Interventional procedure consultation document

Insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction

Inserting a titanium implant that is not covered by soft tissue for orofacial reconstruction

Titanium implants can be inserted to replace bones in the face as part of orofacial reconstruction, that is, rebuilding the facial skeleton after severe damage or deformity. This is most commonly needed after injury or surgery to remove tumours, or to treat deformities of the face that may have been present from birth.

In this procedure, the implants are customised (made specially to fit the person). An accurate model is made of the bones of the person’s face. The model is used as a template to make the implant, which is then fixed in position using titanium screws during an operation. The implant is not covered by soft tissue.

The National Institute for Health and Clinical Excellence (NICE) is examining  insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 23 April 2013

Target date for publication of guidance: 24 July 2013

1                      Provisional recommendations

This guidance only covers the use of titanium implants for complex orofacial reconstruction, often involving multiple surfaces, including bony and cartilaginous structures, without soft tissue cover or the expectation of substantial soft tissue cover. It does not cover the use of titanium implants for orofacial reconstruction where the implants are covered or expected to become substantially covered with soft tissue.

1.1                  Current evidence on the efficacy of inserting customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction is based on very small numbers of patients. With regard to safety there is concern about the risk of recurrent infection and other complications resulting from long-term exposure of the implants. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2                  Clinicians wishing to undertake insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction should take the following actions.

• Inform the clinical governance leads in their trusts.
• Ensure that patients understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for the public [[URL to be added at publication]] is recommended.
• Audit and review clinical outcomes of all patients having insertion of customised exposed titanium implants, without soft tissue cover, for complex orofacial reconstruction.

1.3                  Patient selection is of fundamental importance. The procedure should only be offered to patients for whom there are no other options for reconstruction after consideration by head and neck surgeons and plastic surgeons.

2                      Indications and current treatments

2.1                  Complex orofacial reconstruction involving multiple surfaces, including bony and cartilaginous structures, without the expectation of substantial soft tissue cover is most frequently needed after severe orofacial trauma or removal of orofacial tumours, but may also be used to treat congenital facial abnormalities. Various materials are used including autologous grafts; tissue-engineered bone; alloplastic materials such as silicone, titanium or hydroxyapatite; and composites (for example, titanium mesh embedded in porous polyethylene).

2.2                  The traditional method of forming titanium implants for complex orofacial reconstruction is to bend and cut titanium mesh during the operation. Positioning the implant in the appropriate site requires an accurate assessment of shape and fit, and a number of insertion attempts may be necessary before correct implant shape is achieved. In this procedure, computer-aided design and computer-aided manufacturing (CAD-CAM) techniques are used to create a customised implant before the operation to insert the implant. The aim is to improve both functional and cosmetic outcomes.

3                      The procedure

3.1                  The design and construction of custom-made implants can be achieved by a number of different techniques. In most cases, customised implants are designed and manufactured using CT scan data by CAD-CAM and 3-dimensional printing techniques. In some cases a model is constructed on which the implant is shaped and made, either directly or indirectly.

3.2                  With the patient under general anaesthesia the sterilised titanium implant is fixed to adjacent bone using titanium screws. Precise details of the operation will depend on where the implant is to be used and the integrity of surrounding structures.

4                      Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

4.1                  A case series of 14 patients who had undergone reconstruction procedures following removal of head and neck tumours reported that the maxilla, hemimandible and nose were successfully reconstructed without needing to raise flaps for coverage. Attempts to reconstruct the subtotal mandible in 2 patients failed because of lack of soft tissue adherence. Both patients underwent further conventional procedures after the implants were removed.

4.2                  In the case series of 14 patients, appearance was described as excellent in 3 patients (details of appearance were not described for the remaining patients). After 2 years of follow-up, all patients remained disease-free and had an acceptable quality of life.

4.3                  The Specialist Advisers listed key efficacy outcomes as reduced operating time, reduced morbidity, long-term implant retention rates, fixation (screw) removal rates and survival rates (for patients with cancer).

5                      Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

5.1                  Ulceration through the skin of titanium-coated hollow screw reconstruction plate (THORP) implants was reported in all patients with buccal placement of plates in the case series of 14 patients. Eight patients had been treated using THORP but it was not reported how many of them had buccal placement of the implant. It was noted that 1 patient was treated by fitting an acrylic cover plate over the exposed section of the THORP implant. Case reports described unintentional implant exposure in 2 patients that occurred after insertion of large titanium implants for nasal reconstruction. Both patients needed a number of additional procedures.

5.2                  Infection due to methicillin-resistant Staphylococcus aureus (MRSA) resulting in removal of the implant was reported in 1 patient in the case series of 14 patients.

5.3                  Fistulae were reported in 4 patients in the case series of 14 patients. Two of the fistulae were closed with relatively simple flap procedures, and a third was closed using adjuvant hyperbaric oxygen therapy. The fourth fistula was found after 2 years at the site of one of the rivet heads on the THORP implant. This orocervical fistula failed to close after 4 flap procedures and hyperbaric oxygen therapy; eventually titanium chain mail with a solid titanium diaphragm was used to close it.

5.4                  The Specialist Advisers listed theoretical adverse events as recurrent infection, bone infection, possible septicaemia, externalisation, bone resorption, loosening of the implant, poor aesthetics and failure of the prosthesis.

6                      Further information

6.1                  This guidance is a partial review of ‘Exposed customised titanium implants for orofacial reconstruction’ NICE interventional procedure guidance 28 (2003).

6.2                  For related NICE guidance see the NICE website.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

March 2013