Interventional Procedures Consultation Document - Metatarsal phalangeal joint replacement of the hallux

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Metatarsophalangeal joint replacement of the hallux

The National Institute for Health and Clinical Excellence is examining metatarsophalangeal joint replacement of the hallux and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about metatarsophalangeal joint replacement of the hallux.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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

Closing date for comments: 21 June 2005
Target date for publication of guidance: September 2005


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

Current evidence on the safety and efficacy of metatarsophalangeal joint replacement of the hallux appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

1.2 Clinicians should ensure that patients fully understand the uncertainties about the place of this procedure in relation to alternative treatment options (for example, arthrodesis). They should be provided with clear written information and, in addition, use of the Institute's Information for the public is recommended.
1.3 Patient selection is important, and should take into consideration the likely intensity and duration of use of the joint based on the patient's activities and aspirations.
1.4

Further research will be useful in establishing the long-term outcomes of different types of prosthesis.


2 The procedure
2.1 Indications
2.1.1

Osteoarthritis and rheumatoid arthritis commonly affect the metatarsophalangeal (MTP) joint at the base of the big toe. The joint may become predominantly stiff (hallux rigidus) or deformed (hallux valgus).

2.1.2 Conservative treatments include exercise, physiotherapy, analgesics, non-steroidal anti-inflammatory tablets or cream, and steroid injections into the joint. Surgery may be required in patients with severe symptoms that do not respond to conservative measures. The main surgical options are fusion of the joint (arthrodesis), simple excision of the joint (Keller's procedure) and joint replacement with an artificial implant.
2.2 Outline of the procedure
2.2.1 MTP joint replacement is carried out under general or regional anaesthesia using tourniquet control. An incision is made over the joint and the capsule is exposed by dividing tissue and retracting tendon. The joint surfaces are excised and the medullary canals of the first metatarsal and proximal phalanx are reamed to accommodate the prosthetic joint implant. A preliminary reduction with a trial implant is done to ensure a snug fit and the implant components are then placed in each canal. The joint capsule is closed and a flexible splint is used postoperatively to maintain the correct position.
2.3 Efficacy
2.3.1

The main outcome measures reported were pain relief and patient satisfaction. Three studies reported that 73% (8/11), 79% (46/58) and 100% (7/7) of joints with implants were pain-free after mean follow-ups of 17 months, 12 years and 35 months respectively. Another study including 86 implants reported a statistically significant improvement in pain scores after the procedure. Two further studies reported pain relief in 66% (59/90) of implants and 94% (30/32) of patients (mean follow-ups of 3 years and 8 years respectively).

2.3.2

Four studies reported that between 74% (29/39) and 88% (7/8) of patients were completely satisfied with the procedure (mean follow-ups of 12 months and 17 months respectively). For more details, refer to the sources of evidence (see Appendix).

2.3.3 Most of the Specialist Advisors stated that this was an established technique. However, there is limited evidence on the durability of the newer implants.
2.4 Safety
2.4.1

The main complication reported was the formation of osteophytes around the implant. This affected between 4% (2/49) and 71% (41/58) of implants. Fractures were seen radiologically in 0% (0/106) to 29% (21/73) of implants, and frequency of fracture was related to the length of time that the implant had been in place. At the follow-up assessment, between 0% (0/11) and 8% (3/37) of implants had needed to be removed (mean follow-ups of 17 months and 70 months respectively). Other complications included mal-positioning of the implant, infection, inflammation, dislocation and persistent pain. For more details, refer to the sources of evidence (see Appendix)

2.4.2 The Specialist Advisors stated that potential adverse events included persistent pain, infection, implant loosening, implant fracture, osteolysis, bone over-production, cyst formation, silastic granulomas and transfer metatarsalgia. Some of these complications may necessitate removal of the joint.
2.5 Other comments
2.5.1 Radiological follow-up may demonstrate fracture of protheses or immobility of joints in the long term. However, the influence of these changes on symptom relief remains unclear.
3 Further information
3.1 In 2002 and 2004 the Medicines and Healthcare products Regulatory Agency (MHRA) issued the following device alert notices: MDA DA2002(03), Screw-Fit Ceramic Toe Joint (Metatarsophalangeal) Replacement Prosthesis and MDA/2004/009, Moje Press-Fit Ceramic Toe Joint Prosthesis

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
June 2005

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 metatarsophalangeal joint replacement of the hallux, February 2005

Available from: www.nice.org.uk/ip282overview

This page was last updated: 04 February 2011