EARLY CLINICAL RESULTS FROM THE EDINBURGH RANDOMISED TOE TRIAL

Joint arthroplasty is increasingly being promoted by commercial companies for hallux rigidus. We report the preliminary results of a randomised controlled trial comparing metatarsophalangeal joint arthroplasty with fusion. 63 patients, 14 with bilateral disease (39f, 24m; mean age 55, range 34–77) were recruited and assessed independently. They were then allocated by closed opaque envelope to receive either a condylar joint replacement (BIOMET®) or toe arthrodesis (circlage and oblique K-wire). Outcome assessments were repeated at 6 months, 1 and 2 years (2 fusion, 1 implant lost to follow-up at 1yr). All 38 fusions finally united (3 were delayed >4 months) at a mean angle of 26±7° dorsiflexion. Two patients were admitted for K-wire extraction under GA and seven required courses of antibiotics. Six of the first 30 arthroplasties had on-going pain and erythema following surgery. One had a sympathetic dystrophy but the remaining five had evidence of phalangeal component loosening and were readmitted for a one stage cemented revision (4 aseptic and 1 septic loosening). The phalangeal component was cemented on the final 9 occasions (Palacos® + Gentamicin). No further revisions have been required. At 1yr 80% of patients rated their fusion and 72% their arthroplasty good/excellent (VAS pain score: pre: 63±18 -v- 59±19, n.s; 1yr: 18±24 -v- 38±27 p Patients are generally pleased to retain joint mobility, but the high incidence of phalangeal component loosening probably will require a change in implant design / surface coating.