The Rotoglide™ total replacement of the first metatarso-phalangeal joint. A prospective series with 7–15 years clinico-radiological follow-up with survival analysis
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.
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Arthrodesis vs arthroplasty for moderate and severe Hallux rigidus: Systematic review
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2019, Fuss und SprunggelenkCitation Excerpt :It has never reached a standard where it could compete with other treatments like osteotomy, cheilectomy, arthroplasty, or arthrodesis [2–6]. The latest results especially of the Roto-Glide (Implants International, Cleveland, UK) have been very promising [7–10]. The aim of the current study was to compare outcome (clinical and pedographic) of total joint replacement with Roto-Glide (TJR) and arthrodesis (A).