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Orteq Actifit

“Actfit appears to be the next generation solution for painful, irreparable partial meniscus loss” Prof. Rene Verdonk

In the United Kingdom there are 100,000 meniscal repairs each year.  Of these 20,000 patients go on to suffer pain and further joint degradation.

The Actifit implant from Orteq is shown to restore patients to their pre-injury levels of activity by replacing the lost area of meniscus with a scaffold that shares meniscus like characteristics on implantation before remodeling into native tissue.

Features

  • The Actifit is a safe and efficacious option for patients with irreparable partial meniscus damage
  • The Actifit scaffold is robust and easy to implant under standard arthroscopic techniques
  • Over 3,000 implantations have taken place with early patients over 5 years
  • Nice guidance in place for surgeons wishing to carry out the procedure
  • Joint Operations are supporters of the National Ligament Registry

Benefits

 

  • Actifit offers a solution for meniscal deficient patients who otherwise will face a premature joint replacement
  • The scaffold maintains its physical properties until cellular regeneration is complete
  • Trained UK surgeons available throughout the United Kingdom to perform the technique. Please contact Joint Operations for referral suggestions.

Sizing & Product Codes

AM 4508 ActiFit Medial Meniscus Scaffold
AL 3508 ActiFit Lateral Meniscus Scaffold

Clinical Papers

Successful Treatment of Painful Irreparable Partial Meniscal Defects With a Polyurethane Scaffold: Two-Year Safety and Clinical Outcomes

  1. Peter Verdonk, MD, PhD (pverdonk@yahoo.com),
  2. Philippe Beaufils, MD,
  3. Johan Bellemans, MD, PhD,
  4. Patrick Djian, MD,
  5. Eva-Lisa Heinrichs, MD, PhD,
  6. Wouter Huysse, MD,
  7. Heinz Laprell, MD,
  8. Rainer Siebold, MD, PhD,
  9. René Verdonk, MD, PhD and
  10. Actifit Study Group

+Author Affiliations


  1. Department of Orthopaedics and Traumatology, Ghent University Hospital, Ghent, Belgium

  2. Department of Orthopaedic Surgery and Traumatology, Versailles Hospital, Le Chesnay, France

  3. Department Orthopedics, University Hospitals Leuven, Leuven, Belgium

  4. Institut de l’Appareil Locomoteur Nollet, Paris, France

  5. Orteq Limited, London, England

  6. Department of Radiology, Ghent University Hospital, Ghent, Belgium

  7. Department of Trauma Surgery, Arthroscopy and Sports Injury, Lubinus-Clinicum Kiel, Kiel, Germany

  8. ATOS Clinic, Center for Knee and Foot Surgery, Sport Surgery, Heidelberg, Germany

  9. Department of Orthopaedics and Traumatology, Ghent University Hospital, Ghent, Belgium

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.

Orteq Actifit

“Actfit appears to be the next generation solution for painful, irreparable partial meniscus loss” Prof. Rene Verdonk

In the United Kingdom there are 100,000 meniscal repairs each year.  Of these 20,000 patients go on to suffer pain and further joint degradation.

The Actifit implant from Orteq is shown to restore patients to their pre-injury levels of activity by replacing the lost area of meniscus with a scaffold that shares meniscus like characteristics on implantation before remodeling into native tissue.

Features

  • The Actifit is a safe and efficacious option for patients with irreparable partial meniscus damage
  • The Actifit scaffold is robust and easy to implant under standard arthroscopic techniques
  • Over 3,000 implantations have taken place with early patients over 5 years
  • Nice guidance in place for surgeons wishing to carry out the procedure
  • Joint Operations are supporters of the National Ligament Registry

Benefits

 

  • Actifit offers a solution for meniscal deficient patients who otherwise will face a premature joint replacement
  • The scaffold maintains its physical properties until cellular regeneration is complete
  • Trained UK surgeons available throughout the United Kingdom to perform the technique. Please contact Joint Operations for referral suggestions.
Sizing & Product Codes

AM 4508 ActiFit Medial Meniscus Scaffold
AL 3508 ActiFit Lateral Meniscus Scaffold

Clinical Papers

Successful Treatment of Painful Irreparable Partial Meniscal Defects With a Polyurethane Scaffold: Two-Year Safety and Clinical Outcomes

  1. Peter Verdonk, MD, PhD (pverdonk@yahoo.com),
  2. Philippe Beaufils, MD,
  3. Johan Bellemans, MD, PhD,
  4. Patrick Djian, MD,
  5. Eva-Lisa Heinrichs, MD, PhD,
  6. Wouter Huysse, MD,
  7. Heinz Laprell, MD,
  8. Rainer Siebold, MD, PhD,
  9. René Verdonk, MD, PhD and
  10. Actifit Study Group

+Author Affiliations


  1. Department of Orthopaedics and Traumatology, Ghent University Hospital, Ghent, Belgium

  2. Department of Orthopaedic Surgery and Traumatology, Versailles Hospital, Le Chesnay, France

  3. Department Orthopedics, University Hospitals Leuven, Leuven, Belgium

  4. Institut de l’Appareil Locomoteur Nollet, Paris, France

  5. Orteq Limited, London, England

  6. Department of Radiology, Ghent University Hospital, Ghent, Belgium

  7. Department of Trauma Surgery, Arthroscopy and Sports Injury, Lubinus-Clinicum Kiel, Kiel, Germany

  8. ATOS Clinic, Center for Knee and Foot Surgery, Sport Surgery, Heidelberg, Germany

  9. Department of Orthopaedics and Traumatology, Ghent University Hospital, Ghent, Belgium

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.

GET IN TOUCH TO FIND OUT MORE