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Table 2 List of inclusion and exclusion criteria for patients by study

From: Failure rates and clinical outcomes of synthetic meniscal implants following partial meniscectomy: a systematic review

 

Paper

Inclusion and exclusion criteria

Actifit

Leroy et al. [14]

Inclusion patients between 18 and 50 years of age with stable or stabilised knee with post-meniscectomy pain. Prior meniscectomy had to be partial with an intact meniscal rim and anterior and posterior horns on pre-operative MRI

Exclusion patients with an alignment defect on standing long-leg radiographs of more than 5° or ICRS 3 and 4 chondral lesions in mirror or extended more than 2 cm2

 

Dhollander et al. [15]

Inclusion an irreparable medial or lateral meniscal tear or partial meniscus loss with an intact rim, skeletally mature male or female patients, from 16 to 50 years of age, a stable knee joint or knee joint stabilisation procedure within 12 weeks of the index procedure, International Cartilage Repair Society (ICRS) classification < 3, no more than three surgeries on the involved meniscus

Exclusion total meniscus loss or an unstable segmental rim defect, a meniscal root tear, multiple areas of unilateral partial meniscus loss that could not be treated by a single scaffold, ICRS classification > 3, BMI > 35 kg/m2 and untreated tibiofemoral malalignment

 

Toanen et al. [16]

Inclusion an irreparable medial or lateral meniscal tear or partial meniscus loss with an intact rim, skeletally mature male or female patients, from 16 to 50 years of age, a stable knee joint or knee joint stabilisation procedure within 12 weeks of the index procedure, International Cartilage Repair Society (ICRS) classification < 3, no more than three surgeries on the involved meniscus

Exclusion total meniscus loss or an unstable segmental rim defect, a meniscal root tear, multiple areas of unilateral partial meniscus loss that could not be treated by a single scaffold, ICRS classification > 3, BMI > 35 kg/m2 and untreated tibiofemoral malalignment

 

Monllau et al. [17]

Inclusion persistent medial or lateral joint line due to a previous partial meniscus resection, intact outer rim of the meniscus

Exclusion complete loss of the corresponding meniscus, symptomatic grade III or IV chondral injury in whatever knee compartment, untreated instability, untreated varus or valgus malalignment greater than 5°, inflammatory arthritis, polyurethane allergies, autoimmune disease and pregnancy were excluded

 

Filardo et al. [18]

Inclusion skeletally mature patients, affected by meniscal loss greater than 25%, intact anterior and posterior meniscus attachments, intact rim at the circumference of the missing meniscus

Exclusion patients with uncorrected knee axis deviation or instability, allergy to polyurethane, systemic administration of corticosteroids/immunosuppressive agents within 30 days before surgery, osteonecrosis of the index knee, history of infectious, neoplastic, metabolic or inflammatory conditions

CMI

  
 

Zaffagnini et al. [19]

Inclusion irreparable acute meniscal tears requiring partial meniscectomy or chronic prior loss of meniscal tissue (traumatic or degenerative) greater than 25%, intact anterior and posterior attachments of the meniscus, intact rim (1 mm or greater) over the entire circumference of the involved meniscus, anterior cruciate ligament (ACL) deficiencies stabilised at the time of the index surgery, participant between 15 and 60 years of age, contralateral healthy knee

Exclusion concomitant posterior cruciate ligament (PCL) insufficiency of the involved knee, diagnosis of Outerbridge grade IV, uncorrected malformations or axial malalignment, documented allergy to collagen or chondroitin sulfate of animal origin, systemic or local infection, history of anaphylactoid reaction, systemic administration of any type of corticosteroid or immunosuppressive agents within 30 days of surgery, evidence of osteonecrosis in the involved knee, history of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases, neurological abnormalities or conditions that would preclude the patient’s requirements for the rehabilitation program, pregnancy

 

Steadman et al. [20]

Inclusion acute or chronic injuries resulting in loss of at least one-third of the native meniscus but who had an intact meniscus rim of at least 1 mm or greater, stable or stabilised knee at the time of surgery

Exclusion total meniscus loss, grade IV (full thickness) chondral defects, varus axial malalignment, inflammatory or systemic disease, had known collagen allergies, were diagnosed with autoimmune disease or were pregnant

 

Zaffagnini et al. [21]

Inclusion irreparable medial meniscus tear at arthroscopy or a previous major loss of meniscus cartilage after partial meniscectomy. Knees had to be stable or surgically stabilised at the time of the implantation procedure. Both traumatic and degenerative loss of meniscus cartilage were included

 

Bulgheroni et al. [22]

Inclusion combined ACL and CMI implantation from 2001 to 2005 in two hospitals and all patients included in this study had acute or chronic complete ACL rupture associated with irreparable medial meniscus injury requiring partial meniscectomy or with partial defect from previous partial meniscectomy

 

Bulgheroni et al. [23]

Inclusion irreparable medial meniscus tears with meniscus removal greater than 25% of total meniscus or presence of persistent pain after meniscectomy, according to the instructions for use of the CMI provided by the producer

Exclusion patients with Outerbridge grade IV chondral lesions, autoimmune diseases, infection, other systemic diseases, collagen of animal origin allergies and aged over 60 years

 

Monllau et al. [24]

Inclusion persistent medial compartmental joint line pain associated with sizeable meniscus resection or irreparable meniscus tear at arthroscopy. Anterior and posterior meniscus remnants and intact outer meniscal rims were necessary conditions for the procedure. Anterior cruciate ligament (ACL) deficiency was not considered a contraindication if the ligament was reconstructed at the same time as the CMI implantation

Exclusion Ahlbäck grade > II on the radiographs of the medial tibiofemoral compartment, complete loss of the medial meniscus, lateral meniscus injuries, untreated instability, grade IV chondral lesions, axial deviation greater than 5°, inflammatory arthritis, collagen allergies, autoimmune disease and pregnancy

NUsurface

McKeon et al. [11]

Inclusion Previous medial meniscectomy confirmed by MRI and history at least 6 months before the start of study treatment, pain score ≤ 75 on the Knee Injury and Osteoarthritis Outcome Score, ≥ 2 mm intact meniscal rim, age between 30 and 75 years, neutral alignment ±5° of the mechanical axis

Exclusion Outerbridge grade IV, varus/valgus knee deformity > 5°, knee laxity, level > II ICRS, secondary to previous injury any knee ligament, patellar compartment pain and/or patellar articular cartilage damage, ACL reconstruction performed < 9 months before implantation and body mass index > 32.5