Clinical Use of the Meniscal Scaffold



Fig. 30.1
CMI (a, b) macroscopic appearance, (c) ultrastructure



Actifit-Orteq. UK (Fig. 30.2): This is a synthetic biodegradable scaffold, composed of polycaprolactone-polyurethane which has been available since 2008. This structure seems to have different mechanical properties so as to be more resistant to handling during the surgical procedure and to joint loads. Moreover, the increased absorption rate should allow a complete tissue regeneration.

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Fig. 30.2
Actifit (a, b) macroscopic appearance, (c) ultrastructure

The ultrastructure of the scaffold presents 80% porosity is composed of soft segments for 80% and of more rigid urethane segments for the remaining 20%.

The degradation starts with hydrolysis of polycaprolactone which lasts up to 5 years, while the urethane segments are removed by macrophages and giant cells and are integrated into the surrounding tissues [9, 10].


30.1 Clinical Indications


The indication for the scaffold implantation, which is widely accepted, is pain after previous meniscectomy. The prophylactic use of the scaffold is still being debated.

Rodkey et al. [11] in a multicentric randomized study, regarding 311 patients with irreparable meniscal tear or pain after previous meniscectomy, demonstrated that the collagen meniscus implant is useful in replacing irreparable or lost meniscal tissue in patients with a chronic meniscal injury. The implant was not found to have any benefit for patients with an acute injury.

In one of our studies [12] about the CMI results at 5 years follow-up, a tendency for a better outcome in patients with acute lesions was observed, and Hirschmann et al. [13] reported that patients who underwent CMI due to prophylactic reasons had a higher Tegner score at one-year follow-up than the others.

Filardo et al. [14] speculated that this dispute could depend on the rapid clinical improvement offered by meniscectomy which makes the benefits of the scaffold implantation less significant in a short time. Probably, the meniscus protective role requires a longer time to be clinically evident. Long-term studies on acute injury will clarify this problem.

For a successful scaffold implantation, the anterior, posterior meniscal horn and peripheral rim should be intact.

The articular cartilage should be conserved or present maximum third-degree lesion according to ICRS classification. However, concomitant treatment of more complex focal cartilage lesions with microfracture, osteochondral scaffold implantation, and chondroabrasion has been reported [15, 16].

The patients must be relatively young and willing to follow the rehab protocol. The knee must be stable and aligned or a ligament reconstruction and/or an osteotomy must be performed.

The contraindications are skeletally immature subjects, previous total meniscectomy, meniscal roots lesions, severe osteoarthritis, allergy to the material of the implant, elderly patients, infection, or inflammatory diseases.

Surgical technique: The first steps are to check arthroscopically the correct indication for the implant and to remove all pathological tissues. Then, a bed is prepared for the CMI and bleeding is obtained from the parameniscal tissues in order to support the meniscal ingrowths. Then, the meniscus defect is measured and the implant is cut 10% longer than the measured area. The completely dry implant is delivered into the joint using a clamp for vascular surgery. The suture is started with an all inside technique and in most cases the suture is completed with the same technique, although in some cases, if necessary, the suture can be completed with an in-out technique. Generally, the stitches are put vertically into the central part of the implant and horizontally at the extremities.

Rehabilitation protocol: During the first weeks after surgery, the patient must wear a knee brace with a progressive range of motion. Complete movement is allowed after 6 weeks. The weight-bearing program is also progressive: in the first weeks, it is partial and becomes complete after 10 weeks. Immediate isometric muscle strengthening exercises are recommended and free activities are not allowed for 6 months.


30.2 Medium- and Long-Term Outcomes



30.2.1 Clinical Results


CMI: It has been used in clinical practice for over 15 years and some studies regarding the long-term results have been published.

In a paper by Zaffagnini et al. [17], the outcomes of 33 patients with meniscal lesions treated by medial CMI implant or partial meniscectomy with a 10-year minimum follow-up are reported. Ten years after surgery in the CMI group all examined clinical parameters had improved significantly with respect to preoperative status. The patients who received the CMI compared with those treated with meniscectomy only showed significantly lower VAS score and higher objective IKDC, Tegner index and SF-36.

Monllau et al. [18] also reported the results of 22 patients treated with medial CMI implant at a10-year minimum follow-up. At the final follow-up, no patient complained of meniscal symptoms or complications related to the implant.

Lysholm and VAS scores improved significantly at 1 year and remained unchanged at final follow-up 10 years after surgery.

Also in our experience [19], 26 CMI patients who were clinically evaluated showed a significant improvement of Lysholm and Tegner activity score 2 years after the implantation, and the results essentially did not change up to a 10-year follow-up.

In another study [20], a group of 17 patients treated with ACL reconstruction plus medial CMI was compared to a similar group of 17 patients who were treated with ACL reconstruction plus meniscectomy at 9.6 years follow-up on average. An improvement of clinical parameters and knee stability was observed in both groups. In the CMI group, the VAS was lower and the joint stability better with respect to those meniscectomized.

The lateral CMI has been in clinical use since 2006. In literature, two studies [21, 22] report the results with a 2-year minimum follow-up. In both studies, the clinical outcomes are similar to those of the medial CMI. All the scores improved significantly with respect to preoperative status. The activity level is similar to that of pre-injury in over half the cases and most of the patients were satisfied.

Actifit has been available for less time, and recently some studies at medium-term follow-up have been published.

In a study by Schuttler et al. [23], 16 patients treated with Actifit implantations were evaluated up to 48 months follow-up. Complications were not observed. All the clinical scores used (KOOS, KSS, VAS) improved progressively and significantly with respect to the preoperative ones.

The UCLA activity score increased up to 2 years, but it worsened at 4 years after surgery.

Dhollander et al. [24] reported the results of 44 patients with irreparable, partial meniscal defect (29 medial and 15 lateral) implanted with a polyurethane scaffold in a prospective study with a minimum 5-year follow-up. The outcomes were evaluated with VAS, IKDC, and KOOS scores. Knee function and pain improved significantly up to 5 years after implantation.

Filardo et al. [15] also observed a significant improvement in the clinical parameters considered (IKDC and Tegner score) of 16 patients evaluated pre-op, 24, 36, 48, 60, and 72 months postoperatively. The improvement was significant at 2 years and remained unchanged on the following follow-up visit. However, the activity level remained lower than that of pre-lesion.


30.2.2 Radiographic Results


Zaffagnini et al. [17] in the comparative study of medial CMI and partial medial meniscectomy results at long-term follow-up, also evaluated the radiographic outcomes with bilateral weight-bearing long-standing x-ray. A significantly less medial joint space narrowing in the CMI group than that of meniscectomy was observed.

Mollau et al. [18] also studied with long-standing x-ray and Rosenberg view the patients treated with medial CMI at 10 years follow-up. All the subjects were evaluated with the Ahlback scale, only 4 patients out of 22 showed a progression of osteoarthritis, from preoperative Grade 0 to Grade 1 at final follow-up.

In our study [20] comparing patients operated on with ACL reconstruction associated with CMI or meniscectomy at 9.6 average follow-up, no significant radiographic changes between healthy and operated knees were observed in either group.

In the studies of Actifit implant at medium-term follow-up, no radiographic evaluations are reported.


30.2.3 MRI Results


In most of the studies, morphology and intensity of the implant MRI signal, and the status of joint cartilage were evaluated with Genovese [25] and Yulish [26] scores, respectively, for both implants (Tables 30.1 and 30.2).


Table 30.1
Genovese score for morphology and intensity MRI signal after scaffold implantation [25]
























Characteristic

Type 1

Type 2

Type 3

Morphology and size

Totally reabsorbed implant

Small implant with regular and/or irregular morphology

Implant with identical shape and size to the normal meniscus

Signal intensity

Hyperintense

Slightly hyperintense

Isointense relative to the normal meniscus (no signal)



Table 30.2
Yulish score for MRI evaluation joint cartilage [26]






















Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Normal

Normal contour ± abnormal signal

Superficial fraying; erosion or ulceration of less than 50%

Partial-thickness defect of more than 50%but less than 100%

Full-thickness cartilage loss

CMI: In all the MRI evaluations of patients who received a CMI with a minimum 10 years follow-up, a progressive worsening of the Genovese score on the signal morphology of the implant was observed. The signal was reduced in size and irregular and sometimes completely absorbed. (Genovese Grade 2 and 1). On the contrary, the markedly hyperintense signal observed after the implantation became less intense over time, but only in a limited number of cases was it similar to a normal meniscus. (Genovese Grade 3). In all cases, the interface between the new tissue and the native meniscal tissue could no longer be resolved [18].

In a review by Zaffagnini et al. [27] regarding the evolution of the CMI MRI signal, a progressive worsening of the implant morphology which appeared reduced in size or absorbed and the progressive decrease of the hyperintensity of the signal were confirmed. This behavior could be due to the reabsorption of the scaffold over time or to its collapse due to the loading stresses, while the reduced hyperintensity could depend on the ingrowth of new tissue.

In another study by Zaffagnini et al. [17], the aspect of articular cartilage, evaluated with Yulish score, was better in the patients treated with CMI with respect to those who had a partial meniscectomy; however, these differences were not significant.

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Jul 31, 2017 | Posted by in ORTHOPEDIC | Comments Off on Clinical Use of the Meniscal Scaffold

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