NCT03219307

Brief Summary

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
32mo left

Started Nov 2018

Longer than P75 for phase_3

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

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 Progress74%
Nov 2018Jan 2029

First Submitted

Initial submission to the registry

July 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Expected
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

7.1 years

First QC Date

July 13, 2017

Last Update Submit

March 19, 2025

Conditions

Articular Cartilage Defect

Keywords

cartilage repaircartilage regenerationcartilage reconstructioncartilage restorationautologous chondrocyte implantationmatrix associated chondrocyte implantation

Outcome Measures

Primary Outcomes (1)

  • KOOS pain subdomain score

    Comparison of pain scores from the KOOS questionnaire from baseline

    24 months

Secondary Outcomes (3)

  • KOOS function subdomain score

    24 months

  • VAS pain scale

    24 months

  • IKDC subjective scores

    24 months

Study Arms (1)

NOVOCART 3D

EXPERIMENTAL

Matrix associated autologous chondrocyte implant

Combination Product: NOVOCART 3D

Interventions

NOVOCART 3DCOMBINATION_PRODUCT

Matrix associated autologous chondrocyte implant

NOVOCART 3D

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participated in study AAG-G-H-1220
  • identified as a microfracture failure patient
  • voluntary consent to participate in the study

You may not qualify if:

  • other cartilage repair procedures performed on target knee
  • other conditions that would interfere with healing or evaluating outcomes
  • lesions requiring implants larger than 9cm2
  • non-compliance with requirements in study AAG-G-H-1220

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43202, United States

Location

Alpine Orthopaedics

North Logan, Utah, 84341, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 2E1, Canada

Location

Related Links

Study Officials

  • Robert Spiro, PhD

    Octane Biotherapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 17, 2017

Study Start

November 30, 2018

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2029

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)CA(2)