Total Prosthetic Replacement of the Temporomandibular Joint (TMJ)

Total Prosthetic Replacement of the Temporomandibular Joint (TMJ)

VERSION CONTROL Version: 2.0 Ratified by: Governing Body Date ratified: 13 November 2013 Name of originator/author: Name of responsible committee: Commissioning with support from public health dental consultant Clinical Quality and Governance Date issued: November 2013 Review date: January 2015 VERSION HISTORY Date Version Comment / Update January 2012 1.0 Version 1 for PCT, January 2012 November 2013 2.0 Version 2 for CCG Page 2 of 8

Contents 1. Introduction... 4 2. Evidence Base... 4 3. Scope... 5 4. Policy... 5 5. Development and Consultation process... 7 6. References... 8 Page 3 of 8

1. Introduction 1.1. The temporomandibular joint (TMJ) is formed between the articular surfaces of the squamous part of the temporal bone of the skull and the condyle (head) of the mandible. 1.2. The TMJ is part of a specialized masticatory apparatus which also includes the jaw musculature and is responsible for the masticatory process. 1.3. Causes of TMJ disease include inflammatory and degenerative arthritis, trauma and complications of surgery. Symptoms include pain and difficulty opening the mouth, and an inability to eat a normal diet. 1.4. Most patients with TMJ diseases are initially treated conservatively with a combination of treatments which may include rest, non-steroidal antiinflammatory drugs and physiotherapy. 1.5. When conservative management is inadequate surgery may be performed. Surgical options include arthroscopic surgery or discectomy and replacement of components of the joint such as the disc, the fossa/socket or the mandibular condyle. Total joint replacement is considered a last resort when other options have failed. 1.6. The procedure is performed under general anaesthesia. Two incisions are made: one in front of the ear where the fossa will be placed and another behind the lower jaw where the condyle will be placed. The coronoid process of the mandible (beak-like process anterior to the joint) is sometimes removed to allow more mobility following surgery. 1.7. The patient may experience facial/jaw swelling and bruising for a few days. They may also have temporary or permanent numbness of the skin and/or facial muscle weakness, nerve injury (this may cause difficulty wrinkling the brow or closing the eyelids tightly). Post-operative management may include physical therapy, bite-splint therapy, restorative or reconstructive dentistry, or muscular therapy with medication or botulinum toxin injections. 2. Evidence Base 2.1. A recently published review of the current knowledge of TMJ total replacement systems suggested that total TMJ replacement interventions showed promising treatment outcomes but there was a need for large multicenter trials to adequately demonstrate the superiority of TMJ replacement over less invasive methodsi. 2.2. An interventional procedure guidance by NICE has indicated that the current evidence on the efficacy of total prosthetic replacement of the TMJ in the short and medium term is adequate but the quantity of evidence on long term efficacy and safety is inadequateii. 2.3. There are no randomised controlled trials on the use of this procedure. The NICE guidance is based on evidence obtained from reviewing literature that included in the main case series, reports from clinical audits and case reports. Page 4 of 8

2.4. The guidance suggests that the procedure should only be undertaken under special arrangements for clinical governance, consent and audit or research. 2.5. Prosthetic replacement of a TMJ is a highly specialised and expensive surgical technique and should only be undertaken by suitably trained and experienced surgeons at specialist centres. The procedure should only be available to carefully selected patients in whom conservative management has failed. An agreed guidance on patient selection for this procedure has been published by the British Association of Maxillofacial Surgeons and outlines the indications and contraindications for this procedureiii. 3. Scope 3.1. The policy applies to patients registered with a Coventry and Rugby General Practitioner General Practitioner (GP) with TMJ disease who require total prosthetic replacement of the joint where conservative management of their condition has failed. 3.2. Implementation of the policy is supported by the NICE guidance on the safety and efficacy of the procedureii and by the guidelines on patient selection produced by the British Association of Maxillofacial Surgeonsiii. 4. Policy 4.1. NHS Coventry and Rugby CCG will only fund the provision of total prosthetic replacement of the TMJ where the patient is a: 1. Patients registered with a Coventry and Rugby General Practitioner And 2. Meets the following criteria: a. Diagnosis: Computed tomogram or magnetic resonance scan as a minimum (not just plain radiographs). b. Prerequisite indication: Failed conservative management (including arthroscopy if possible). c. Indications (usually a combination of the following): i. Pain score >5/10 on a visual analogue scale (combined with any of the others) ii. Dietary scores of <5/10 (liquid score 0; full diet score 10) iii. Restricted mouth opening (< 35mm) iv. Occlusal collapse (anterior open bite or retrusion) v. Excessive condylar resorption and loss of height of vertical ramus vi. Presence of other quality of life issues e.g. difficulty with maintaining the airway, speaking, singing etc. d. Contraindications: i. Local infective process ii. Patient that is severely immunocompromised. iii. Severe coexistent diseases (American Society of Anaesthesiologists Grade III) Page 5 of 8

iv. Partial TMJ reconstruction v. Skeletally immature patients vi. Patients with severe hyper-functional habits (e.g. jaw clenching and teeth grinding) vii. Patients with neurological and mental health conditions who are unwilling or able to follow post-operative care instructions. viii. Known allergic reaction to components of the prosthetic appliance e. The key efficacy outcomes to be achieved should include: i. Pain relief ii. Correction in bite iii. Improved mouth opening iv. Ability to eat a more normal diet 3. Smoking Status: a. Smoking status of patients will be determined and patients will be required to have stopped smoking at least 8 weeks prior to the operation. b. Support is available through the smoking cessation team to help patients stop smoking. 4. Clinicians wishing to provide the treatment for their patients must: a. Inform and get the approval of the clinical governance leads in their Trusts. b. Provide written information on the procedure and any possible complication to the patient/carer. c. Have a discussion about the procedure with the patient which is documented in the notes and obtain a written consent from the patient. d. Obtain prior approval from the CCG before they proceed with any treatment and the patient should be advised that prior approval is required 5. The clinician should carry out an audit and review the clinical outcomes of all patients having total prosthetic replacement of the TMJ. The audit should be conducted in accordance with the NICE audit support tool and an annual report provided to the CCGs. http://guidance.nice.org.uk/ipg329/auditsupport/doc/english 6. Patients should be placed on a national registry and data should be collected on all patients with the aim of providing further evidence on safety and long term efficacy. Page 6 of 8

5. Development and Consultation process 5.1. The following individuals/groups have been involved in the development of this policy, or are key stakeholders: Name of Individual/Group Secondary care clinicians Public Health Consultants Local Dental Committee GP Consortia Leads PCT CEC as part of ratification Representing Acute Services Providers Former: NHS Warwickshire/ NHS Coventry Primary Care Dentists GPs Executive Directors, Non Executive Directors, CEC GPs Page 7 of 8

6. References 1 Guarda-Nardini L, Manfredini D, Ferronato G. Temporomandibular joint total replacement prosthesis: current knowledge and considerations for the future, Int J Oral Maxillofac Surg 2008;37: 103 110. 2 NICE Total prosthetic replacement of the temporomandibular joint (IPG 329), December 2009 3 Sidebottom AJ, Guidelines for the replacement of Temporomandibular joints in the United Kingdom, Br J Oral Maxillofac Surg 2008;46: 146-147 Page 8 of 8