Great Toe - Clinical Data

Publications


Implant arthroplasty of the first metatarsalphalangeal joint.

Burks JB.
Arkansas Foot and Ankle Clinic, 1417 West Sixth Street, Little Rock, AR 72201, USA.

Clin Podiatr Med Surg. 2006 Oct;23(4):725-31, vi.

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Abstract
Few topics in foot and ankle surgery incite as much debate as artificial replacement of the great toe joint. As with other implant arthroplasty procedures, such as the hip and knee, the first metatarsalphalangeal joint (MTPJ) has most assuredly had its share of failed designs. This article reviews the shortcoming of non-implant procedures and discusses the advantage of the Arthrosurface system, a new implant that has been used in all major joints to replace degenerative areas and postpone the need for total joint replacement.


Pain Relief and Functional Improvement with Metatarsal Resurfacing in Hallux Rigidus. Preliminary Results in a Multicenter Case Series with a Surgical Alternative to Joint Fusion.

SanGiovanni T, Graf U, Shields N, Hasselman C.
Arthrosurface 2007

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Abstract
Background: First metatarsophalangeal joint degeneration is a common problem leading to esthetical shortcomings, functional limitations, and severe pain in many patients. Surgical treatment options, in particular in the late stage disease process, have been limited and provided mixed results. A novel, anatomic, metatarsal sided resurfacing technology has been recently introduced to the market that allows for intraoperative 3-dimensional mapping of the joint surface geometry and placement of a matching implant. The objective of this investigation is to quantify the effectiveness of the HemiCAP® contoured articular prosthesis in the management of pain and restoration of joint function.
Materials and Methods: Between February 2005 and November 2006, 86 patients with 97 implants underwent metatarsal head resurfacing at four participating institutions. Eleven patients had bilateral implants. Twenty-one patients were male, sixty-five female. The mean age at the time of surgery was 57 years (range 30-74). The mean follow-up was eight months (range 1-20). A population subset allowed for pain and AOFAS scores calculation at baseline and last follow-up. 90% (n=87) had a 15mm diameter implant and 10% (n=10) a 12mm implant.
Results: The mean preoperative AOFAS score improved by 64% from 49.1 (range 27-69) to 80.4 (range 44-95, n=35) at last follow-up; the average baseline pain score improved by 83% from 7.5 (range 2-10) to 1.3 (range 0-7, n=81); passive dorsiflexion improved by 104% from 26 degrees (range: 0-60) before surgery to 53 degrees (range: 25-90, n=97) at the most recent follow-up. The average duration of device implantation (excluding cases with concurrent procedures) was 40 minutes. The most frequent concomitant procedure was correctional proximal phalangeal osteotomy in more than half of the cases. Ninety-four percent of the patients reported very good to excellent results at last follow-up. No device revisions have been performed to date.
Conclusion: Intraoperative mapping of the joint surface geometry permits an anatomic restoration of the metatarsal head. The HemiCAP® system is a joint preserving procedure with minimal removal of bone stock and preservation of healthy cartilage. The surgical technique is reproducible and has a short learning curve. Preliminary results demonstrate excellent pain relief and functional improvement while avoiding end stage joint fusion.


Considerations when Resurfacing the Metatarsophalangeal Joint for Hallux Rigidus: Adjunct Procedures that correlate with the HemiCAP® MTP implant.

Shields N, Hasselman C, SanGiovanni T, Carpenter B.
Arthrosurface 2007
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Resurfacing of the First Metatarsal Head in the Treatment of Hallux Rigidus

Hasselman, Carl T. MD; Shields, Naomi MD

Techniques in Foot & Ankle Surgery: March 2008 - Volume 7 - Issue 1 - pp 31-40
doi: 10.1097/BTF.0b013e318165c356

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Surgical techniques for the treatment of hallux rigidus have evolved during the past decade. Previously, main treatments were cheilectomy for earlier stages of hallux rigidus and resection arthroplasty or arthrodesis for advanced stages. Although arthrodesis has been considered the "gold standard" for advanced hallux rigidus, in younger and more active patients, activity, functional, and shoe wear limitations are undesirable outcomes of this procedure. Alternative surgical procedures have been developed for advanced hallux rigidus, with varying outcomes and complications. Endoprosthetic replacement, which has been well described in the past and revisited recently, has higher complication rates than more traditional approaches. Hemiarthroplasty using various prosthetic resurfacings of the phalangeal base has been reported with variable success rates as well. Soft tissue interpositional arthroplasty has been shown to have inconsistent results and significant stiffness. The Arthrosurface HemiCAP prosthesis has been described for the treatment of full-thickness chondral and osteochondral defects of the shoulder, hip, and knee with high success rates to date. More recently, the technology was expanded to allow for metallic resurfacing of the first metatarsal head as an alternative technique with the potential to maintain motion and function. By using this implant alone or combined with soft tissue interpositional arthroplasty, or proximal phalanx osteotomies, even severe forms of hallux rigidus can be treated. During the past 30 months, the authors have treated more than 100 patients with hemiarthroplasty of the first metatarsophalangeal joint using the HemiCAP prosthesis (Arthrosurface Inc, Franklin, Mass). To date, there have been 2 failures, one from infection and the other from a related procedure. Twenty-five of the first 30 patients with stage II or III hallux rigidus consented to participate in a follow-up study. The mean age of these patients was 51 years. Mean follow-up was 20 months. The mean postoperative increase in range of motion of the joint was 42 degrees (baseline, 23 degrees; postoperative, 65 degrees). The mean American Orthopaedic Foot and Ankle Society and 36-item Short-Form Health Survey Questionnaire scores were 82.1 and 96.1, respectively. All patients were very satisfied with their results and said that they would have the procedure performed again. Although long-term follow-up is still needed, the short-term results are very promising. In addition, future treatment options are maintained because of minimal bone resection at the time of HemiCAP implantation, and conversion to arthrodesis or resection arthroplasty can be performed should the need arise.

HemiCAP® Great Toe Metatarsal Head Resurfacing.
Clinical Monograph, Arthrosurface 2009

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Surgical treatment of hallux rigidus using a metatarsal head resurfacing implant: mid-term follow-up

Carpenter B, Smith J, Motley T, Garrett A.
University of North Texas Health Science Center, John Peter Smith Hospital, Department of Orthopaedics, Fort Worth, TX 76104, USA. bcarpent@jpshealth.org

J Foot Ankle Surg. 2010 Jul-Aug;49(4):321-5.

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The treatment of advanced hallux rigidus remains controversial, with many authors discussing arthrodesis versus arthroplasty. The purpose of this study is to report mid-term outcomes after implantation of a motion-preserving metatarsal head-resurfacing prosthetic and to present our technical considerations and modifications to the published technique to further enhance the clinical benefit of the procedure. Thirty-two implantations were performed in 30 patients. Twenty-three patients were women, 9 men. The average age was 62.8 years (range, 39-86 years). Patients were graded at baseline according to Hattrup and Johnson and completed the American Orthopaedic Foot & Ankle Surgery metatarsophalangeal clinical rating system preoperatively and postoperatively and a patient satisfaction question at final follow-up. Seventy-two percent of implantations were grade III hallux rigidus and 28% were grade II. The average follow-up was 27.3 months (range, 12-43 months). The mean change score for the overall American Orthopaedic Foot & Ankle Surgery scale was 236.8% (SD = 146.62, confidence interval [CI] = 186-287.6). A similar result was achieved between grade II (250.9%, SD = 240.3, CI = 93.9-407.9) and grade III (231.3%, SD = 95.83, CI = 195.14-270.46). No implants were revised or removed, and all patients stated that they were happy with their outcome and would repeat the procedure again if needed. In conclusion, metatarsal head resurfacing in combination with joint decompression, soft tissue mobilization, and debridement can achieve excellent results in grade II and III hallux rigidus. Salvage arthrodesis remains an option if future revisions are indicated.

Late hematogenous infection of first metatarsophalangeal joint replacement: a case presentation.

Stone PA, Barnes ES, Savage T, Paden M.
Presbyterian St. Lukes, Greenwood Village, CO 80218, USA. paulandgailstone@comcast.net

J Foot Ankle Surg. 2010 Sep-Oct;49(5):489.e1-4. Epub 2010 Jun 29.

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Late hematogenous infection of previously asymptomatic orthopedic implants is extremely rare and usually associated with total joint replacements, such as those of the hip or knee. We present the case of an otherwise healthy female who developed a deep space infection 18 months after a first metatarsophalangeal joint implant arthroplasty. The patient presented with pain and swelling at the site, and over the course of several days developed fever and tachycardia and leukocytosis. Cultures of the surrounding soft tissues and the implant grew Streptococcus pneumoniae. The patient reported a 1- to 2-week history of symptoms consistent with an upper respiratory tract infection and it is believed that this distant focus of infection was the probable source of late hematogenous seeding of the first metatarsophalangeal joint implant.

Arthrosurface HemiCAP Resurfacing.

SanGiovanni T
In: Operative Techniques in Orthopaedic Surgery LWW 2010
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HemiCAP® DF MTP Contoured Articular Prosthetic.
Clinical Monograph, Arthrosurface 2010

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1st metatarsal head resurfacing in the treatment of hallux rigidus; a British perspective

Jason Eyre; Nicholas Green; and Simon Budgen

Journal of Bone and Joint Surgery - British Volume, Vol 93-B, Issue SUPP_II, 146.  

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Hallux Rigidus(HR) is a progressive arthritic process of the first MTP joint that causes pain, stiffness anduncomfortable enlargement of the joint, thus resulting in significant morbidity.
Current treatment options include cheilectomy, resection arthroplasty, distal osteotomies (eg Moberg) or arthrodesis (Gold standard). Resurfacing of the metatarsal head, and concurrent joint release allow successful treatment of all stages of Hallux Rigidus, also offering the advantages of maintenance of metatarsal length, and movement.Patients with stage II-IV hallux rigidus, who had failed conservative management, had good bone stock, no previous signs of osteomyelitis and neurovascularly intact status were offered this new procedure. All procedures were performed by the senior author, in a single centre. The HemiCap® MTP prosthesis was implanted using a dorsal approach to the 1st MTPJ. The joint was decompressed and dorsal / lateral bone shaping performed to maximise movement. Pre op and post op scoring at 6 weeks, 3, 6 and 12 months were recorded using AOFAS forefoot, NPS and SF12 scores. 36 First metatarsal head resurfacing procedures were performed on 32 patients. Follow up ranges from 6 weeks to 18 months. Pre op scores averages were AOFAS 22.06 (8–52), SF12 35.55 (14–61.3) and NPS 8.03 (4–10). At 12 months, these average scores had improved significantly to AOFAS 82.57 (55–95) SF12 56.01 (27.5–63.4) and pain scores 0.69 (0–4). There was significant improvement of 60 points on the AOFAS forefoot score, 20 points on the SF12 scoring system, and significant decrease in pain scores of 7.34. Initial results of MTPJ resurfacing are encouraging. This technique provides an advantage over cheilectomy which is of limited use in late stage rigidus, and over resection arthroplasty which shortens the 1st MT and risks transfer metatarsalgia. In our practice metatarsal head resurfacing is providing a useful alternative to fusion in active patients who require movement of the MTPJ. Should patients not tolerate the procedure well, the added advantage is easy conversion to the gold standard of fusion. We continue to follow these patients and add further subjects to this study.


Resurfacing of the First Metatarsal Head for the Treatment of Hallux Rigidus: Evolution of Implant Design, Review of Clinical Experience and Preliminary 5 Year Results of Metatarsal Head Resurfacing.

Hasselman C, Shields N, Carpenter B, SanGiovanni T.

Clinical Monograph, Arthrosurface 2011

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Treatment of advanced stages of Hallux Rigidus remains controversial. Many authors have advocated arthrodesis despite inherent disadvantages associated with the procedure. While joint fusion achieves reproducible pain control, the loss of mobility is not acceptable for many patients especially those with an active lifestyle or profession. Metatarsal head resurfacing has gained increased interest since its inception in 2004. The purpose of this report is to provide a review of the clinical experience gained over the course of 5 years, emphasize technical consideration for improved outcomes, and outline the evolution of design concepts in metatarsophalangeal arthroplasty and resurfacing. Clinical results at 2 to 5 years show remarkable patient acceptance and satisfaction. Pain relief and activity ratings support the concept of a mobility preserving treatment with HemiCAP® resurfacing. The implant screw fixation is a critical strong point in light of previous reports on loosening associated with other arthroplasty procedures.


Hallux Rigidus: First Metatarsal Head Resurfacing

Stone H.

In: International Advances in Foot and Ankle Surgery. Springer 2012

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