NCT01409447

Brief Summary

Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 22, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

August 3, 2011

Last Update Submit

August 19, 2011

Conditions

Osteochondritis Dissecans

Outcome Measures

Primary Outcomes (1)

  • Knee injury and Osteoarthritis Outcome Score

    1 Year

Study Arms (1)

Biphasic osteochondral composite

EXPERIMENTAL

feasibility study for the new medical device \& technique

Device: Biphasic osteochondral composite

Interventions

Biphasic osteochondral compositeDEVICE

We had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. We further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

Also known as: Biphasic scaffold
Biphasic osteochondral composite

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 \~ 60 years
  • Articular cartilage defect of the knee
  • Diagnosis by X-ray and/or MRI, Arthroscopy
  • Confined area: diameter \< 3 cm
  • Full layer cartilage damage

You may not qualify if:

  • Pregnancy
  • Nonunion of fracture around the knee
  • Diffuse degenerative arthropathy of the knee
  • Diffuse cartilage pathology due to
  • Rheumatism: rheumatoid, psoriatic, …
  • Metabolic disorder: gouty, hemorrhagic, …
  • Stiff knee from any reason
  • Flexion \< 130˚
  • Extension loss \> 20˚

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

OsteochondritisBone DiseasesMusculoskeletal Diseases

Study Officials

  • Chin-Chuan Jiang

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ching-Chuan Jiang

CONTACT

886-23123456ccj@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 4, 2011

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 22, 2011

Record last verified: 2011-08

Locations

TW(1)