Clinical trial NCT01712191: Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
Official title: Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscus; Degeneration
Osteoarthritis, Knee
Keywords: NUsurface
Meniscus
Knee
KOOS
Lead sponsor: Active Implants
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 128
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Berlin
country: Germany
facility: Sporthopaedicum Berlin
city: Regensburg
country: Germany
facility: UniKlinikum Regensburg
city: Afula
country: Israel
facility: Emek Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center- Ichilov
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Negrar
country: Italy
facility: Sacro Cuore- Don Calabria Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Göteborg
country: Sweden
facility: Sahlgrenska universitetssjukhuset
Study officials:
References: