First metacarpal resurfacing with polyvinyl alcohol implant in

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Chirurgie de la main 33 (2014) 189–195
Original article
First metacarpal resurfacing with polyvinyl alcohol implant in
rhizarthrosis: Preliminary study
Resurfaçage du premier métacarpien avec un implant en polyvinyle alcoolique dans la
rhizarthrose : étude préliminaire
C. Taleb a,b,*, S. Berner c, G. Mantovani Ruggiero a
a
Hand surgery department, Beneficência Portuguesa de Sao Paulo Hospital, Sao Paulo, Brazil
b
Hand surgery department, University Hospital of Strasbourg, 21075 Illkirch, France
c
Hand surgery department, Sinai Hospital of Baltimore, Maryland, USA
Received 8 July 2013; received in revised form 27 January 2014; accepted 1 March 2014
Available online 20 March 2014
Abstract
Osteoarthritis of first carpometacarpal (CMC) joint is a condition that is frequently encountered in hand surgery. If conservative treatment fails,
several surgical procedures are available ranging from arthroscopic debridement to total joint arthroplasty. This study focuses on a new resurfacing
technique for the base of the first metacarpal using a polyvinyl alcohol hydrogel implant. Our preliminary study found good clinical outcomes and
no inflammatory reaction after a follow-up of 30 months. However prospective studies with a longer follow-up and more patient are needed to
confirm these results.
# 2014 Elsevier Masson SAS. All rights reserved.
Keywords: Basal joint arthritis; Trapeziometacarpal joint; Polyvinyl alcohol implant; Joint resurfacing
Résumé
L’arthrose de l’articulation carpo-métacarpienne du premier rayon (CMC) est une affection fréquente en chirurgie de la main. Après échec d’un
traitement médical, plusieurs gestes chirurgicaux allant du débridement arthroscopique à une arthroplastie totale peuvent être proposés. Ce travail
se concentre sur une nouvelle technique de resurfaçage de la base du premier métacarpien par un implant à base de polyvinyle alcoolique. Cette
étude préliminaire trouve de bons résultats cliniques et aucune réaction inflammatoire à 30 mois de suivi. Cependant, des études prospectives avec
un suivi plus long et comprenant plus de patients sont nécessaires pour évaluer ces résultats.
# 2014 Elsevier Masson SAS. Tous droits réservés.
Mots clés : Rhizarthrose ; Articulation trapézo-métacarpienne ; Implant polyvinyle alcoolique ; Resurfaçage articulaire
1. Introduction
Osteoarthritis is common in the carpometacarpal (CMC)
joint of the thumb. On average, 10% of the population over 50
* Corresponding author. SOS main, CCOM, hôpitaux universitaires de
Strasbourg, 10, avenue Baumann, 67403 Illkirch cedex, France.
E-mail address: chihab.taleb@gmail.com (C. Taleb).
http://dx.doi.org/10.1016/j.main.2014.03.001
1297-3203/# 2014 Elsevier Masson SAS. All rights reserved.
years of age, mostly women, is affected. Primary symptoms
include pain, deformity, loss of mobility and weakness [1]. In
circumstances where appropriate conservative treatment has
failed, surgery may be warranted. Surgical treatments for end
stage CMC (basal joint) arthritis may involve joint fusion, total
or partial trapeziectomy or arthroplasty [2]. Some studies have
shown poor clinical outcomes with first CMC joint fusion [3–5]
and as a consequence, it is seldom performed. Trapeziectomy is
more common and the procedure yields good results. However
C. Taleb et al. / Chirurgie de la main 33 (2014) 189–195
190
Table 1
Patient characteristics.
Casuistique.
Patient
Gender
Age (years)
Side
Dell stage
Eaton stage
1
2
3
4
5
6
7
F
F
F
F
F
F
F
64
65
57
47
51
77
65
Dominant
Dominant
Dominant
Dominant
Dominant
Dominant
Dominant
2
2
2
2
2
2
2
2
3
2
2
2
3
3
several undesirable outcomes have been described, including
thumb shortening, unattractiveness due to residual deformity
and lack of pinch and grip strength. Prosthetic joint replacement
usually preserves both thumb length and strength but
complications such as joint dislocation and implant loosening
may occur.
This study focuses on an innovative less invasive, tissuesparing solution: resurfacing of the base of the first metacarpal
with a polyvinyl alcohol hydrogel (PVA-H) implant.
2. Materials and methods
The senior author (G.M.R.) performed seven resurfacing
procedures of the base of the first metacarpal between February
2008 and November 2009. Table 1 summarizes the patient
characteristics. All were female patients, aged 47 to 77 (average
61 years). The osteoarthritis occurred in the dominant side in all
patients. Four were graded as stage 2 and three as stage 3
according to the Eaton-Littler classification. According to
Dell’s classification, all patients were stage 2 (i.e., metacarpal
subluxation of less than one third of the joint surface). The
Cartiva1 implant (Cartiva Inc., Alpharetta, GA) used in this
series is made of PVA-H and has a predefined shape.
The Cartiva1 implant is an organic polymer-based
biomaterial comprised of 40% polyvinyl alcohol (PVA) and
saline (0.9%). PVA is a synthetic polymer derived from
polyvinyl acetate through partial or full hydroxylation. The
implant’s compressive modulus and coefficient of friction are
close to that of cartilage [6]. It has two concave surfaces that
can smoothly slide against the cartilage. Two diameters are
available: 8 and 10 mm.
The surgical procedure was performed under tourniquet
control with regional anesthesia. A dorsal approach for the
thumb CMC joint was used (Fig. 1). The abductor pollicis
longus and abductor pollicis brevis tendons were detached from
their insertions with a capsular and periosteal flap from the base
of the first metacarpal and its joint surface. The CMC joint was
further exposed and dislocated. The surface of the base of the
first metacarpal was prepared for reaming. A K-wire (1.0 mm)
was inserted into the metacarpal shaft. The K-wire insertion
point into the metacarpal was defined as the approximate center
of the metacarpal joint surface. Because the reamer is the same
height as the implant and we wanted to let the implant protrude
to act as a spacer, we stopped reaming 1–2 mm short of full
depth. The implant was inserted into the reamed area and
stabilization achieved through the implant’s press-fit design.
Fig. 1. Surgical procedure. The carpometacarpal (CMC) joint is exposed after detaching the abductor pollicis longus (APL) and abductor pollicis brevis (APB) (A),
the surface of the first metacarpal is reamed (B) and the implant is impacted (C). Tendons are reattached at the end of the procedure (D).
Technique chirurgicale. L’articulation carpo-métacarpienne est exposé après désinsertion de l’abductor pollicis longus (APL) et de l’abductor pollicis brevis (APB)
(A), la surface articulaire du première métacarpien est préparée (B) et l’implant impacté (C). Les tendons sont réinsérés à la fin de l’intervention (D).
C. Taleb et al. / Chirurgie de la main 33 (2014) 189–195
191
determined using digitized lateral radiographs. The graphic
tools in PowerPoint (Microsoft, Redmond, WA) were used to
draw lines and measure angles on the images, which were
analyzed in random order.
Spearman’s rank correlation coefficient was calculated for
the paired measurements (angle, VAS) to determine if the
implant insertion angle had an effect on the clinical outcome.
Magnetic resonance imaging (MRI) was used at the last followup to determine if the implant caused an inflammatory reaction.
3. Results
Fig. 2. Polyvinyl alcohol hydrogel implant. There are four sizes available
(6 mm, 8 mm, 10 mm and 15 mm), but only the 8 mm size was used in the
current study.
Implant en polyvinyle alcoolique. Il existe 4 tailles différentes : 6, 8, 10 et
15 mm. Dans nos cas, seule la taille 8 mm a été utilisée.
The implant size was chosen based on preoperative X-rays. In
all cases, the medium-size implant (8 mm) was used (Fig. 2).
Before closure, joint stability was assessed by gently applying
stress to the joint. At the end of the procedure, the capsulotendinous flap was repositioned and meticulously repaired
before closing the skin.
Postoperatively, the CMC joint was immobilized in an
abduction splint for six weeks. Complete immobilization was
prescribed during the first three weeks. For the subsequent three
weeks, passive motion with restricted adduction was allowed.
Unrestricted motion was allowed after this period of controlled
motion therapy. Full weight-bearing activities were allowed
after three months.
Assessments consisted of subjective, objective and radiographic data. Subjective evaluations used preoperative and
postoperative Visual Analog Scale (VAS) and Disabilities of
Arm Shoulder Hand (DASH) scores. Physical examination
provided objective measures of preoperative and postoperative
grip strength and the mobility of the operated thumb. Grip
strength and pinch strength were recorded in kilograms. Thumb
motion was evaluated through the ability of the thumb to flex
and adduct towards the head of the fifth metacarpal (Kapandji
score).
Standardized postoperative radiographs including anteriorposterior and lateral views were evaluated to detect CMC
dislocation, implant displacement and bone fracture. The angle
between the implant axis and the first metacarpal axis was
3.1. Clinical evaluation
The outcomes for each patient are shown in Table 2. The
average follow-up period was 30 months (range 23 to 44
months). Mean DASH score improved from 93/100 (78–100)
preoperatively to 40/100 (0–65) at the time of the latest followup. The mean VAS score improved from 8/10 (7–10)
preoperatively to 2/10 (0–5) over the same period, however,
three patients presenting with persistent moderate pain. The
mean grip strength improved from 11 kg (10 kg to 22 kg)
preoperatively to 20 kg (9 kg to 33 kg) at the latest follow-up.
The mean pinch strength improved from 2.4 kg (1.5 kg to 3 kg)
preoperatively to 4.6 kg (2 kg to 6 kg) at the time of the latest
follow-up. All patients were able to flex and adduct their thumb
to the head of the fifth metacarpal (Fig. 3).
3.2. Radiographic evaluation
No radiographic evidence of osteolysis or implant movement was found at the latest follow-up. In two cases, medial
impingement between first metacarpal and trapezium was
observed. No instances of inflammatory reaction to the implants
were identified on the MRI examination.
3.3. Correlation between implant insertion angle and
change in VAS
The Spearman’s correlation coefficient was 0.84. The
hypothesis of independence of the two measures was rejected
(P = 0.017). These data suggest a relationship between the
Table 2
Clinical results.
Résultats cliniques.
Patient
Follow up
(months)
DASH
(out of 100)
Grip strength
(kg)
Pinch strength
(kg)
VAS
(out of 10)
1
2
3
4
5
6
7
44
29
28
28
29
27
23
87/0
87/57
100/56
75/65
100/15
78/36
77/50
15/33
10/9
10/29
5/15
12/24
22/10
5/17
2.5/5.5
1.5/2.5
3/6
2/5.5
3/5.5
2/2
3/5
8/0
7/0
9/4
8/5
8/0
10/3
7/2
DASH: Disabilities of Arm Shoulder Hand; VAS: Visual Analog Scale.
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C. Taleb et al. / Chirurgie de la main 33 (2014) 189–195
Fig. 3. Clinical case: 67-year-old woman with stage 2 osteoarthritis of right thumb according to Littler’s classification. Preoperative and postoperative radiographs
taken 16 months after the surgery. The space created by the implant is visible on the lateral view (A). After 16 months, the thumb mobility is symmetric to the other
side (B).
Cas clinique d’une patiente de 67 ans présentant une arthrose de l’articulation trapézo-métacarpienne droite de stade 2 selon Littler. Clichés radiographiques pré- et
postopératoires réalisés à 16 mois postopératoires. Nous pouvons remarquer l’espace recréé par l’implant sur l’incidence de profil (A). Contrôle à 16 mois
postopératoires. Nous pouvons remarquer une mobilité complète et symétrique du pouce comparée à celle du côté opposé (B).
implant insertion angle and the amount of subsequent pain
reduction as measured by the VAS scale.
3.4. Complications
No cases of infection or instability occurred, and postoperative course was uneventful in all patients.
4. Discussion
The literature tends to divide surgical candidates for
treatment of recalcitrant basal thumb arthritis into two groups:
procedures for Littler’s stage I and procedures for Littler’s stage
II, III and IV [7]. Preventive surgery, such as first metacarpal
osteotomy or volar ligament reconstruction, is performed for
the first group [8]. Salvage surgery, such as trapeziectomy or
total arthroplasty, is indicated for the second group. In the
second group, trapeziectomy, with or without ligament
reconstruction is considered the gold-standard by many
surgeons. Nevertheless, despite good clinical results, many
patients have a lengthy recovery after surgery and impaired
pinch strength [9,10]. A recent study has reported a high rate of
revision after total arthroplasty [11].
One of the emerging surgical trends is the development of
less aggressive procedures for treating basal thumb arthritis and
preserving the bone anatomy. These procedures include
arthroscopic synovectomy and joint debridement in early
stages [10], and partial joint resection with biologic or synthetic
interposition arthroplasty [9]. The obvious goal is to postpone
more definitive, radical procedures. However, the drawback of
these procedures is a potential reaction to the interposed
material. The different types of materials used can be
considered aggressive. Although silicone implants often induce
synovitis, recent studies have shown the opposite [12].
Pyrocarbon implants have recently been used in the trapeziometacarpal joint [13], but the technique is more demanding and
implant dislocation and secondary displacement are common.
Woodward advises performing careful dorsal capsular
reconstruction to prevent subluxation of the pyrocarbon
implant [14].
The joint resurfacing technique described here is consistent
with the current trend, as it is a minimally aggressive procedure
that preserves all the anatomical structures at the CMC joint.
One of the major advantages of this technique is that the joint is
resurfaced with a bone and cartilage friendly, non-reactive
material with compatible biomechanical properties. In the
current procedure, the first metacarpal joint is resurfaced. The
resurfacing implant preserves the trapezium and the length of
the first metacarpal. The implant is made with PVA-H, which is
mechanically similar to cartilage and meniscus [15,16]. Its
hydrophilic cross-linked polar chains retain large amounts of
water without dissolving [17]. Its viscoelastic properties are
close to that of cartilage [18] and the compressive modulus of
PVA-H is similar to the aggregate compressive modulus of
C. Taleb et al. / Chirurgie de la main 33 (2014) 189–195
cartilage [12]. Several studies have demonstrated that the
product is safe and well tolerated by patients [6,19,20].
The results of this first feasibility study after a mean followup of 30 months are satisfactory. Grip and pinch strength were
significantly improved, nearly full range of motion was
achieved and the ability to perform daily activities was
enhanced according to the DASH score. Nonetheless, three
patients still had moderate pain. This may be due to the
implant’s shape and its position. The implant’s shape does not
match the saddle joint configuration of the CMC joint. Since the
implant’s surface is flat, joint congruency may not be optimal.
Even though no implant loosening was observed on both
standard radiographs and MRI, the implant’s shape might cause
subtle instability, thus moderate pain. Also, the position may
have been suboptimal in these three cases. We noticed
impingement between the implant and trapezium recess
(Fig. 4). The erosion between the volar beak of the first
metacarpal and the trapezium recess, where osteoarthritis
typically develops [21], is an area where the implant and
trapezium recess come into contact.
When total arthroplasty is performed on the CMC joint, the
implants are fixed by a long intramedullary stem, which is
inserted into the first metacarpal medullary canal. The position
of the implant stem is defined by the axis of the shaft of the first
metacarpal. To match the anatomical offset of the CMC joint
surface, most implants for this joint have a 20–308 angle
between the articular part and intramedullary part. As these
were our first cases, we had no data on the optimal insertion
angle. The optimal position should cover the largest area of the
joint surface. To attain this goal, the guide and reamer should be
193
inserted in the middle of the joint, perpendicular to the joint
surface.
To determine if the implant positioning affected on the
clinical results, we measured the implant insertion angle in all
seven cases on the lateral X-rays, using the angle between the
axis of the implant and the axis of the first metacarpal bone
(Fig. 5). Patients had better clinical outcomes when the implant
was inserted perpendicular to the joint surface (angle closer to
208) and the worst outcomes when it was inserted parallel to the
metacarpal axis (angle closer to 08). The angle values and the
change in VAS (difference between pre-op VAS and post-op
VAS) for each patient are shown in Fig. 6. The similarity in the
curves indicate the data are correlated, which we tested using
Spearman’s correlation test. Although the sample size was quite
small, the data suggested a relationship between the insertion
angle and the amount of subsequent pain reduction measured
on the VAS scale. Based on these findings, we suggest inserting
the guide for the implant reamer at the center of the joint,
perpendicular to its surface; this will appear as a 208 angle
between the guide and the metacarpal axis on lateral X-rays.
In summary, our study demonstrated the feasibility of
proximal first metacarpal joint resurfacing in early stages of
osteoarthritis. Technical issues aside, the implant seems to be
well tolerated and patients were satisfied overall. Improvements
in both the surgical procedure and the implant shape should
lead to better clinical results including less trapeziometacarpal
joint subluxation. Clinical studies with larger populations
comparing this surgical technique to gold-standard procedures
are needed. Longer follow-up will be necessary to definitely
determine if this procedure is valid.
Fig. 4. Representative case of a 51-year-old right-handed woman with persistent long-standing left basal thumb pain 28 months after surgery. Preoperative
radiographs (A). Postoperative radiograph taken 28 months after surgery; the impingement (red star) is visible between the implant and the trapezium recess. The
implant is not aligned with the trapezium surface (B).
Cas clinique d’une femme droitière de 51 ans avec douleurs persistantes de la base du pouce. Radiographies préopératoires (A). Radiographies postopératoires
prises à 28 mois de recul. Nous pouvons noter le conflit (étoile rouge) entre l’implant et le récessus du trapèze. L’implant ne semble pas faire face à la surface
trapézienne (B).
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C. Taleb et al. / Chirurgie de la main 33 (2014) 189–195
Fig. 5. Measurement of the implant insertion angle in every patient. The blue square represents the implant position, the black line the axis of the metacarpal bone and
the blue line the implant axis. Numbers correspond to the angle between these lines. The sequence of the cases on the figure was different than the one in the tables to
avoid observer bias.
Mesures du positionnement angulaire de l’implant dans nos 7 cas. Le carré bleu représente la position de l’implant, la ligne noire est l’axe du métacarpien et la ligne
bleue l’axe de l’implant. Les numéros correspondent à l’angle entre ces lignes. L’enchaînement des cas sur la figure ne correspond pas à celui dans notre tableau pour
éviter le biais de l’observateur.
Disclosure of interest
C. Taleb and S. Berner declare that they have no conflicts of
interest concerning this article. G. Mantovani Ruggiero is
consultant for Carticept Medical.
References
Fig. 6. Chart correlating the implant insertion angle and the improvement on
the Visual Analog Scale (VAS) score. The same pattern on both curves suggests
the data are correlated.
Graphique corrélant le positionnement angulaire de l’implant et l’amélioration
de score EVA. La même évolution des deux courbes suggère une corrélation
entre ces deux données.
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