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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712191
• Other study ID #: 00017
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: March 2016

Study information

• Verified date: June 2018
• Source: Active Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus; Degeneration
• Osteoarthritis, Knee

Intervention

Device:
• NUsurface Meniscus Implant

Locations

Country	Name	City	State
Belgium	AZ Monica	Antwerpen
Belgium	Ghent University Hospital	Ghent
Germany	Sporthopaedicum Berlin	Berlin
Germany	UniKlinikum Regensburg	Regensburg
Israel	Emek Medical Center	Afula
Israel	Tel Aviv Sourasky Medical Center- Ichilov	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Sacro Cuore- Don Calabria Hospital	Negrar
Netherlands	Maastricht University Medical Centre	Maastricht
Sweden	Sahlgrenska universitetssjukhuset	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Active Implants

Countries where clinical trial is conducted

Belgium,  Germany,  Israel,  Italy,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS)		24 Months