Direct skeletal fixation of prostheses using intraosseous transcutaneous implants (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Direct skeletal fixation of prostheses using intraosseous transcutaneous implants

If a leg, arm, finger or thumb has been amputated, or is missing at birth, an artificial substitute (known as a prosthetic limb, prosthetic digit or prosthesis) may be fitted. Prostheses are usually held in place either by suction or by being strapped to the stump of the missing limb or digit. In this procedure, a metal implant is inserted through the skin and into the centre of the bone of the stump. A prosthesis is then attached to the protruding part of the metal implant. The aim is to produce a more comfortable and securely attached prosthesis.


The National Institute for Health and Clinical Excellence is examining direct skeletal fixation of prostheses using intraosseous transcutaneous implants and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute'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 direct skeletal fixation of prostheses using intraosseous transcutaneous implants.

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 preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

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

The process that the Institute 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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 Institute's website (www.nice.org.uk/ipprocessmanual).

NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved.

Closing date for comments: 24 April 2008
Target date for publication of guidance: July 2008


Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

 

1 Provisional recommendations
1.1 Direct skeletal fixation of prostheses using intraosseous transcutaneous implants may have potential advantages for some patients compared with conventional prosthetic sockets. However, current evidence on the safety and efficacy of this procedure is inadequate in quantity and there is a lack of long-term follow-up. Therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2

Clinicians wishing to undertake direct skeletal fixation of prostheses using intraosseous transcutaneous implants 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, in particular with regard to the longer term, and provide them with clear written information. In addition, the use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having direct skeletal fixation of prostheses using intraosseous transcutaneous implants (see section 3.1).
1.3 Patient selection should be carried out by a multidisciplinary team which should include a surgeon experienced in amputation, and rehabilitation specialists, including an expert in prosthetics.
1.4 Further publication of safety and efficacy outcomes will be useful. Clinicians are encouraged to collaborate in the collection and publication of data, particularly in relation to adverse events such as infection and long-term performance of the implants. The Institute may review the procedure upon publication of further evidence.
   
2 The procedure
2.1 Indications and current treatments
2.1.1 In the UK, lower limb amputation is the most common indication for the use of a prosthesis. The most frequent reason for amputation is peripheral arterial disease but other causes include trauma or a tumour. Upper limb or digit amputations are less common and are usually a result of trauma. A small proportion of patients require a prosthesis because of a congenital deficiency.
2.1.2 The type of prosthesis depends on what part of the limb is missing. Conventionally, the prosthesis is attached to the residual stump by belts and cuffs or by suction. The prosthesis usually has a socket, which is custom made from a plaster cast of the stump. One of the main problems with this type of prosthesis is rubbing between the stump and the socket which may cause pain and ulceration. Stump sores are a major limitation for users of conventional prosthetic limbs.    
2.2 Outline of the procedure
2.2.1 The procedure currently has two stages. The first stage involves the insertion of a metal implant into the medullary cavity of the residual bone. The implant has a porous surface and may also have a special coating to help osseointegration. The wound is completely closed and allowed to heal. The second stage of the procedure is undertaken approximately 3-6 months later, when osseointegration has taken place. Part of the implant is surgically exposed and a small metal extension (known as an abutment) is attached to it. The wound is closed with the abutment penetrating the skin, allowing the external prosthesis to be attached to the implant. A period of rehabilitation may subsequently be required, particularly for weight-bearing prostheses.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more details, refer to the Sources of evidence.    
2.3 Efficacy
2.3.1 A non-randomised comparative study of patients with transfemoral amputations, comparing 43 patients treated with a socket prosthesis with 20 patients treated with direct skeletal fixation of a limb prosthesis using an intraosseus transcutaneous implant (osseointegrated prosthesis) reported that 37% (16/43) of patients with a socket prosthesis had restricted hip flexion compared with 0% (0/20) patients with an osseointegrated prosthesis (p value not stated). In the socket prosthesis group, 44% (19/43) had 'moderate trouble' to 'a great deal of trouble' when sitting, compared with 5% (1/20) of the osseointegrated prosthesis group. In a second non-randomised comparative study of 32 upper or lower limb amputees, patients treated with bone-anchored prostheses demonstrated lower sensory thresholds for pressure stimulation of the prosthetic limb compared with patients treated with socket prostheses (4.5 - 4.7 N and 4.7 - 15.8 N, respectively). This reflects improved sensory function with a bone-anchored prosthesis, which may allow more natural functioning and avoid overloading.
2.3.2 In a case series of 11 patients with transfemoral amputations, 9 patients (82%) used their osseointegrated prosthesis all day, every day (mean follow-up period not stated). This study reported that 45% (5/11) of patients had implant abutments replaced because of damage caused by falls. A case series of 3 patients with finger amputations reported that all patients were able to perform normal daily activities using the prosthesis at follow-up periods of 16, 19 and 24 months.
2.3.3 One Specialist Adviser considered a key efficacy outcome to be improved function of patients with high amputations.    
2.4 Safety
2.4.1 In the case series of 11 patients, infection requiring removal of the abutment and implant was reported in 18% (2/11) of patients with transfemoral amputations (each occurring within 1 year). The paper did not give any further details about these patients.
2.4.2 The Specialist Advisers listed anecdotal adverse events including infection and failure at the interface between the skin and the implant, peri-implant bone infections, loosening of the implant fixture, abutment deformity after falls and abutment fracture.
2.5 Other comments  
2.5.1 The Committee noted that the technology for this procedure is continuing to develop and this may influence long-term outcomes.    
   
3 Further information    
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.    

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
March 2008

Appendix: Sources of evidence
 

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • 'Interventional procedure overview of direct skeletal fixation of limb prostheses using intraosseous transcutaneous implants', January 2008

Available from: www.nice.org.uk/ip692overview.

This page was last updated: 30 March 2010