Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
This study is currently recruiting participants.
Verified October 2012 by Active Implants
Sponsor:
Active Implants
Information provided by (Responsible Party):
Active Implants
ClinicalTrials.gov Identifier:
NCT01712191
First received: October 18, 2012
Last updated: October 22, 2012
Last verified: October 2012
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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: | February 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:
- Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
- Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
- Be in neutral alignment +/- 5 degrees of the mechanical axis.
- Be between age 35 and 75 at the time of the planned surgery.
- Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
- Have a normal mental status.
- Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
- Be able and willing to understand and sign the informed consent form.
Exclusion Criteria:
- Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
- Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
- Have a varus or valgus knee deformity > 5 degrees.
- 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).
- Have patella instability or non-anatomically positioned patella
- Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
- Need a tibial osteotomy at the time of surgery.
- Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device
- Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic.
- Have a knee flexion contracture > 10 degrees
- Be unable to flex the knee to 90 degrees
- Have a leg length discrepancy causing a noticeable limp.
- Have had a previous major knee condyle surgery
- Present with insufficiency fractures or avascular necrosis of the medial compartment.
- Have an active infection or tumor.
- Have any type of knee joint inflammatory disease including Sjogren's syndrome.
- Have neuropathic knee osteoarthropathy, also known as Charcot joint.
- Have any medical condition that does not allow arthroscopy at the point of entry to the knee.
- Be pregnant or is a female intending to become pregnant during the study period.
- Be mentally incapacitated.
- Be a prisoner.
- Be a patient who has economic incentive not to improve (e.g., workman's compensation patient)
- Be morbidly Obese (BMI > 35).
- Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712191
Contacts
| Contact: Richard W Treharne, PhD | 901-762-0352 | rick.treharne@activeimplants.com |
| Contact: Emanuele Nocco, M.S. | emanuele.nocco@activeimplants.com |
Locations
| Belgium | |
| Ghent University Hospital | Recruiting |
| Ghent, Belgium | |
| Principal Investigator: Peter Verdonk, MD | |
| Germany | |
| Sporthopaedicum Berlin | Recruiting |
| Berlin, Germany | |
| Principal Investigator: Andreas Weiler, MD, PhD | |
| UniKlinikum Regensburg | Recruiting |
| Regensburg, Germany | |
| Principal Investigator: Peter Angele, MD | |
| Israel | |
| Emek Medical Center | Recruiting |
| Afula, Israel | |
| Principal Investigator: Nimrod Rozen, MD, PhD | |
| Assaf Harofeh Medical Center | Recruiting |
| Beer Yaakoav, Israel | |
| Principal Investigator: Gabriel Agar, MD | |
| Tel Aviv Sourasky Medical Center- Ichilov | Recruiting |
| Tel Aviv, Israel, 64239 | |
| Principal Investigator: Ron Arbel, MD | |
| Italy | |
| Sacro Cuore- Don Calabria Hospital | Recruiting |
| Negar, Italy | |
| Principal Investigator: Vincenzo Condello, MD | |
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: | October 22, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Active Implants:
|
NUsurface Meniscus Knee KOOS |
ClinicalTrials.gov processed this record on May 21, 2013