meniscal repair using the fast-fix device in patients with chronic meniscal lesions

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Page 1: Meniscal repair using the FasT-Fix device in patients with chronic meniscal lesions

KNEE

Meniscal repair using the FasT-Fix device in patientswith chronic meniscal lesions

Dragos Popescu Æ Sergi Sastre Æ Miguel Caballero ÆJin Woo Kim Lee Æ Ignasi Claret ÆMontserrat Nunez Æ Luis Lozano

Received: 21 March 2009 / Accepted: 8 September 2009 / Published online: 26 September 2009

� Springer-Verlag 2009

Abstract The aim of this prospective study was to

evaluate meniscal suturing using the FasT-Fix device for

chronic meniscal tears. This procedure was carried out on

25 patients between 2006 and 2007. Nineteen patients were

male and the median age was 31 (14–47) years. The

median waiting time to surgery was 27 (6–80) months and

the median follow-up was 20 (14–29) months. Eleven

patients (44%) required reconstruction of an associated

anterior cruciate ligament (ACL) injury. 20 patients (80%)

showed medial meniscus tears. All tears were located in the

red zone or red–white zone. According to Barett’s criteria,

meniscal tear healing was achieved in 21 patients (84%).

Lysholm and Tegner scale scores improved from 60 (47–

77) preoperatively to 95 (58–100) postoperatively and from

3 (2–6) preoperatively to 6 (3–9) postoperatively, respec-

tively. There were no neurovascular complications. Revi-

sion surgery was necessary in one patient, in whom a

partial meniscectomy was performed. The results obtained

suggest that chronic meniscal tears in the zones described

can be healed.

Keywords Suture � Meniscus � Chronic � Meniscal tear �Meniscal repair � FasT-Fix

Introduction

Meniscal repair has been growing in popularity due, in

part, to the advent of increasingly innovative, simple, and

effective methods, with various meniscal repair techniques

now available, of which the inside-out fixation technique is

considered the gold standard [11]. However, this technique

is associated with increased surgery time, possible techni-

cal difficulties and complications and, above all, neuro-

vascular injuries [2]. The all-inside technique has been a

turning point in the advance of arthroscopic techniques due

to the simplicity of implant insertion and the reduction in

surgery time. Even so, recent studies suggest potential

problems with all-inside systems (especially first-genera-

tion ones) such as chondral injuries or aseptic synovitis. In

addition, significantly lower resistance to load bearing

compared to traditional vertical sutures has been reported,

although its clinical importance is not known [1, 8, 21].

Of the all-inside fixation systems available, we chose the

FasT-Fix device (Smith & Nephew, Inc., Endoscopy

Division, Andover, MA, USA). This system seems to have

better biomechanical properties, is technically simpler and

presents fewer complications in comparison to other

devices [6, 7, 13, 17]. Several recent prospective studies

report suture success rates of 83–90% [3, 10, 15].

We hypothesized that good results can be obtained in

meniscal repair of chronic meniscal tears. Therefore, the

D. Popescu � S. Sastre (&) � M. Nunez � L. Lozano

Knee Unit, Department of Orthopedic and Trauma Surgery,

Hospital Clınic, C/Vilarroell 170, 08036 Barcelona, Spain

e-mail: [email protected]

D. Popescu

e-mail: [email protected]

M. Caballero

Surgery Department, IDIBAPS, University of Barcelona,

Barcelona, Spain

J. W. K. Lee

Department of Orthopedic and Trauma Surgery,

Hospital ISSSTE Valentın Gomez Farias, Gaudalajara, Mexico

I. Claret

Department of Orthopedic and Trauma Surgery,

Hospital Esperit Sant, Barcelona, Spain

123

Knee Surg Sports Traumatol Arthrosc (2010) 18:546–550

DOI 10.1007/s00167-009-0926-6

Page 2: Meniscal repair using the FasT-Fix device in patients with chronic meniscal lesions

purpose of the present study was to evaluate the clinical

results obtained of the repair of chronic meniscal tears

using the FasT-Fix device.

Material and Method

Patients

Patients undergoing repair of chronic meniscal tears during

2006 and 2007 were included. All patients had meniscal

symptoms (interarticular line tenderness, positive

McMurray test ± locking) prior to surgery. No surgery

was carried out in asymptomatic patients with a positive

MRI signal. All patients requiring ACL reconstruction had

meniscal symptoms (positive Lachman test, anterior

drawer, or pivot-shift) in addition to signs of clinical

instability. Inclusion criteria were: vertical tear along the

entire width of the meniscus of at least 1 cm in length,

location in the red zone or red/white zone of the meniscus

(less than 6 mm from the periphery), no signs of meniscal

degeneration, and age \50 years. Patients with meniscal

degeneration, radial rupture, multiple bucket-handle tears,

or intrameniscal tear were excluded. Complete ACL tears

were reconstructed during the same surgery and were not

an exclusion criterion. No cartilage repair was carried out.

Surgical technique

All meniscal repairs were performed by the same surgeon

(S.S.). After evaluating the meniscal tear and determining

that all inclusion criteria were met, the edges of the tear

were debrided using an arthroscopic oscillating motor.

Subsequently, perforations were made in the meniscal wall

using a spinal needle to facilitate postoperative bleeding.

All sutures were horizontal (Fig. 1), and the insertion depth

for the anchors was 10–12 mm for the lateral meniscus

(LM) and 12–14 mm for the medial meniscus (MM),

depending on the location of the injury (the posterior horn

or body, respectively), in order to protect the neurovascular

structures. The needle was inserted through the appropriate

portal using the protector split plastic cannula. The FasT-

Fix device delivery needle was positioned so that it per-

pendicularly pierced the surface of the inner meniscal

fragment. The delivery needle was then advanced into the

peripheral meniscal fragment to the end of the depth lim-

iter. The delivery needle was then rotated slightly and

pulled out of the meniscus, releasing the first anchor within

the meniscus. The second anchor was then advanced for-

ward in the delivery needle by sliding the device trigger

forward, and a second implant was inserted approximately

5 mm from the first one. After two anchors had been

inserted, the delivery needle was removed from the

Fig. 1 Step-by-step images showing the suture of a posterior horn of a medial meniscus of a right knee. a Identification of the tear,

b–d introduction of the anchors, e tightening of the knot, f confirmation of a stable suture

Knee Surg Sports Traumatol Arthrosc (2010) 18:546–550 547

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Page 3: Meniscal repair using the FasT-Fix device in patients with chronic meniscal lesions

meniscus and the free end of the suture was pulled to

advance the sliding knot, thereby providing meniscal tear

fixation. The knot was further secured and the suture ends

were cut with the FasT-Fix Knot Pusher and Suture Cutter.

The space between the two anchors was about 4–5 mm, so

that in a smaller tear (about 1 cm long), only one device,

placed horizontally in the center of the tear, was necessary.

In the case of an associated ACL tear a reconstruction was

performed using the autologous hamstring tendons.

During the immediate postoperative period, isometric

exercises were carried out and an orthesis was placed on

the patient to limit their flexion to 60� during the first

3 weeks, as well as allowing partial axial load bearing with

the use of crutches. After the 3rd week, the flexion limit

was raised to 110� and full weight bearing was allowed.

Assessments

All postoperative assessments were carried out by a sur-

geon (D.P.). The Barett’s criteria [4] were used to evaluate

the healing process for a meniscal rupture. A meniscal tear

is considered to be healed when none of the following signs

are present: pain at the interarticular line, joint effusion,

locking or a positive meniscal test. Diagnosis of the men-

iscal tear all the patients was determined by clinical

examination and confirmed with magnetic resonance

imaging (MRI) preoperatively. Lysholm and Tegner

functional scales [22] were used both during the preoper-

ative period and the follow-up.

We also evaluated the grade of satisfaction of the patient

with an arbitrary scale (1—unsatisfied, 2—quite unsatis-

fied, 3—more or less satisfied, 4—satisfied, 5—highly

satisfied) and the return to previous levels of activity.

An MRI control after the surgery was not performed

unless clinical evaluation suggested a failure of the meni-

scal repair.

Statistical methods

The Lysholm activity scale score had a normal distribution

(Shapiro–Wilk test; P [ 0.05) for the whole group and the

subgroups (ACL reconstruction or not). The t test for

paired samples was used. The correlation between chro-

nicity of the tear and preoperative/postoperative difference

of Lysholm score was calculated using Pearson’s test. The

Tegner scale scores were analysed using the non-para-

metric Wilcoxon signed-rank test for paired samples.

P values \0.05 were considered statistically significant.

Data are presented as median (range) unless otherwise

stated. The statistical analysis was performed using the

SPSS v16.0 for Windows (SPSS Inc., Chicago, IL, USA)

software.

Results

Between 2006 and 2007, 25 meniscal tears were repaired in

25 patients using the FasT-Fix device. All were chronic

tears ([3 months), with a waiting time between injury and

surgery of 27 months (range 6–80). Due to the specific

characteristics of our hospital, waiting lists for this type of

surgery are long. The patients were not professional ath-

letes but rather people who occasionally participate in

sports. The median age was 31 years (range 14–47) and

there were 19 men and 6 women. The cause of injury was

sports-related in 15 patients, a car accident in 6, and in the

remaining 4 there was no obvious prior trauma.

Twenty patients had tears of the MM (11 posterior horn

and 9 posterior horn and body) and five of the LM (4

posterior horn and 1 posterior horn and body). The meni-

scal tear was associated with a partial ACL tear in 2

patients and with total ACL rupture in 10 patients; 11

(44%) patients required ACL reconstruction. A mean of 1.7

FasT-Fix devices were used (1 device in 12 patients, 2 in

9 patients, 3 in 2 patients, and 4 devices in 2 patients).

All sutures were horizontal. There were no neurovascular

complications. The median follow-up was 20 months

(range 14–29) and, according to strict Barett’s criteria,

meniscal tear healing was achieved in 21 patients (84%).

The Lysholm score improved from 60 (range 47–77)

preoperatively to 95 (range 58–100) postoperatively

(P \ 0.001) and the Tegner score improved from 3 (range

2–6) preoperatively to 6 (range 3–9) postoperatively

(P \ 0.001). Significant improvements were also found in

the groups of patients with meniscal tear alone and those

with associated ACL reconstruction. Better functional

results were found in the group with associated ACL

reconstruction (P \ 0.05). No differences in functional

results were found according to repair of MM or LM.

No significant correlation was found between the chro-

nicity of tear and the Lysholm score in the whole group,

meniscal tear alone or associated with ACL reconstruction

(P = 0.24, 0.72, and 0.49, respectively).

Positive Barett’s criteria were observed in four patients;

three with meniscal tear alone and one with associated

ACL reconstruction. The time between tear and surgery

was 14, 23, 12, and 15 months, respectively, in these four

patients, with no significant correlation with failure

(P = 0.02), and the preoperative and postoperative’s Lys-

holm scores were 53, 58, 60, and 60 and 75, 78, 58, and 89,

respectively (the third score was of the patient who

underwent revision surgery). One patient (with MM tear

alone that required 3 FasT-Fix sutures and with a time

between tear and surgery of 15 months) presented joint line

tenderness and a positive McMurray’s test. The MRI

confirmed the failure of the suture. The patient was oper-

ated on again 14 months later, when suture failure was

548 Knee Surg Sports Traumatol Arthrosc (2010) 18:546–550

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Page 4: Meniscal repair using the FasT-Fix device in patients with chronic meniscal lesions

confirmed and a partial meniscectomy was performed.

Three patients reported pain during meniscal provocation

tests which did not affect activities of daily living. In one of

these three patients (with meniscal repair alone) MRI

confirmed suture failure, while the images were not con-

clusive in the two other patients.

Patient satisfaction with the surgical intervention was:

20 patients highly satisfied, 4 more or less satisfied, and

1 patient unsatisfied (the same patient who underwent a

second surgery).

Twenty patients (80%) were able to recover the same

physical activity level they had prior to injury.

Discussion

The most important finding of this study was the good

results obtained with meniscal repairs in chronic meniscal

lesions. There are numerous reports of meniscal repair

outcomes. Lozano et al. [16], in a recent review, found

that the suture success rate varied between 57 and 100%,

depending on the technique or devices used, but warned

that there was a wide discrepancy between the healing

criteria used in different studies and that this probably

affected the results obtained. Unfortunately, this review

did not consider whether the period elapsed from injury

to surgery affected clinical outcome. The majority of

reports concern acute tears and some include tears with

longer waiting times [5, 9, 12, 15]. Studies differ with

respect to the effect of the length of waiting time on

outcomes, although the general opinion seems to be that

acute tears evolve better clinically than chronic ones.

Neither is there agreement on where to set the limit

between chronic and acute injuries: some studies suggest

3 weeks, while others suggest 6 weeks or even 3 months

[5, 9, 15].

Only one report was found on chronic meniscal tear

repairs alone [18]. This was a short-term retrospective

study of the outcomes of 27 meniscal repairs (25 patients)

with chronic tears and a waiting time around 25 months.

A significant clinical improvement was achieved in 21

patients according to the Lysholm, Tegner, and IKDC

scores. Kotsovolos et al. [15], in a prospective series,

studied the results of 61 FasT-Fix meniscal repairs, of

which 31 (52%) were chronic tears ([3 weeks), using the

Barett criteria for meniscal healing. The authors found no

significant differences between the clinical results of acute

and chronic injuries. Kalliakmanis et al. [12], in a retro-

spective study of 280 meniscal repairs (59.6% in chronic

tears) associated with ACL reconstruction, compared the

effectiveness of various suture devices (T-Fix, RapidLoc,

FasT-Fix) and concluded that the clinical results were

similar, with no differences when injuries were [3 weeks

old (success rate of 91.1% in acute and 89.2% in chronic

injuries according to Barett criteria). Billante et al. [5] in a

study of 38 meniscal repairs (11 chronic) using the Rap-

idLoc PDS obtained a success rate of 84% in acute and

92% in chronic injuries.

Despite the chronic nature of the meniscal injuries

included in our study, the success rate was similar to that

of other reports. We suggest this is due to careful prep-

aration of the suture site and correct positioning of the

implants. Currently, vertical positioning of suture stitches

is recommended. In the majority of biomechanical studies

supporting this option, the sutures performed with dif-

ferent devices were subject to distraction forces [6, 7, 13,

17, 20]. Zantop et al. [23] found that horizontal sutures

showed better resistance to shear forces, which are more

like the real forces the meniscus is subject to in vivo.

Other advantages of the horizontal suture are the ease of

insertion and the wider suture length, which covers a

greater area of the torn meniscus [14]. However, there is

probably more evidence supporting vertical sutures and

the technique used remains at the discretion of the

surgeon.

These positive clinical results do not always correlate

with complete healing. According to Henning [11], com-

plete healing occurs when the entire meniscal breadth

(100%) has healed; partial healing occurs when more than

half of the breadth is healed (50–100%). Failure occurs

when less than half of the meniscal breadth heals. There are

various methods of examining the anatomical appearance

of meniscal healing: arthrography, arthro-CT scan, arthro-

NMR or arthroscopic revision. Pujol et al. [19], in a liter-

ature review, found that complete meniscal healing

occurred in between 42 and 88% of cases. Complete

healing occurred in between 73 and 88% of cases in studies

using control arthroscopy (second-look) and in between 45

and 59% in studies using arthrography or arthro-CT scan,

suggesting that despite the similarities in the surgical pro-

cedures used, there is still a discrepancy between arthro-

scopic and arthrographic results. Partial healing occurs

quite often but is accompanied by a stable, painless

meniscus.

The present study is clearly limited by the relatively low

number of patients and the lack of a control group (acute

meniscal tears). As mentioned, due to the characteristics of

our hospital, patients are only seen by an orthopedic sur-

geon months after their injury and it is almost impossible

to operate on acute meniscal tears. On the other hand, the

follow-up is short. In addition, in this group of patients

with chronic tears, long-term results, especially with

regard to probable degeneration of the meniscus, are

required. Larger series and medium-long-term prospective

follow-ups are needed in order to reach definitive

conclusions.

Knee Surg Sports Traumatol Arthrosc (2010) 18:546–550 549

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Page 5: Meniscal repair using the FasT-Fix device in patients with chronic meniscal lesions

Conclusion

The positive clinical results obtained, despite the chronic

nature of the meniscal tear, rule out the idea that long

waiting times between tear and surgery are contraindicated

for performing meniscal repair. If the meniscal tear com-

plies with the criteria mentioned, with careful preparation

of the suture site, correct surgical techniques and rehabil-

itation, we suggest the meniscus should be preserved,

which could result in long-term benefits.

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