Problems with TOEFIT-PLUS™ prosthesis for hallux rigidus

NewsBot · May 9, 2017

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Outcome following First Metatarsophalangeal Joint Replacement using TOEFIT-PLUS™: a Mid Term Alert
Andrew G. Titchener, Nicholas S. Duncan, Rohan A. Rajan
Foot and Ankle Surgery, Articles in Press

Highlights
•We examine mid-term results of the Toefit-Plus™ Metatarsophalangal prosthesis.
•Unacceptably high revision rate; 24% at 33 months post surgery.
•We have abandoned use of this prosthesis.
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Background
We aim to evaluate the mid-term results of first metatarsophalangeal joint replacement for hallux rigidus using Toefit-Plus™ in a single surgeon series.

Methods
We prospectively studied the outcomes of 86 toes in 73 patients using the AOFAS-HMI score and radiological follow up. The mean follow up was 33 months (2-72). Ten patients have been lost to follow up.

Results
Eight patients sustained intraoperative fractures or impending fractures requiring circlage wiring. 18 joints have either been revised or listed for revision giving a revision rate of 24%; this occurred at a mean of 33 months post-surgery.

Conclusions
First MTPJ replacement is an option in hallux rigidus and patients who are not revised experience significant improvement in AOFAS scores in the medium term. We have previously published satisfactory results with this prosthesis. However the revision rate is unacceptably high and we have discontinued its use completely. Future design evolutions should address the issue of osteointegration on the phalangeal side.
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Admin2 · Nov 9, 2014

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NewsBot · May 8, 2017

Long Term Results of the Toefit-Plus Replacement for First Metatarsophalangeal Joint Arthritis
Shreekant Gupta et al
The Foot; Article in Press

Highlights
•55 cases of arthritis of metatarsophalangeal joints treated surgically with Toe fit replacement of joint.
•Long term follow up (average 134 months) results review.
•High rate of revision, 34% poor results and 18% had removal of implants and revision surgery.
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Hallux rigidus is osteoarthritis affecting the metatarsophalangeal joint of the first toe. Patients often complain of pain and stiffness with pain being aggravated by walking, particularly during toe-off in the gait cycle. Osteoarthritis of the metatarsophalangeal joint is commonly treated with arthrodesis or resection arthroplasty. Metallic replacement of this joint is used sometimes but is not widely accepted. The use of silastic joints has problems with synovitis and implant failure. The authors used titanium implants, which can be screwed into the metatarsal and phalanx, allowing good fixation without the use of bone cement. Release of the tight plantar capsule and tissues is necessary to achieve better range of movement and correct implant positioning.

Fifty five cases of arthritis of the first metatarsophalangeal joint were treated surgically with Toefit-Plus™ joint replacement. The implant consists of both metatarsal and phalangal components and a fixed-bearing polyethylene insert. All patients had a release of tight soft tissues on the plantar side. Follow up occurred at 84 to 144 months after surgery (mean of 134 months), and the results showed increasing numbers of implant failures and revisions (21%) of Toefit-Plus™ implants. 47 patients were available for review. Twenty four (51%) out of 47 patients reported satisfactory results with Toefit-Plus™ arthroplasty. Ten of these patients (21%) had removal of implants and further surgical procedures were needed due to implant failure. Eleven (23%) out of 47 patients still complained of pain despite having joint replacement with the Toefit-Plus ™ implant.

There is a high rate of complications with the Toefit-Plus™ implant resulting in revision surgery. Patients should have the risks associated with arthroplasty clearly explained, including the risk of revision, and the option of arthrodesis should be discussed when planning surgery. Further trials and redesign of implants may help to improve results. We would not recommend the Toefit-Plus ™ implant due to poor results seen in one third of patients.
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