NCT01712191

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
6 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 6, 2023

Status Verified

June 1, 2018

Enrollment Period

2.9 years

First QC Date

October 18, 2012

Last Update Submit

April 4, 2023

Conditions

Meniscus; DegenerationOsteoarthritis, Knee

Keywords

NUsurfaceMeniscusKneeKOOS

Outcome Measures

Primary Outcomes (1)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    24 Months

Study Arms (1)

NUsurface Meniscus Implant

EXPERIMENTAL
Device: NUsurface Meniscus Implant

Interventions

NUsurface Meniscus ImplantDEVICE
NUsurface Meniscus Implant

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

AZ Monica

Antwerp, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Sporthopaedicum Berlin

Berlin, Germany

Location

UniKlinikum Regensburg

Regensburg, Germany

Location

Emek Medical Center

Afula, Israel

Location

Tel Aviv Sourasky Medical Center- Ichilov

Tel Aviv, 64239, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, Israel

Location

Sacro Cuore- Don Calabria Hospital

Negrar, Italy

Location

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Sahlgrenska universitetssjukhuset

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 23, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

March 1, 2016

Last Updated

April 6, 2023

Record last verified: 2018-06

Locations

DE(2)SE(1)IL(3)NL(1)BE(2)IT(1)