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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Active Implants
ClinicalTrials.gov Identifier:
NCT01712191
First received: October 18, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Treating the Meniscally Deficient Knee.
Device: NUsurface Meniscus Implant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant

Further study details as provided by Active Implants:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: NUsurface Meniscus Implant Device: NUsurface Meniscus Implant

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712191

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

No publications provided

Responsible Party: Active Implants
ClinicalTrials.gov Identifier: NCT01712191     History of Changes
Other Study ID Numbers: 00017
Study First Received: October 18, 2012
Last Updated: December 18, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Active Implants:
NUsurface
Meniscus
Knee
KOOS

ClinicalTrials.gov processed this record on August 28, 2014