Elsevier

Foot and Ankle Surgery

Volume 23, Issue 3, September 2017, Pages 148-152
Foot and Ankle Surgery

The Rotoglide™ total replacement of the first metatarso-phalangeal joint. A prospective series with 7–15 years clinico-radiological follow-up with survival analysis

https://doi.org/10.1016/j.fas.2017.04.004Get rights and content

Highlights

  • The Rotoglide prosthesis is at present the only uncemented three-piece device with a mobile bearing meniscus used for total replacement of primary osteoarthritis of the first metatarso-phalangeal joint.

  • This prospective series with long-term follow-up documents excellent clinic-radiographic results and a prosthetic survival rate at 15 years of 91,5% (83–100).

  • There were no aseptic loosening. The results are compatible to the best results of arthrodesis for the same condition.

  • Less favorable results were caused by stiffness due to osteoarthritis in the metatarso–sesamoid junction.

Abstract

Background

The Rotoglide total replacement of the MTP-1 joint. 15 years survival analysis. The purpose of this prospective study was to evaluate the long-term performance clinico-radiographically of an uncemented three-component total replacement for the first metatarso-phalangeal joint (MTP-1) used for hallux rigidus (primary osteoarthritis grades 3 and 4). The follow-up was median 11.5 years (7–15).

Methods

The AOFAS forefoot score was used preoperatively and at follow-up. Radiographs were taken weight-bearing in the AP-projection and in tip-toe standing in the lateral view. Arthrosis in the sesamoid junction, prosthetic loosening, subsidence (of prosthesis as well as sesamoids), and dorsiflexion were measured, recorded and subjected to multiple variance analysis. Survival analysis was performed for 15 years.

Material

Ninety implants in 80 patients (53 women and 27 men); median age 58 (41–76) were evaluated.

Results

Six patients representing seven prostheses in situ had died from unrelated reason. The median preoperative AOFAS increased significantly from 40 to 95. The median gain was 45. Four replacements (4.4%) were extracted for other reasons than loosening. No aseptic loosenings were recorded. The survival rate at 15 years was 91.5% (83–100). Multiple variance analysis showed that arthrosis in the metatarso–sesamoid junction correlated with reduced AOFAS score.

Conclusion

The prosthesis has stood the test of time; the results justify its further use.

Introduction

Primary osteoarthritis of the first metatarso-phalangeal joint (MTP-1) is common and gives clinical symptoms already in the fourth and fifth decade of life. Definition of the clinical entity is a painful dorsal collision phenomenon, a dorsal bunion, pain from shoe wear, and severely diminished dorsiflexion in the MTP-1 joint. Lateralization of the loading pattern over the lateral side of the foot and off loading of the great toe is typical and often leads to metatarsalgia. Depending on the radiographic grade of osteoarthritis (1–4) [1], the options for surgical treatment are cheilectomy or osteotomy (grades 1–2) and for grades 3–4 either resection arthroplasy (Keller), arthrodesis or replacement (hemi or total). Replacements have been tried for 50 years [2], [3] using different materials – cemented or uncemented – and with varying degree of success [4], [5], [6]. Based on these results the orthopedic community considers MTP-1 arthrodesis the gold standard for the condition. It relieves pain, but at the expense of movement in the MTP-1 joint and it frequently gives the same lateralization of foot pressure as preoperatively and with results not different from those of osteotomy and cheilectomy [7], [8], [9]. Special shoe wear, MBT shoes or inlay soles are often required. To overcome these shortcomings we have used a three component uncemented total MTP-1 prosthesis for 15 years (Rotoglide™, Implants International, UK) for grade 3 and 4 primary arthrosis, and hereby presents the clinico-radiographic long-term results.

The Rotoglide™ implant (Implants International, Thornaby, Stockton-on-Tees, UK) is a three component device Fig. 1. The prosthesis comes in three interchangeable sizes and with resection and drilling guides. It is at present used in several European countries.

During the period 2000 through 2008 eighty patients with primary arthrosis grade 3 or 4 without hallux valgus or metatarsus primus varus representing 90 Rotoglide implants were operated upon in Fredriksberg Hospital, University of Copenhagen, Denmark. The patients mean age at the index surgery was 58 years (41–76). There were 53 females and 27 males. Six patients representing seven implants in situ had died from unrelated reasons during the follow-up period. Four replacements were extracted (4.4%).

The level of significance was set at 0.05. For comparison of preoperative and follow-up AOFAS scores the Wilcoxon signed rank sum test was used. Multiple variance analysis of the AOFAS score and radiographic findings used the ANOVA test for patients alive with the prosthesis in situ. Visual analog score for pain (VAS) used the same method. For survival analysis the Kaplan–Meier plot was used with the end points deaths with intact prosthesis or prosthetic extraction. The Statistical analyses were performed by an independent investigator (SM)

The study was approved by the local ethical committee (KF 01-251/99)

This has been described in detail elsewhere [12], but it is appropriate to mention that no more than 4–5 mm should be removed from the length of the upper half of the metatarsal head in order not to damage the collateral ligaments. The attachments of the plantar structures on the proximal phalanx should be protected in order to retain joint stability. The resected base of the phalangeal bone is given by the resection guide. During the index surgery the metatarso–sesamoid junction should be checked and if sesamoid bones are not correctly positioned measures should be taken to realign them in the grooves under the metatarsal head. In case of sesamoid arthrosis, fracture or chondromalacia enucleation of the sesamoids could be considered. We did not remove any sesamoids intraoperatively, but nippled off spurs and osteophytes.

The clinical scoring used the AOFAS score [10] preoperatively and at follow-up. The clinical scoring was performed by one of the investigators (LD) who was unaware of the results of the radiographic investigation. All patients with surviving prostheses attended the follow-up. The patients were also asked whether they would have the procedure again and whether they would recommend it or not. Table 1 shows the demographics of the material (gender, age at surgery, time of follow, extraction of prostheses), as well as the clinical results.

A weight-bearing AP projection as well as a tip-toe standing for the lateral view was performed in all available patients. The tip-toe projection is new and allows one to see whether the sesamoids glide or not, and also gives a good judgement of whether sesamoid pathologies are present. In the AP view the inter-metatarsal angle (center lines between metatars 1 and metatars 2 was measured, as well as the hallux angle (center lines between the first metatarsal shaft and the center line of the proximal phalanx (Fig. 2).

The center of the metatarsal head and the midline of the metatarsal shaft in the lateral view constituted one leg. The other leg was the midline of the upper phalanx. The angle between the two lines constituted the dorsiflexion of the joint (Fig. 3). The heel raise was measured as the distance between the lowest point of the calcaneus bone and the ground surface (Fig. 3).

Loosening was defined as more than 2 mm of radiolucency in both planes somewhere around the prosthetic components.

Periprosthetic cysts were measured when found. cm2 was calculated as A = ((d1 + d2)/4)2·Л, where d1 and d2 are length and height of the cyst.

Subluxation of the prosthesis was defined as more than a 2 mm shift from the center of the metatarsal prosthetic components and the meniscus.

Subluxation of the sesamoids was defined as ad latus dislocation of the sesamoid bones of more than 25% from the normal position under the metatarsal head in the standing AP view. In case of doubt the Holly view [11] was used to examine the sesamoid–metatarsal head junction (Fig. 4).

Dislocation of the sesamoid was defined as the entire sesamoid outside the cortical border of the metatarsal head.

Arthrosis of the metatarso–sesamoid junction was said to exist when the joint line between the metatarsal head and the tibial sesamoid in the standing lateral position was obliterated or, was sagged and with osteophytes.

The measurements and the description of the radiographs were performed by (JG) who was unaware of the clinical results.

Section snippets

Results

There was one primary infection, and one late infection after 12 years. The reasons for removal of the implant in the 4 cases were: the two infections, one dislocation of the joint, one technical error (metatarsal head too large leading to a “metallic bunion”). During the follow-up four patients had the tibial sesamoid enucleated due to loading pain. We do not recommend running and jumping for any total replacement in the lower extremity. In spite of that two of our patients were doing half

Discussion

The results of the prosthesis has been reported continuously at international meetings (IFFAS San Francisco 2002, EFAS Copenhagen 2005, AOFAS Boston 2005, First Russian F&A Congress Moscow 2006, DAF Congess Coburg 2008, DAF Congress Berlin 2010, APSFAS Chongqing 2011, COA-EFAS Beijing 2013). These have shown as significant increase in both AOFAS score and dorsiflexion. The current investigation is the first report of long-term results of a three component uncemented mobile bearing total

Conflict of interest

HK originally designed the prosthesis 1994. All rights were transferred to Implants International 1999 without any payment. None of the authors are consultants for Implants International.

There were no conflicts of interest in the preparation of this paper.

Funding

No funding was received for this study.

References (19)

There are more references available in the full text version of this article.

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