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Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes

Peter Verdonk UGent, Philippe Beaufils, Johan Bellemans, Patrick Djian, Eva-Lisa Heinrichs, Wouter Huysse UGent, Heinz Laprell, Rainer Siebold and René Verdonk UGent (2012) AMERICAN JOURNAL OF SPORTS MEDICINE. 40(4). p.844-853
abstract
Background: A novel, biodegradable, polyurethane scaffold was designed to fulfill an unmet clinical need in the treatment of patients with painful irreparable partial meniscal defects. Hypothesis: The use of an acellular polyurethane scaffold for new tissue generation in irreparable partial meniscal defects provides both pain relief and improved functionality. Study Design: Case series; Level of evidence, 4. Methods: Fifty-two patients with irreparable partial meniscal defects (34 medial and 18 lateral, 88% with 1-3 previous surgeries on the index meniscus) were implanted with a polyurethane scaffold in a prospective, single-arm, multicenter, proof-of-principle study. Safety was assessed by the rate of scaffold-related serious adverse events (SAEs) and the International Cartilage Repair Society articular cartilage scoring system comparing magnetic resonance imaging (MRI) at 24 months to MRI at baseline (1 week). Kaplan-Meier time to treatment failure distributions were performed. Clinical outcomes were measured comparing visual analog scale, International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Lysholm scores at 24 months from baseline (entry into study). Results: Clinically and statistically significant improvements (P < .0001) compared with baseline were reported in all clinical outcome scores (baseline/24 months): visual analog scale (45.7/20.3), International Knee Documentation Committee (45.4/70.1), KOOS symptoms (64.6/78.3), KOOS pain (57.5/78.6), KOOS activities of daily living (68.8/84.2), KOOS sports (30.5/59.0), KOOS quality of life (33.9/56.6), and Lysholm (60.1/80.7), demonstrating improvements in both pain and function. The incidence of treatment failure was 9 (17.3%) patients, of which 3 patients (8.8%) had medial meniscal defects and 6 patients (33.3%) had lateral meniscal defects. There were 9 SAEs requiring reoperation. Stable or improved International Cartilage Repair Society cartilage grades were observed in 92.5% of patients between baseline and 24 months. Conclusion: At 2 years after implantation, safety and clinical outcome data from this study support the use of the polyurethane scaffold for the treatment of irreparable, painful, partial meniscal defects.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
polyurethane scaffold, meniscectomy, biodegradable scaffold, meniscus, Actifit, partial meniscectomy, meniscal defect, irreparable meniscal defect, ARTHROSCOPIC PARTIAL MENISCECTOMY, PARTIAL LATERAL MENISCECTOMY, OTHERWISE NORMAL KNEE, TERM FOLLOW-UP, RELIABILITY, SCORE, SCALE, RESPONSIVENESS, REPAIR, LYSHOLM KNEE
journal title
AMERICAN JOURNAL OF SPORTS MEDICINE
Am. J. Sports Med.
volume
40
issue
4
pages
844 - 853
Web of Science type
Article
Web of Science id
000302285100015
JCR category
ORTHOPEDICS
JCR impact factor
4.439 (2012)
JCR rank
1/63 (2012)
JCR quartile
1 (2012)
ISSN
0363-5465
DOI
10.1177/0363546511433032
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
2128102
handle
http://hdl.handle.net/1854/LU-2128102
date created
2012-06-01 10:07:40
date last changed
2015-06-17 10:04:04
@article{2128102,
  abstract     = {Background: A novel, biodegradable, polyurethane scaffold was designed to fulfill an unmet clinical need in the treatment of patients with painful irreparable partial meniscal defects. 
Hypothesis: The use of an acellular polyurethane scaffold for new tissue generation in irreparable partial meniscal defects provides both pain relief and improved functionality. 
Study Design: Case series; Level of evidence, 4. 
Methods: Fifty-two patients with irreparable partial meniscal defects (34 medial and 18 lateral, 88\% with 1-3 previous surgeries on the index meniscus) were implanted with a polyurethane scaffold in a prospective, single-arm, multicenter, proof-of-principle study. Safety was assessed by the rate of scaffold-related serious adverse events (SAEs) and the International Cartilage Repair Society articular cartilage scoring system comparing magnetic resonance imaging (MRI) at 24 months to MRI at baseline (1 week). Kaplan-Meier time to treatment failure distributions were performed. Clinical outcomes were measured comparing visual analog scale, International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Lysholm scores at 24 months from baseline (entry into study). 
Results: Clinically and statistically significant improvements (P {\textlangle} .0001) compared with baseline were reported in all clinical outcome scores (baseline/24 months): visual analog scale (45.7/20.3), International Knee Documentation Committee (45.4/70.1), KOOS symptoms (64.6/78.3), KOOS pain (57.5/78.6), KOOS activities of daily living (68.8/84.2), KOOS sports (30.5/59.0), KOOS quality of life (33.9/56.6), and Lysholm (60.1/80.7), demonstrating improvements in both pain and function. The incidence of treatment failure was 9 (17.3\%) patients, of which 3 patients (8.8\%) had medial meniscal defects and 6 patients (33.3\%) had lateral meniscal defects. There were 9 SAEs requiring reoperation. Stable or improved International Cartilage Repair Society cartilage grades were observed in 92.5\% of patients between baseline and 24 months. 
Conclusion: At 2 years after implantation, safety and clinical outcome data from this study support the use of the polyurethane scaffold for the treatment of irreparable, painful, partial meniscal defects.},
  author       = {Verdonk, Peter and Beaufils, Philippe and Bellemans, Johan and Djian, Patrick and Heinrichs, Eva-Lisa and Huysse, Wouter and Laprell, Heinz and Siebold, Rainer and Verdonk, Ren{\'e}},
  issn         = {0363-5465},
  journal      = {AMERICAN JOURNAL OF SPORTS MEDICINE},
  keyword      = {polyurethane scaffold,meniscectomy,biodegradable scaffold,meniscus,Actifit,partial meniscectomy,meniscal defect,irreparable meniscal defect,ARTHROSCOPIC PARTIAL MENISCECTOMY,PARTIAL LATERAL MENISCECTOMY,OTHERWISE NORMAL KNEE,TERM FOLLOW-UP,RELIABILITY,SCORE,SCALE,RESPONSIVENESS,REPAIR,LYSHOLM KNEE},
  language     = {eng},
  number       = {4},
  pages        = {844--853},
  title        = {Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes},
  url          = {http://dx.doi.org/10.1177/0363546511433032},
  volume       = {40},
  year         = {2012},
}

Chicago
Verdonk, Peter, Philippe Beaufils, Johan Bellemans, Patrick Djian, Eva-Lisa Heinrichs, Wouter Huysse, Heinz Laprell, Rainer Siebold, and René Verdonk. 2012. “Successful Treatment of Painful Irreparable Partial Meniscal Defects with a Polyurethane Scaffold: Two-year Safety and Clinical Outcomes.” American Journal of Sports Medicine 40 (4): 844–853.
APA
Verdonk, Peter, Beaufils, P., Bellemans, J., Djian, P., Heinrichs, E.-L., Huysse, W., Laprell, H., et al. (2012). Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes. AMERICAN JOURNAL OF SPORTS MEDICINE, 40(4), 844–853.
Vancouver
1.
Verdonk P, Beaufils P, Bellemans J, Djian P, Heinrichs E-L, Huysse W, et al. Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes. AMERICAN JOURNAL OF SPORTS MEDICINE. 2012;40(4):844–53.
MLA
Verdonk, Peter, Philippe Beaufils, Johan Bellemans, et al. “Successful Treatment of Painful Irreparable Partial Meniscal Defects with a Polyurethane Scaffold: Two-year Safety and Clinical Outcomes.” AMERICAN JOURNAL OF SPORTS MEDICINE 40.4 (2012): 844–853. Print.