Outcome After Partial Medial Meniscus Substitution With the Collagen Meniscal Implant at a Minimum of 10 Years' Follow-up

doi:10.1016/j.arthro.2011.02.018

Arthroscopy: The Journal of Arthroscopic & Related Surgery

Volume 27, Issue 7, July 2011, Pages 933-943

https://doi.org/10.1016/j.arthro.2011.02.018 Get rights and content

Purpose

The aim of the study was to evaluate the clinical outcome of a collagen meniscus graft implanted in an injured medial meniscus after a minimum of 10 years' follow-up.

Methods

Twenty-five patients underwent arthroscopic implantation of the collagen meniscus device. They had either persistent compartmental joint line pain due to a previous medial meniscus resection (5 cases) or a large irreparable meniscus tear at arthroscopy (20 cases). Implant failure was defined as infection due to the implant or mechanical failure of the device. Twenty-two patients returned for clinical, functional, and radiographic evaluation. Magnetic resonance imaging was also performed and was analyzed with the criteria of Genovese et al. (where type 3 indicates normal and type 1 indicates completely abnormal). All the aforementioned evaluations were carried out at a minimum of 10 years (range, 10.1 to 12.5 years) after the procedure.

Results

The mean Lysholm score improved from 59.9 preoperatively to 89.6 at 1 year (P < .001), and it was 87.5 at final follow-up (P < .001). The results were good or excellent in 83% of the population. No differences were observed when we compared the Lysholm score at 1 year of follow-up with the score at final follow-up (P > .05). The mean pain score on a visual analog scale improved by 3.5 points at final follow-up. Patient satisfaction with the procedure was 3.4 of 4 points. Radiographic evaluation showed either minimal or no narrowing of the joint line. Magnetic resonance imaging showed type 2 in 64% of cases and type 3 in 21%. All cases showed less volume than expected (size type 2 in 89%). The failure rate in the patient population was 8% (2 of 25). There were no complications related to the device.

Conclusions

Although there were several different types of patients and acute and chronic tears were treated in a limited number of patients, meniscal substitution with the collagen meniscal implant provides significant pain relief and functional improvement after a minimum of 10 years' follow-up. The implant generally diminished in size, but the procedure proved to be safe and had a low rate of implant failure on a long-term basis. No development or progression of degenerative knee joint disease was observed in most cases.

Level of Evidence

Level IV, therapeutic case series.

Section snippets

Methods

Between September 1997 and January 2000, a total of 25 patients underwent CMI implantation. All the patients were included in the European Multicenter Prospective Study. The procedure was performed in patients with either persistent medial compartmental joint line pain due to a previous sizable meniscus resection or a large irreparable meniscus tear at arthroscopy. The presence of anterior and posterior meniscus remnants as well as an intact outer rim of the meniscus was a necessary condition

Results

The 22 patients who returned for final follow-up evaluation had a mean age of 42.3 years (range, 23.1 to 58.2 years). At the time of final follow-up, no patient was observed to have any meniscal symptoms. No complications related to the implant were reported in these 22 patients either.

Discussion

This study evaluated the functional and radiographic results of CMI implantation with a minimum of 10 years of follow-up after surgery and showed the effectiveness of the procedure. This technique improved knee function and symptoms in this group of patients. The Lysholm and VAS pain scores significantly improved for at least 10 years when compared with preoperative values. This confirms our first hypothesis. The procedure also was safe, because no complications were noted as a result of the

Conclusions

Although there were several different types of patients and acute and chronic tears were treated in a limited number of patients, meniscal substitution with the CMI provides significant pain relief and functional improvement after a minimum of 10 years' follow-up. The implant generally diminished in size, but the procedure proved to be safe and had a low rate of implant failure on a long-term basis. No development or progression of degenerative knee joint disease was observed in most cases.

Acknowledgment

We are grateful to Eric Goode for his help in correcting the manuscript.

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Cited by (133)

Loss of chondroprotection of medial collagen meniscus implant (CMI) at 20-year follow-up
2024, Journal of ISAKOS
The mid-term results of the collagen meniscus implant (CMI) procedure for the replacement of partial meniscus defects have already been described. However, there is a paucity of long-term comparative studies. This study aimed to compare the clinical outcomes, failures, and osteoarthritis progression of patients who underwent partial medial meniscectomy and medial CMI implantation.
Thirty-six nonconsecutive patients with medial meniscus injuries that underwent medial CMI (MCMI) implantation or partial medial meniscectomy (PMM) between 1997 and 2000 were included in a prospective study with an intermediate 10-year follow-up examination and a final follow-up examination at 20-year follow-up. Outcome measures at the 20-year follow-up included the Lysholm score, visual analogue scale (VAS) for pain, International Knee Documentation Committee (IKDC) knee form , and Tegner activity level. Bilateral weight-bearing radiographs were also performed to evaluate hip-knee-angle (HKA) and the medial joint line height (JL). Data regarding complications and failures were also collected.
At the 20-year follow-up, 31 patients (83% follow-up rate) with a mean age of 60.7 ± 8.9 years were included in the final analysis (21.1 ± 1.2 years follow-up). Four reoperations and one failure per group were reported. When comparing the clinical results of the two groups, no difference was found considering the Lysholm score, Knee Injury and Osteoarthritis Outcome Score (KOOS), Tegner, and the IKDC. Moreover, 20 patients underwent radiographic examination (10 MCMI, 10 MM), and no statistically significant difference was reported concerning the JL, HKA, and the presence and incidence of osteoarthritis between the two groups.
The CMI implant for partial medial meniscectomy provided good long-term results and a low failure rate. However, differently from the 10 years follow-up, the clinical and the radiological outcomes were not superior compared to the medial meniscectomy group. The present study's result suggests that using a medial scaffold is not chondroprotective.
III, Prospective case–control study.
Clinical Outcomes After Polyurethane Meniscal Scaffolds Implantation Remain Stable Despite a Joint Space Narrowing at 10-Year Follow-Up
2024, Arthroscopy - Journal of Arthroscopic and Related Surgery
To report the clinical outcomes, radiologic evolution, and survivorship of a series of patients affected by the postmeniscectomy syndrome and treated with a polyurethane scaffold at a minimum 10-year follow-up. In addition, the radiologic evolution of these patients was also assessed.
All the patients operated on with a polyurethane meniscal scaffold implantation to treat postmeniscectomy syndrome from 2008 to 2011 were prospectively followed. Clinical evaluations and radiologic studies were assessed at the preoperative period, at 5-year follow-up, and at minimum 10-year follow-up. Clinical outcomes were based on patient-reported outcomes (e.g., the Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee, Lysholm, and Tegner). Radiographical evaluation of the joint-space narrowing was done in the Rosenberg view. Failure was defined as patients who required surgery to remove the scaffold or those patients who needed surgery for a total or partial knee replacement.
Twenty-one of 27 patients, with a mean age of 56 ± 9.8 years, were available for the final follow-up. The mean follow-up was 11.8 (range, 10-12.7) years. Six patients were lost to follow-up. All functional scores showed a significant improvement (P < .001) at the 5- and 10-year follow-up. The exception was the Tegner score, which remained stable. The joint-space width was maintained from the preoperative period (1.9 ± 1.2 mm) up to the 5-year follow-up (1.3 ± 1.5 mm, P = .3) and decreased by the last evaluation (0.6 ± 1.2 mm, P = .001) at the last follow-up. Two (9.5%) of 21 patients were converted to a total knee replacement during the study period. None of the other patients needed revision surgery during the study period.
The polyurethane meniscal scaffold provides significant and stable pain relief over time and improved functional outcomes at a minimum of 10 years after surgery. However, degenerative changes progressed in the treated compartment, with a joint-space narrowing over the 10-year period.
Level IV, retrospective case series.
Short-Term but Not Long-Term Knee Symptoms and Functional Improvements of Tissue Engineering Strategy for Meniscus Defects: A Systematic Review of Clinical Studies
2024, Arthroscopy - Journal of Arthroscopic and Related Surgery
To investigate the up-to-date clinical outcomes of tissue-engineered meniscus implants for meniscus defects.
A search was performed by 3 independent reviewers on PubMed, MEDLINE, EMBASE, and Cochrane from 2016 to June 18, 2023, with the term “meniscus” with all the following terms: “scaffolds,” “constructs,” “implant,” and “tissue engineering.” Inclusion criteria included “Clinical trials” and “English language articles” that involved isolated meniscus tissue engineering strategies for meniscus injuries. Only Level I to IV clinical studies were considered. The modified Coleman Methodology score was used for quality analysis of included clinical trials. The Methodological Index for Non-Randomized Studies was employed for analysis of the risk of study bias and methodological quality.
The search identified 2,280 articles, and finally 19 original clinical trials meeting the inclusion criteria were included. Three types of tissue-engineered meniscus implants (CMI-Menaflex, Actifit, and NUsurface) have been clinically evaluated for meniscus reconstruction. Lack of standardized outcome measures and imaging protocols limits comparison between studies.
Tissue-engineered meniscus implants can provide short-term knee symptom and function improvements, but no implants have been shown to propose significant long-term benefits for meniscus defects.
Level IV, systematic review of Level I to IV studies.
Bioactive and Bioinductive Implants Are Increasingly Used in Orthopaedic Sports Medicine but Adequately Controlled Studies Are Needed: A Scoping Review
2024, Arthroscopy - Journal of Arthroscopic and Related Surgery
To describe the currently available literature reporting clinical outcomes for bioactive and bioinductive implants in sports medicine.
In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic search of 4 databases was completed to identify eligible studies. Inclusion criteria were studies using bioactive or bioinductive implants in human clinical studies for sports medicine procedures. Data were extracted and reported in narrative form, along with study characteristics.
In total, 145 studies were included involving 6,043 patients. The majority of included studies were level IV evidence (65.5%), and only 36 included a control group (24.8%). Bioactive materials are defined as any materials that stimulate an advantageous response from the body upon implantation, whereas bioinductive materials provide a favorable environment for a biological response initiated by the host. Bioactivity can speed healing and improve clinical outcome by improving vascularization, osteointegration, osteoinduction, tendon healing, and soft-tissue regeneration or inducing immunosuppression or preventing infection. The most common implants reported were for knee (67.6%, primarily cartilage [most commonly osteochondral defects], anterior cruciate ligament, and meniscus), shoulder (16.6%, primarily rotator cuff), or ankle (11.7%, primarily Achilles repair). The most common type of implant was synthetic (44.1%), followed by autograft (30.3%), xenograft (16.6%), and allograft (9.0%). In total, 69% of implants were standalone treatments and 31% were augmentation.
The existing bioactive and bioinductive implant literature in sports medicine is largely composed of small, low-level-of-evidence studies lacking a control group.
Before bioactive implants can be adapted as a new standard of care, larger, comparative clinical outcome studies with long-term follow-up are essential.
3D printing of mechanically functional meniscal tissue equivalents using high concentration extracellular matrix inks
2023, Materials Today Bio
Decellularized extracellular matrix (dECM) has emerged as a promising biomaterial in the fields of tissue engineering and regenerative medicine due to its ability to provide specific biochemical and biophysical cues supportive of the regeneration of diverse tissue types. Such biomaterials have also been used to produce tissue-specific inks and bioinks for 3D printing applications. However, a major limitation associated with the use of such dECM materials is their poor mechanical properties, which limits their use in load-bearing applications such as meniscus regeneration. In this study, native porcine menisci were solubilized and decellularized using different methods to produce highly concentrated dECM inks of differing biochemical content and printability. All dECM inks displayed shear thinning and thixotropic properties, with increased viscosity and improved printability observed at higher pH levels, enabling the 3D printing of anatomically defined meniscal implants. With additional crosslinking of the dECM inks following thermal gelation at pH 11, it was possible to fabricate highly elastic meniscal tissue equivalents with compressive mechanical properties similar to the native tissue. These improved mechanical properties at higher pH correlated with the development of a denser network of smaller diameter collagen fibers. These constructs also displayed repeatable loading and unloading curves when subjected to long-term cyclic compression tests. Moreover, the printing of dECM inks at the appropriate pH promoted a preferential alignment of the collagen fibers. Altogether, these findings demonstrate the potential of 3D printing of highly concentrated meniscus dECM inks to produce mechanically functional and biocompatible implants for meniscal tissue regeneration. This approach could be applied to a wide variety of different biological tissues, enabling the 3D printing of tissue mimics with diverse applications from tissue engineering to surgical planning.
Meniscal restoration: scaffolds, transplantation, and implants
2023, Journal of Cartilage and Joint Preservation
Preservation of the injured meniscus tissue is the ideal goal of surgical treatment. However, many meniscal tears are not repairable with the result a loss of varying degrees of meniscal tissue. Various techniques are available to replace either portions of lost meniscal tissue or the entire meniscus. These techniques include the use of scaffolds, meniscal allografts, and synthetic meniscal implants. This article reviews the techniques utilized to restore the deficient meniscus.

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: The authors report no conflict of interest.

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Original ArticleOutcome After Partial Medial Meniscus Substitution With the Collagen Meniscal Implant at a Minimum of 10 Years' Follow-up

Purpose

Methods

Results

Conclusions

Level of Evidence

Section snippets

Methods

Results

Discussion

Conclusions

Acknowledgment

Arthroscopy

Knee

Arthroscopy

Tibial meniscal dynamics using three-dimensional reconstruction of magnetic resonance images

Am J Sports Med

Tibiofemoral contact mechanics after serial medial meniscectomies in the human cadaveric knee

Am J Sports Med

Load bearing mode of the knee joint: Physical behavior of the knee joint with and without menisci

Clin Orthop Relat Res

The role of meniscal root pathology and radial meniscal tear in medial meniscal extrusion

Skeletal Radiol

Knee joint changes after meniscectomy

J Bone Joint Surg Br

Future directionsCollagen-based prostheses for meniscal regeneration

Clin Orthop Relat Res

Regeneration of meniscal cartilage with use of a collagen scaffoldAnalysis of preliminary data

J Bone Joint Surg Am

Histology and ultrastructure of a tissue-engineered collagen meniscus before and after implantation

J Biomed Mater Res B Appl Biomater

Follow-up of collagen meniscus implants by MRI

Radiol Med

Comparison of the collagen meniscus implant with partial meniscectomyA prospective randomized trial

J Bone Joint Surg Am

Original Article
Outcome After Partial Medial Meniscus Substitution With the Collagen Meniscal Implant at a Minimum of 10 Years' Follow-up