In cases with ankylosis (Fig. 2), the ankylotic mass was identified and the superior and inferior arthroplasty cuts were marked and executed, protecting the medial soft tissues. Ultra high molecular weight polyethylene (UHMWPE) fossa was fixed through this approach in a pre-determined manner (Figs. 3 and 4). Inter-maxillary fixation was done with eyelet wiring. The lateral and caudal surface of the zygomatic arch was shaped using a rose head shaped TC bur to house the UHMPE fossa secured to the zygomatic arch. The ramal component of the joint was secured using Grade V Ti screws to the lateral ramus after reshaping the anti-lingula (where required) using standard Hinds incision. The joint movements were checked intra-operatively before the closure. A partial thickness tongue shaped temporalis muscle flap was harvested. A tin foil template was used and marking was transferred to the muscle for partial thickness flap harvesting to ascertain the size of muscle flap required to provide coverage over the alloplastic joint [4]. The rotated muscle flap was sutured to the surrounding tissue around the alloplastic joint using absorbable polygalactin sutures to provide additional coverage to the implanted alloplastic material that would aid in prevention of joint exposure to the external environment and also peri-prosthetic joint infections before the pre-auricular skin closure (Fig. 5). Meticulous closure of the wound was undertaken from deep to most superficial layer, closing all fascial planes.
Fig. 2. Reconstructed three dimensional (3D) lateral view of the Temporomandibular Joint (TMJ) ankylotic mass requiring gap arthroplasty and total alloplastic reconstruction of the joint.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Fig. 5. Partial thickness rotation advancement temporalis flap secured using 3-0 absorbable polygalactin suture for alloplastic joint coverage. Fig. 3. Intra-operative view of Ultra high molecular weight polyethylene (UHMPE) fossa component.
Patients were assessed for various subjective and objective parameters such as jaw function (JF), diet intake (DI), overall quality of life (QoL), inter-incisal opening (IO) using a Psychometric Modified Likert scale [5] to access the various parameters and
Fig. 4. Intra-operative view of the lateral ramal plate made of Grade 5 Titanium (Ti) alloy.
mid-upper arm circumference (MUAC) as reference to assess nutritional status [6] along with radiographic evaluation (Figs. 6 and 7) preoperatively and postoperatively up to 1 year follow up period by a single operator.
Fig. 6. Postoperative Postero-anterior (PA) view of skull for a patient rehabilitated with alloplastic DARSN TM Joint Prosthesis in right side in an unilateral ankylosis case.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Table 1 Likert scale was used to assess the Subjective and Objective parameters and the values were evaluated among the study population preoperatively and postoperatively. S. No
Variable
Jaw Function Pre-op
Post-op
Pre-op
Post-op
Pre-op
Post-op
1 2
Mean Standard Deviation (SD) T Value P Value
9.65 0.4894
6.25 1.209
8.5 1.701
3.15 1.755
3.1 8.54
33.01 2.318
3 4
11.6619 < 0.00001
Diet
Inter-incisal opening (mm)
9.78706 < 0.00001
10.97776 < 0.00001
SD: Standard deviation (P < 0.05).
Fig. 7. Postoperative Postero-anterior (PA) view of skull rehabilitated with alloplastic DARSN TM Joint Prosthesis bilaterally.
3. Statistical Analysis Statistical analysis was performed by using SPSS 20.2 for windows (SPSS, Chicago, IL). Independent samples were used for comparison. The data were expressed as mean SD unless otherwise indicated.
4. Results A total of 20 patients (N = 20) requiring unilateral alloplastic TMJ TJR were included in this study with mean age of 28.75 years. The total number of females and males among the study population was 8 (40%) and 12 (60%) respectively. Patients diagnosed with unilateral ankylosis and ESJD were 18 (90%) and 2 (10%) respectively. The number of previous history of TMJ surgeries among the 20 patients were recorded. Among the patients diagnosed with ankylosis, N = 4 (20%) patients had previous history of more than 2 surgeries, N = 2 (10%) had 2 surgeries, N = 4 (20%) had underwent a single surgery. A total of N = 8 (40%) patients underwent primary release of the ankylosed TMJ with alloplastic joint replacement. In ESJD group, one N = 1 (5%) underwent > 2 surgeries previously and N = 1 (5%) underwent primary release of the TMJ. The JF was assessed preoperatively and postoperatively. The average mean JF in the pre-operative and post-operative period is 9.65 and 6.25. The t value was found to be 11.6619 with a significant p value of < 0.00001. All the patients, N = 19 (95%) except one N = 1 (5%) were found to exhibit better jaw movements on the contralateral side post-operatively. One patient, N = 1 (5%) with ESJD was found to have restricted JF (Table 1, Graph 1). All the patients exhibited an improvement in the DI during the postoperative period as compared to preoperatively. The mean DI preoperative score was 8.5 as opposed to 3.15 in the postoperative period with a significant p value of < 0.00001 signifying the
improved dietary intake of the patients from the study population (Table 1, Graph 1). IO is a significant indicator for mouth opening in the postoperative phase. N = 13 (65%) of the patients had no mouth opening before surgery. Two patients, N = 2 (10%) with ESJD had restricted mouth opening to some extent. Postoperatively, N = 19 (95%) had showed improved mouth opening ranging from 29– 38 mm. Adequate mouth opening aided in enhanced food intake after the surgery signified by the improved diet score. One patient, N = 1 (5%) continued to have decreased mouth opening with pus discharge from the surgical site on the postoperative 8th day (Table 1, Graph 1). QoL was assessed for all the patients who underwent surgery. All the patients, N = 20 (100%) had rated that the QoL was Worse in the pre-operative period contrary to the postoperative period where, N = 19 (95%) of the patients accepted that their QoL has improved after the surgery. One patient, N = 1 (5%) patient who had pus discharge postoperatively experienced same QoL as the preoperative period. An additional parameter of nutritional status of the patient was assessed in the preoperative period, 6th postoperative and 12th postoperative month using MUAC as the reference. The mean MUAC are 20.33, 23.86 and 25.83 with a SD of 1.104, 2.241 and 2.745 in the preoperative, 6th and 12th postoperative month. An inter-group comparison of preoperative and 6th postoperative month MUAC value and preoperative and 12th postoperative month MUAC was done to determine the T and P values. The T value for preoperative and 6th postoperative month MUAC value is 6.32799 with a significant P value of < 0.00001. The intergroup comparison of preoperative and 12th postoperative month MUAC had a t value of 8.31309 with a statistically significant P value of < 0.00001. This effectively assessed the nutritional status of the patient who had decreased dietary intake owing to TMJ problem causing reduced mouth opening (Table 2, Graph 2). One patient, N = 1 (5%) with ESJD exhibited pus discharge associated with pain in the preauricular region on the 8th postoperative day leading to failure of the alloplastic joint. The patient underwent more than 2 surgeries previously before receiving an alloplastic joint. This was the only complication observed among the study population. The results from the present study indicates that alloplastic joint replacement is safe and effective method to treat patients with TMJ disease which restricts the normal function to a greater degree. 5. Discussion Alloplastic TM TJR aims at restoring function and form of the TMJ and it is indicated in patients diagnosed with wide range of joint pathologies such as ankylosis/re-ankylosis, neoplasia that may require extensive resection of the TMJ, failed autogenous graft, mutilative joint disease among the few.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Graph 1. Assessment of Jaw function (JF), Diet intake consistency (DI) using a Likert Scale and Inter-incisal opening (IO) [In Millimeters, mm] in the preoperative and postoperative phase.
Table 2 Mid-Upper Arm Circumference (MUAC) as reference to assess the nutritional status of the study population in the preoperative and postoperative period [Assessed in Centimeters]. S. No
Variable
MUAC (Pre-op)
MUAC (Post-op, 6th month)
MUAC (Post-op, 12th month)
1 2
Mean Standard Deviation (SD)
20.33 1.104
23.86 2.241
25.83 2.745
3 4
T Value P Value
Comparison of preoperative and 6th post-op month MUAC
Comparison of preoperative and 12th post-op month MUAC
6.32799 < 0.00001
8.31309 < 0.00001
SD: Standard deviation (P < 0.05).
Graph 2. Mid-Upper Arm Circumference as reference to assess the nutritional status among the study population in the preoperative and postoperative phase (In Centimeters, cm).
As observed by Mercuri LG et al. to assess the safety and effectiveness of patient fitted total TMJ reconstruction system patients who underwent implantation of alloplastic TMJ (Techmedia/TMJ concepts) device with a follow-up of 14 years, there was a significant improvement in various parameters such as pain,
mandibular function, diet consistency and QoL postoperatively concluding that patient fitted total TMJ reconstruction system continues to be safe, effective and reliable modality providing long term results [7]. The results obtained in the present study was corelating with the above mentioned study as there was not only
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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improvement in all the subjective and objective parameters assessed but also the custom made alloplastic TMJ prosthesis was cost-effective for the patients who underwent surgery. This was similar to the results observed by Wolford LM et al. [8]. Any surgical procedures can lead to complications at various ˜ o F et al. in their descriptive peri-operative phase. Bricen observational study among patients who received TMJ replacement using custom made alloplastic prosthesis observed various complications such as transitory paresis of facial nerve and myofascial pain syndrome [9] contrary to the complications observed by Jones RH who encountered sensory disturbance to the lip and joint dislocation as complications among his study population [10]. We observed a complication of pre-auricular swelling and pus discharge from the surgical site leading to removal of the device which could be owing to secondary infection in the surgical site and not due to the failure of the alloplastic device as supported by the evidence from the literature where the authors observed among their study population requiring removal of the alloplastic joint was commonly due to infection or heterotopic bone formation and not owing to the device [11,12]. Elledge R et al. conducted a cross-sectional analysis of all the TMJ replacement that was registered in the British Association of TMJ Surgeons (BATS). They observed that there was significant improvements in the mean inter-incisal opening, pain, jaw function, dietary intake, and overall quality of life in the postoperative period as compared to the preoperative period [13]. This was similar to the results observed by Gerbino G et al. [14] from their study where they concluded that single stage resection of the ankylotic mass and total TMJ reconstruction using an alloplastic joint is a safe, effective and reliable modality for establishing long term function. Various studies in the literature have assessed mandibular function, food intake, pain and and overall QoL in patients who undergo TM TJR. But no evidence in literature have assessed nutritional status of patients with restricted mouth opening due to TMJ disease. We have used MUAC as reference to assess nutritional status preoperatively and 6th and 12th using circumference of the right upper arm measuring from the mid-point between tip of the acromium and olecranon process [6]. This parameter can be used to effectively assess the nutrition in patients who had decreased food intake in case of ankylosis and other jaw related disorders. Westermark A observed that some patients gained significant weight post-operatively after TMJ replacement though they did not include it as a parameter in his study [15]. In this study, a partial thickness temporalis flap was preferred over the full thickness muscle flap to cover the alloplastic joint so as to avoid the excessive pre-auricular bulge, which may be unesthetic in the postoperative period. Literature has emphasized the importance of rotational muscle flaps in prosthetic knee joints, which can have implications with regard to the TMJ replacement surgery. In many cases, muscle flaps were used postoperatively to cover the wound dehiscence of prosthetic knee. The results obtained were convincing with decreased failure rates of the joints as it prevents direct communication of the alloplastic joint with the external environment, increases blood supply to the region therefore increases local oxygen concentration, immune-mediator transport, nutrients and metabolic exchanges and antibiotic concentration in the region. It reduces dead space and also creates a conducive biologic environment for the joint [16,17]. Alloplastic DARSN TM Joint Prosthesis by Bhargava D et al. is an all Titanium (Ti) prosthesis constructed considering the biomechanical principles consists of Ti alloy (Grade 5) condylar head and neck with a lateral ramal attachment plate and UHMWPE joint fossa. The neck of the prosthesis is a connector between the condylar head and the lateral ramal attachment plate. The neck is designed to incorporate a slight distal off-set, which places the
condylar head distal to the long axis of the ramal fixation plate. This particular biomechanical design utilizes the advantage of ‘‘Swan neck design’’ which evades the problem of implant-bone interface obstruction faced with right angled designs. UHMWPE fossa acts as an intervening material between the metallic condylar head and the temporal bone to prevent any mechanical damage to the bone during function. All the components are fixed using Grade 5 Ti screws. Screws are round headed with a single slot meant to seat on the counter sink design of the fixation hole after reaching the desired depth in the bone for anchorage [2]. Various evidence in the literature highlights the use of alloplastic TMJ prosthesis for TJR and if the surgery is performed preceding a proper diagnosis and planning yields satisfying results for both the patient as well as the operating surgeon which is agreed from the present study as alloplastic prosthesis does not require a second surgical site as in case of autogenous replacement of the joint [18] and also in support with the fact that it is cost-effective and reliable after follow up period for long term results [19–23]. 6. Conclusion The contemporary designed custom made TMJ prosthesis is biocompatible, cost-effective for TM TJR and found to improve mandibular form and function thereby reducing disability and prevent the need for a donor site surgery in case of an autogenous material thereby reducing the donor site morbidity, hospital stay and patient discomfort. A proper diagnostic work-up and meticulous surgical planning is required before considering the patient for surgery along with the skill of the operator and aseptic precautions during surgery are the factors which yields successful results. From this study, we can conclude that the Total titanium condylar prosthesis with UHMWPE joint fossa design serves as a reliable and safe TM TJR device with significant post-operative results. Funding Self-funded. Disclosure of interest The authors declare that they have no competing interest. Ethical approval Obtained. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from the patients involved in this study. Declaration DARSN TM Joint Prosthesis is developed as a ‘‘Make in India’’ initiative, undertaken as Post-Doctoral research at People’s University, Bhopal and Meenakshi Academy of Higher Education and Research (MAHER), Chennai, INDIA. Design Patent ref 2541/MUM/2015.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
JORMAS-711; No. of Pages 7 J Stomatol Oral Maxillofac Surg xxx (2019) xxx–xxx
Available online at
ScienceDirect www.sciencedirect.com
Original article
Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study D. Bhargava a,*, R.S. Neelakandan b, Y. Sharma c, V. Dalsingh d, S. Beena a, P. Gurjar a a
Department of Oral and Maxillofacial Surgery, People’s College of Dental Sciences and Research Center, People’s University, 462037 Bhanpur, Bhopal, Madhya Pradesh, India MAHER, Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital, Chennai, Tamil Nadu, India c Department of Oral and Maxillofacial Surgery, People’s Dental Academy, People’s University, 462037 Bhanpur, Bhopal, Madhya Pradesh, India d Department of Oral and Maxillofacial Surgery, Lenora Institute of Dental Sciences, Rajahmundry, Andhra Pradesh, India b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 9 April 2019 Accepted 18 June 2019
Purpose: The aim of this study was to investigate the feasibility of a custom made alloplastic Temporomandibular Joint (TMJ) device design in patients undergoing temporomandibular (TM) Total Joint Reconstruction (TJR). Objective: TMJ disease with functional and anatomic distortion dictates the need for TJR. There are various materials to reconstruct a TMJ. However, various factors, such as cost, availability of prosthetic joint, limit its use to tertiary health care center. Hence, we have investigated the feasibility and efficacy of the custom made alloplastic TMJ prosthesis (DARSN TM Joint Prosthesis) with the advantage of being acceptable financially and the overall Quality of life (QoL) diagnosed with TMJ ankylosis and End Stage Joint Disease (ESJD) selected from the study population. Materials and methods: The study group comprised of 20 patients with TMJ ankylosis or End Stage Joint Disease (ESJD) who needed TM TJR of which few subjects in the study population had history of failed previous surgery to the TMJ region. The patients underwent resection of the joint followed by TJR using the custom made alloplastic TMJ prosthesis. Various subjective and objective variables were evaluated such as the Jaw Function (JF), Inter-incisal opening (IO), Diet intake (DI), Quality of Life (QoL) using a Psychometric Modified Likert Scale and nutritional status of the patient using the Mid-Upper Arm Circumference (MUAC) as reference. Results: All the subjective and objective variables showed significant improvement in the postoperative period as compared to the preoperative period. The JF score increased with a mean score of 6.25 (P < 0.00001). Postoperative mean DI score was 3.15 (P < 0.00001) and IO increased up to 29–38 mm in 95% of the study population. The study population exhibited an improved overall QoL and nutritional status post-operatively. Follow up period of 1 year showed significant functional improvement among the study population. Conclusion: The results shows that the custom made alloplastic joint replacement is safe and effective and reliable alternative to treat patients with TMJ disease which restricts the normal function to a greater degree requiring TM TJR.
C 2019 Elsevier Masson SAS. All rights reserved.
Keywords: Temporomandibular joint disorder Ankylosis Arthroplasty Prosthesis and Implants Quality of life Joint replacement
1. Introduction Alloplastic total temporomandibular joint (TMJ) reconstruction restores function and form of the TMJ and it is indicated in patients diagnosed with wide range of joint pathologies such as
* Corresponding author. Private Practise, H-3/2, BDA Colony, Nayapura, Lal Ghati, Airport Road, Bhopal, 462001, Madhya Pradesh, India E-mail address: [email protected] (D. Bhargava).
ankylosis, neoplasia that may require extensive resection of the TMJ, failed autogenous graft, and mutilative joint disease among the few. Temporomandibular disorders related pain has a significant psychosocial impact on patients with strong female predilection. [1] With the increasing evidence of success of alloplastic prosthesis in orthopedic literature and the growing need to provide a definitive treatment for TMJ disorders, the various artificial TMJs are being investigated and some of them are in use.
https://doi.org/10.1016/j.jormas.2019.06.005 C 2019 Elsevier Masson SAS. All rights reserved. 2468-7855/
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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The possible challenges faced to replace a natural TMJ with total alloplastic temporomandibular prosthesis includes financial factors, achieve harmony in function between the alloplastic joint, osseous structure and the muscles controlling the movement, masticatory function, speech among the few factors. To our best knowledge, no study has been carried out among the Indian population to investigate the effect of a custom made alloplastic TMJ prosthesis which is not only cost effective but also reliable option to restore the jaw function after temporomandibular (TM) total joint reconstruction (TJR). The aim of this study is to evaluate the efficacy of the custom made alloplastic TMJ prosthesis (DARSN TM Joint Prosthesis) (Fig. 1) [2,3] with the advantage of being acceptable financially and the overall Quality of life (QoL) diagnosed with TMJ ankylosis and End Stage Joint Disease (ESJD) selected from the study population. 2. Materials and methods A prospective clinical study was undertaken to assess the predictability and feasibility of the total alloplastic TMJ reconstruction using custom prosthesis at Jaw Joint Consultancy Service, South East Asia. The study was performed in compliance with the Declaration of Helsinki on medical protocol and approved by the institutional ethical committee, IRB number: PCDS/ACAD/8/2014/ **. The custom made TMJ alloplastic device was approved by Food and Drug administration authority of India (Maharashtra, MH State) and Medical Device–Quality Management System ISO 13485:2016. Inclusion criteria for the present study were 1) Patients above 18 years of age willing to sign the written informed for the procedure, 2) No contra-indication to General Anesthesia, 3) ASA-I (No systemic disease), 4) Patients with TMJ ankylosis or ESJD requiring surgical intervention for the condition. Under aseptic precautions, Alkayat - Bramley incision with an anterior temporal extension superiorly to the top of the helix was
Fig. 1. Custom made alloplastic Temporomandibular Joint prosthesis (DARSN TM Joint Prosthesis).
outlined followed by blunt dissection ensuring preservation of vital anatomic structures in the vicinity of surgical site. The superficial temporal vessels and auriculotemporal nerve was retracted anterior to the flap exposing the lateral aspect of the joint. The opening was extended anteriorly and posteriorly by dissecting along the lateral aspect of fossa and eminence or the ankylotic mass. Then the periosteum was stripped covering the lateral aspect of articular eminence along the root of zygomatic arch. A medial dissection along the zygomatic arch was done. In cases with ankylosis (Fig. 2), the ankylotic mass was identified and the superior and inferior arthroplasty cuts were marked and executed, protecting the medial soft tissues. Ultra high molecular weight polyethylene (UHMWPE) fossa was fixed through this approach in a pre-determined manner (Figs. 3 and 4). Inter-maxillary fixation was done with eyelet wiring. The lateral and caudal surface of the zygomatic arch was shaped using a rose head shaped TC bur to house the UHMPE fossa secured to the zygomatic arch. The ramal component of the joint was secured using Grade V Ti screws to the lateral ramus after reshaping the anti-lingula (where required) using standard Hinds incision. The joint movements were checked intra-operatively before the closure. A partial thickness tongue shaped temporalis muscle flap was harvested. A tin foil template was used and marking was transferred to the muscle for partial thickness flap harvesting to ascertain the size of muscle flap required to provide coverage over the alloplastic joint [4]. The rotated muscle flap was sutured to the surrounding tissue around the alloplastic joint using absorbable polygalactin sutures to provide additional coverage to the implanted alloplastic material that would aid in prevention of joint exposure to the external environment and also peri-prosthetic joint infections before the pre-auricular skin closure (Fig. 5). Meticulous closure of the wound was undertaken from deep to most superficial layer, closing all fascial planes.
Fig. 2. Reconstructed three dimensional (3D) lateral view of the Temporomandibular Joint (TMJ) ankylotic mass requiring gap arthroplasty and total alloplastic reconstruction of the joint.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Fig. 5. Partial thickness rotation advancement temporalis flap secured using 3-0 absorbable polygalactin suture for alloplastic joint coverage. Fig. 3. Intra-operative view of Ultra high molecular weight polyethylene (UHMPE) fossa component.
Patients were assessed for various subjective and objective parameters such as jaw function (JF), diet intake (DI), overall quality of life (QoL), inter-incisal opening (IO) using a Psychometric Modified Likert scale [5] to access the various parameters and
Fig. 4. Intra-operative view of the lateral ramal plate made of Grade 5 Titanium (Ti) alloy.
mid-upper arm circumference (MUAC) as reference to assess nutritional status [6] along with radiographic evaluation (Figs. 6 and 7) preoperatively and postoperatively up to 1 year follow up period by a single operator.
Fig. 6. Postoperative Postero-anterior (PA) view of skull for a patient rehabilitated with alloplastic DARSN TM Joint Prosthesis in right side in an unilateral ankylosis case.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Table 1 Likert scale was used to assess the Subjective and Objective parameters and the values were evaluated among the study population preoperatively and postoperatively. S. No
Variable
Jaw Function Pre-op
Post-op
Pre-op
Post-op
Pre-op
Post-op
1 2
Mean Standard Deviation (SD) T Value P Value
9.65 0.4894
6.25 1.209
8.5 1.701
3.15 1.755
3.1 8.54
33.01 2.318
3 4
11.6619 < 0.00001
Diet
Inter-incisal opening (mm)
9.78706 < 0.00001
10.97776 < 0.00001
SD: Standard deviation (P < 0.05).
Fig. 7. Postoperative Postero-anterior (PA) view of skull rehabilitated with alloplastic DARSN TM Joint Prosthesis bilaterally.
3. Statistical Analysis Statistical analysis was performed by using SPSS 20.2 for windows (SPSS, Chicago, IL). Independent samples were used for comparison. The data were expressed as mean SD unless otherwise indicated.
4. Results A total of 20 patients (N = 20) requiring unilateral alloplastic TMJ TJR were included in this study with mean age of 28.75 years. The total number of females and males among the study population was 8 (40%) and 12 (60%) respectively. Patients diagnosed with unilateral ankylosis and ESJD were 18 (90%) and 2 (10%) respectively. The number of previous history of TMJ surgeries among the 20 patients were recorded. Among the patients diagnosed with ankylosis, N = 4 (20%) patients had previous history of more than 2 surgeries, N = 2 (10%) had 2 surgeries, N = 4 (20%) had underwent a single surgery. A total of N = 8 (40%) patients underwent primary release of the ankylosed TMJ with alloplastic joint replacement. In ESJD group, one N = 1 (5%) underwent > 2 surgeries previously and N = 1 (5%) underwent primary release of the TMJ. The JF was assessed preoperatively and postoperatively. The average mean JF in the pre-operative and post-operative period is 9.65 and 6.25. The t value was found to be 11.6619 with a significant p value of < 0.00001. All the patients, N = 19 (95%) except one N = 1 (5%) were found to exhibit better jaw movements on the contralateral side post-operatively. One patient, N = 1 (5%) with ESJD was found to have restricted JF (Table 1, Graph 1). All the patients exhibited an improvement in the DI during the postoperative period as compared to preoperatively. The mean DI preoperative score was 8.5 as opposed to 3.15 in the postoperative period with a significant p value of < 0.00001 signifying the
improved dietary intake of the patients from the study population (Table 1, Graph 1). IO is a significant indicator for mouth opening in the postoperative phase. N = 13 (65%) of the patients had no mouth opening before surgery. Two patients, N = 2 (10%) with ESJD had restricted mouth opening to some extent. Postoperatively, N = 19 (95%) had showed improved mouth opening ranging from 29– 38 mm. Adequate mouth opening aided in enhanced food intake after the surgery signified by the improved diet score. One patient, N = 1 (5%) continued to have decreased mouth opening with pus discharge from the surgical site on the postoperative 8th day (Table 1, Graph 1). QoL was assessed for all the patients who underwent surgery. All the patients, N = 20 (100%) had rated that the QoL was Worse in the pre-operative period contrary to the postoperative period where, N = 19 (95%) of the patients accepted that their QoL has improved after the surgery. One patient, N = 1 (5%) patient who had pus discharge postoperatively experienced same QoL as the preoperative period. An additional parameter of nutritional status of the patient was assessed in the preoperative period, 6th postoperative and 12th postoperative month using MUAC as the reference. The mean MUAC are 20.33, 23.86 and 25.83 with a SD of 1.104, 2.241 and 2.745 in the preoperative, 6th and 12th postoperative month. An inter-group comparison of preoperative and 6th postoperative month MUAC value and preoperative and 12th postoperative month MUAC was done to determine the T and P values. The T value for preoperative and 6th postoperative month MUAC value is 6.32799 with a significant P value of < 0.00001. The intergroup comparison of preoperative and 12th postoperative month MUAC had a t value of 8.31309 with a statistically significant P value of < 0.00001. This effectively assessed the nutritional status of the patient who had decreased dietary intake owing to TMJ problem causing reduced mouth opening (Table 2, Graph 2). One patient, N = 1 (5%) with ESJD exhibited pus discharge associated with pain in the preauricular region on the 8th postoperative day leading to failure of the alloplastic joint. The patient underwent more than 2 surgeries previously before receiving an alloplastic joint. This was the only complication observed among the study population. The results from the present study indicates that alloplastic joint replacement is safe and effective method to treat patients with TMJ disease which restricts the normal function to a greater degree. 5. Discussion Alloplastic TM TJR aims at restoring function and form of the TMJ and it is indicated in patients diagnosed with wide range of joint pathologies such as ankylosis/re-ankylosis, neoplasia that may require extensive resection of the TMJ, failed autogenous graft, mutilative joint disease among the few.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Graph 1. Assessment of Jaw function (JF), Diet intake consistency (DI) using a Likert Scale and Inter-incisal opening (IO) [In Millimeters, mm] in the preoperative and postoperative phase.
Table 2 Mid-Upper Arm Circumference (MUAC) as reference to assess the nutritional status of the study population in the preoperative and postoperative period [Assessed in Centimeters]. S. No
Variable
MUAC (Pre-op)
MUAC (Post-op, 6th month)
MUAC (Post-op, 12th month)
1 2
Mean Standard Deviation (SD)
20.33 1.104
23.86 2.241
25.83 2.745
3 4
T Value P Value
Comparison of preoperative and 6th post-op month MUAC
Comparison of preoperative and 12th post-op month MUAC
6.32799 < 0.00001
8.31309 < 0.00001
SD: Standard deviation (P < 0.05).
Graph 2. Mid-Upper Arm Circumference as reference to assess the nutritional status among the study population in the preoperative and postoperative phase (In Centimeters, cm).
As observed by Mercuri LG et al. to assess the safety and effectiveness of patient fitted total TMJ reconstruction system patients who underwent implantation of alloplastic TMJ (Techmedia/TMJ concepts) device with a follow-up of 14 years, there was a significant improvement in various parameters such as pain,
mandibular function, diet consistency and QoL postoperatively concluding that patient fitted total TMJ reconstruction system continues to be safe, effective and reliable modality providing long term results [7]. The results obtained in the present study was corelating with the above mentioned study as there was not only
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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improvement in all the subjective and objective parameters assessed but also the custom made alloplastic TMJ prosthesis was cost-effective for the patients who underwent surgery. This was similar to the results observed by Wolford LM et al. [8]. Any surgical procedures can lead to complications at various ˜ o F et al. in their descriptive peri-operative phase. Bricen observational study among patients who received TMJ replacement using custom made alloplastic prosthesis observed various complications such as transitory paresis of facial nerve and myofascial pain syndrome [9] contrary to the complications observed by Jones RH who encountered sensory disturbance to the lip and joint dislocation as complications among his study population [10]. We observed a complication of pre-auricular swelling and pus discharge from the surgical site leading to removal of the device which could be owing to secondary infection in the surgical site and not due to the failure of the alloplastic device as supported by the evidence from the literature where the authors observed among their study population requiring removal of the alloplastic joint was commonly due to infection or heterotopic bone formation and not owing to the device [11,12]. Elledge R et al. conducted a cross-sectional analysis of all the TMJ replacement that was registered in the British Association of TMJ Surgeons (BATS). They observed that there was significant improvements in the mean inter-incisal opening, pain, jaw function, dietary intake, and overall quality of life in the postoperative period as compared to the preoperative period [13]. This was similar to the results observed by Gerbino G et al. [14] from their study where they concluded that single stage resection of the ankylotic mass and total TMJ reconstruction using an alloplastic joint is a safe, effective and reliable modality for establishing long term function. Various studies in the literature have assessed mandibular function, food intake, pain and and overall QoL in patients who undergo TM TJR. But no evidence in literature have assessed nutritional status of patients with restricted mouth opening due to TMJ disease. We have used MUAC as reference to assess nutritional status preoperatively and 6th and 12th using circumference of the right upper arm measuring from the mid-point between tip of the acromium and olecranon process [6]. This parameter can be used to effectively assess the nutrition in patients who had decreased food intake in case of ankylosis and other jaw related disorders. Westermark A observed that some patients gained significant weight post-operatively after TMJ replacement though they did not include it as a parameter in his study [15]. In this study, a partial thickness temporalis flap was preferred over the full thickness muscle flap to cover the alloplastic joint so as to avoid the excessive pre-auricular bulge, which may be unesthetic in the postoperative period. Literature has emphasized the importance of rotational muscle flaps in prosthetic knee joints, which can have implications with regard to the TMJ replacement surgery. In many cases, muscle flaps were used postoperatively to cover the wound dehiscence of prosthetic knee. The results obtained were convincing with decreased failure rates of the joints as it prevents direct communication of the alloplastic joint with the external environment, increases blood supply to the region therefore increases local oxygen concentration, immune-mediator transport, nutrients and metabolic exchanges and antibiotic concentration in the region. It reduces dead space and also creates a conducive biologic environment for the joint [16,17]. Alloplastic DARSN TM Joint Prosthesis by Bhargava D et al. is an all Titanium (Ti) prosthesis constructed considering the biomechanical principles consists of Ti alloy (Grade 5) condylar head and neck with a lateral ramal attachment plate and UHMWPE joint fossa. The neck of the prosthesis is a connector between the condylar head and the lateral ramal attachment plate. The neck is designed to incorporate a slight distal off-set, which places the
condylar head distal to the long axis of the ramal fixation plate. This particular biomechanical design utilizes the advantage of ‘‘Swan neck design’’ which evades the problem of implant-bone interface obstruction faced with right angled designs. UHMWPE fossa acts as an intervening material between the metallic condylar head and the temporal bone to prevent any mechanical damage to the bone during function. All the components are fixed using Grade 5 Ti screws. Screws are round headed with a single slot meant to seat on the counter sink design of the fixation hole after reaching the desired depth in the bone for anchorage [2]. Various evidence in the literature highlights the use of alloplastic TMJ prosthesis for TJR and if the surgery is performed preceding a proper diagnosis and planning yields satisfying results for both the patient as well as the operating surgeon which is agreed from the present study as alloplastic prosthesis does not require a second surgical site as in case of autogenous replacement of the joint [18] and also in support with the fact that it is cost-effective and reliable after follow up period for long term results [19–23]. 6. Conclusion The contemporary designed custom made TMJ prosthesis is biocompatible, cost-effective for TM TJR and found to improve mandibular form and function thereby reducing disability and prevent the need for a donor site surgery in case of an autogenous material thereby reducing the donor site morbidity, hospital stay and patient discomfort. A proper diagnostic work-up and meticulous surgical planning is required before considering the patient for surgery along with the skill of the operator and aseptic precautions during surgery are the factors which yields successful results. From this study, we can conclude that the Total titanium condylar prosthesis with UHMWPE joint fossa design serves as a reliable and safe TM TJR device with significant post-operative results. Funding Self-funded. Disclosure of interest The authors declare that they have no competing interest. Ethical approval Obtained. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from the patients involved in this study. Declaration DARSN TM Joint Prosthesis is developed as a ‘‘Make in India’’ initiative, undertaken as Post-Doctoral research at People’s University, Bhopal and Meenakshi Academy of Higher Education and Research (MAHER), Chennai, INDIA. Design Patent ref 2541/MUM/2015.
Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005
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Please cite this article in press as: Bhargava D, et al. Predictability and Feasibility of Total Alloplastic Temporomandibular Joint Reconstruction using DARSN TM Joint Prosthesis for patients in Indian subcontinent–A prospective clinical study. J Stomatol Oral Maxillofac Surg (2019), https://doi.org/10.1016/j.jormas.2019.06.005