Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712191
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : June 19, 2018
Information provided by (Responsible Party):
Active Implants

Brief Summary:
This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.

Condition or disease Intervention/treatment Phase
Meniscus; Degeneration Osteoarthritis, Knee Device: NUsurface Meniscus Implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
Actual Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: NUsurface Meniscus Implant Device: NUsurface Meniscus Implant

Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 24 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
  2. Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
  3. Be in neutral alignment +/- 5 degrees of the mechanical axis.
  4. Be between age 35 and 75 at the time of the planned surgery.
  5. Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
  6. Have a normal mental status.
  7. Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
  8. Be able and willing to understand and sign the informed consent form.

Exclusion Criteria:

  1. Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
  2. Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
  3. Have a varus or valgus knee deformity > 5 degrees.
  4. Have a laxity level of more than II (ICRS), secondary to previous injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL).
  5. Have patella instability or non-anatomically positioned patella
  6. Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
  7. Need a tibial osteotomy at the time of surgery.
  8. Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
  9. Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
  10. Have a knee flexion contracture > 10 degrees
  11. Be unable to flex the knee to 90 degrees
  12. Have a leg length discrepancy causing a noticeable limp.
  13. Have had a previous major knee condyle surgery
  14. Present with insufficiency fractures or avascular necrosis of the medial compartment.
  15. Have an active infection or tumor.
  16. Have any type of knee joint inflammatory disease including Sjogren's syndrome.
  17. Have neuropathic knee osteoarthropathy, also known as Charcot joint.
  18. Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
  19. Be pregnant or is a female intending to become pregnant during the study period.
  20. Be mentally incapacitated.
  21. Be a prisoner.
  22. Be a patient who has economic incentive not to improve (e.g., workman's compensation patient)
  23. Be morbidly Obese (BMI > 35).
  24. Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712191

AZ Monica
Antwerpen, Belgium
Ghent University Hospital
Ghent, Belgium
Sporthopaedicum Berlin
Berlin, Germany
UniKlinikum Regensburg
Regensburg, Germany
Emek Medical Center
Afula, Israel
Tel Aviv Sourasky Medical Center- Ichilov
Tel Aviv, Israel, 64239
Assaf Harofeh Medical Center
Zerifin, Israel
Sacro Cuore- Don Calabria Hospital
Negrar, Italy
Maastricht University Medical Centre
Maastricht, Netherlands
Sahlgrenska universitetssjukhuset
Göteborg, Sweden, 41345
Sponsors and Collaborators
Active Implants

Responsible Party: Active Implants Identifier: NCT01712191     History of Changes
Other Study ID Numbers: 00017
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Keywords provided by Active Implants:

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases