Luca De Marziani, Angelo Boffa, Luca Andriolo, Alessandro Di Martino, Iacopo Romandini, Luca Solaro, Stefano Zaffagnini, Giuseppe Filardo
{"title":"用于治疗膝关节表面损伤的无细胞仿生骨软骨支架：临床效果因患者和病变特征而异","authors":"Luca De Marziani, Angelo Boffa, Luca Andriolo, Alessandro Di Martino, Iacopo Romandini, Luca Solaro, Stefano Zaffagnini, Giuseppe Filardo","doi":"10.1002/ksa.12402","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>A cell-free biomimetic osteochondral scaffold was developed to treat cartilage knee lesions, with positive clinical results documented in small case series. However, clear evidence on patient and lesion characteristics that might affect the outcome is still lacking. The aim of this study is to analyse a large cohort of patients treated with this scaffold to investigate factors that could influence the clinical outcome.</p><p><strong>Methods: </strong>Two hundred and three patients (mean age 30.7 ± 10.9 years) treated with this scaffold were prospectively evaluated at baseline, 6-, 12- and 24-month follow-up. The clinical outcome was analysed using the International Knee Documentation Committee (IKDC) score, and the activity level was assessed with the Tegner score. The influence of patient and lesion characteristics on clinical outcomes was analysed.</p><p><strong>Results: </strong>Mild and severe adverse reactions were found in 39.0% and 1.5% of patients, respectively. The failure rate was 2.0%, increasing to 12.3% when including also clinical failures. The IKDC subjective score increased from 43.3 ± 15.9 to 61.0 ± 16.2 at 6 months, 68.3 ± 18.5 at 12 months and 73.8 ± 18.3 at 24 months (p < 0.0005). The Tegner improved from 2.5 ± 1.7 to 4.2 ± 1.7 at 24 months (p < 0.0005), without reaching the pre-injury level (6.0 ± 2.2) (p < 0.0005). The IKDC objective score changed from 68.5% normal and nearly normal knees before the treatment to 90.1% at 24 months. At 24 months, age showed a correlation with the IKDC subjective score (ρ = -0.247; p < 0.0005), women had a lower score (p < 0.0005), as well as patients with patellar lesions (p = 0.002). Previous surgery correlated with lower results (p = 0.003), while better results were found in osteochondritis dissecans (OCD) compared to degenerative lesions (p = 0.001).</p><p><strong>Conclusion: </strong>This cell-free biomimetic scaffold is a safe and effective treatment for cartilage knee lesions, offering positive clinical results at 2 years with a low failure rate. Better outcomes were observed in younger patients, in lesions of the femoral condyles and in OCD, while joints affected by patellar lesions, patients who underwent previous knee surgery, and women may expect lower results.</p><p><strong>Level of evidence: </strong>III, Cohort study.</p>","PeriodicalId":17880,"journal":{"name":"Knee Surgery, Sports Traumatology, Arthroscopy","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cell-free biomimetic osteochondral scaffold for the treatment of knee articular surface lesions: Clinical outcomes differ based on patient and lesion characteristics.\",\"authors\":\"Luca De Marziani, Angelo Boffa, Luca Andriolo, Alessandro Di Martino, Iacopo Romandini, Luca Solaro, Stefano Zaffagnini, Giuseppe Filardo\",\"doi\":\"10.1002/ksa.12402\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>A cell-free biomimetic osteochondral scaffold was developed to treat cartilage knee lesions, with positive clinical results documented in small case series. However, clear evidence on patient and lesion characteristics that might affect the outcome is still lacking. The aim of this study is to analyse a large cohort of patients treated with this scaffold to investigate factors that could influence the clinical outcome.</p><p><strong>Methods: </strong>Two hundred and three patients (mean age 30.7 ± 10.9 years) treated with this scaffold were prospectively evaluated at baseline, 6-, 12- and 24-month follow-up. The clinical outcome was analysed using the International Knee Documentation Committee (IKDC) score, and the activity level was assessed with the Tegner score. The influence of patient and lesion characteristics on clinical outcomes was analysed.</p><p><strong>Results: </strong>Mild and severe adverse reactions were found in 39.0% and 1.5% of patients, respectively. The failure rate was 2.0%, increasing to 12.3% when including also clinical failures. The IKDC subjective score increased from 43.3 ± 15.9 to 61.0 ± 16.2 at 6 months, 68.3 ± 18.5 at 12 months and 73.8 ± 18.3 at 24 months (p < 0.0005). The Tegner improved from 2.5 ± 1.7 to 4.2 ± 1.7 at 24 months (p < 0.0005), without reaching the pre-injury level (6.0 ± 2.2) (p < 0.0005). The IKDC objective score changed from 68.5% normal and nearly normal knees before the treatment to 90.1% at 24 months. At 24 months, age showed a correlation with the IKDC subjective score (ρ = -0.247; p < 0.0005), women had a lower score (p < 0.0005), as well as patients with patellar lesions (p = 0.002). Previous surgery correlated with lower results (p = 0.003), while better results were found in osteochondritis dissecans (OCD) compared to degenerative lesions (p = 0.001).</p><p><strong>Conclusion: </strong>This cell-free biomimetic scaffold is a safe and effective treatment for cartilage knee lesions, offering positive clinical results at 2 years with a low failure rate. Better outcomes were observed in younger patients, in lesions of the femoral condyles and in OCD, while joints affected by patellar lesions, patients who underwent previous knee surgery, and women may expect lower results.</p><p><strong>Level of evidence: </strong>III, Cohort study.</p>\",\"PeriodicalId\":17880,\"journal\":{\"name\":\"Knee Surgery, Sports Traumatology, Arthroscopy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2024-08-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Knee Surgery, Sports Traumatology, Arthroscopy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ksa.12402\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ORTHOPEDICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Knee Surgery, Sports Traumatology, Arthroscopy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ksa.12402","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
Cell-free biomimetic osteochondral scaffold for the treatment of knee articular surface lesions: Clinical outcomes differ based on patient and lesion characteristics.
Purpose: A cell-free biomimetic osteochondral scaffold was developed to treat cartilage knee lesions, with positive clinical results documented in small case series. However, clear evidence on patient and lesion characteristics that might affect the outcome is still lacking. The aim of this study is to analyse a large cohort of patients treated with this scaffold to investigate factors that could influence the clinical outcome.
Methods: Two hundred and three patients (mean age 30.7 ± 10.9 years) treated with this scaffold were prospectively evaluated at baseline, 6-, 12- and 24-month follow-up. The clinical outcome was analysed using the International Knee Documentation Committee (IKDC) score, and the activity level was assessed with the Tegner score. The influence of patient and lesion characteristics on clinical outcomes was analysed.
Results: Mild and severe adverse reactions were found in 39.0% and 1.5% of patients, respectively. The failure rate was 2.0%, increasing to 12.3% when including also clinical failures. The IKDC subjective score increased from 43.3 ± 15.9 to 61.0 ± 16.2 at 6 months, 68.3 ± 18.5 at 12 months and 73.8 ± 18.3 at 24 months (p < 0.0005). The Tegner improved from 2.5 ± 1.7 to 4.2 ± 1.7 at 24 months (p < 0.0005), without reaching the pre-injury level (6.0 ± 2.2) (p < 0.0005). The IKDC objective score changed from 68.5% normal and nearly normal knees before the treatment to 90.1% at 24 months. At 24 months, age showed a correlation with the IKDC subjective score (ρ = -0.247; p < 0.0005), women had a lower score (p < 0.0005), as well as patients with patellar lesions (p = 0.002). Previous surgery correlated with lower results (p = 0.003), while better results were found in osteochondritis dissecans (OCD) compared to degenerative lesions (p = 0.001).
Conclusion: This cell-free biomimetic scaffold is a safe and effective treatment for cartilage knee lesions, offering positive clinical results at 2 years with a low failure rate. Better outcomes were observed in younger patients, in lesions of the femoral condyles and in OCD, while joints affected by patellar lesions, patients who underwent previous knee surgery, and women may expect lower results.
期刊介绍：
Few other areas of orthopedic surgery and traumatology have undergone such a dramatic evolution in the last 10 years as knee surgery, arthroscopy and sports traumatology. Ranked among the top 33% of journals in both Orthopedics and Sports Sciences, the goal of this European journal is to publish papers about innovative knee surgery, sports trauma surgery and arthroscopy. Each issue features a series of peer-reviewed articles that deal with diagnosis and management and with basic research. Each issue also contains at least one review article about an important clinical problem. Case presentations or short notes about technical innovations are also accepted for publication.
The articles cover all aspects of knee surgery and all types of sports trauma; in addition, epidemiology, diagnosis, treatment and prevention, and all types of arthroscopy (not only the knee but also the shoulder, elbow, wrist, hip, ankle, etc.) are addressed. Articles on new diagnostic techniques such as MRI and ultrasound and high-quality articles about the biomechanics of joints, muscles and tendons are included. Although this is largely a clinical journal, it is also open to basic research with clinical relevance.
Because the journal is supported by a distinguished European Editorial Board, assisted by an international Advisory Board, you can be assured that the journal maintains the highest standards.
Official Clinical Journal of the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).
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