NCT00793104

Brief Summary

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2008

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

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

November 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 25, 2013

Completed
Last Updated

December 25, 2013

Status Verified

November 1, 2013

Enrollment Period

3.3 years

First QC Date

November 17, 2008

Results QC Date

July 12, 2013

Last Update Submit

November 6, 2013

Conditions

Knee Injury

Keywords

allograftknee injurycartilage injuryOsteochondral defects in the articular femoral cartilage

Outcome Measures

Primary Outcomes (1)

  • The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months

    The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

    24 months

Secondary Outcomes (4)

  • Current Health Assessment

    24 months, MRI only at 12 and 24 months

  • Lysholm With Tegner Score

    24 months

  • International Knee Documentation Committee (IKDC) at 24 Months.

    24 months

  • MRI Evaluation Score

    24 months

Study Arms (1)

CR Plug

OTHER

Placement of allograft CR Plug in primary injury site

Procedure: Placement of allograft CR Plug in primary injury site

Interventions

Placement of allograft CR Plug in primary injury sitePROCEDURE

Core defect and implant allograft CR plug

CR Plug

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Skeletally mature
  • Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
  • Functional meniscal tissue (defined as 5 mm or more width)
  • A score of = or greater than 4 on the VAS questionnaire

You may not qualify if:

  • Associated tibial or patellar articular cartilage defect greater than 2 ICRS
  • Osteoarthritis of either knee
  • Mechanical axis malalignment of greater than 5 degrees
  • Patellofemoral incongruity of Merchant view
  • One or more multiple defects greater than 2.5 cm
  • Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
  • Ligament treatments in the affected knee within one yer prior to current study
  • Previous surgical meniscus treatments in the affected knee in the last 6 months
  • Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
  • Use of any investigational therapy with in 30 days prior to the first visit
  • Corticosteroid or viscosupplementation within the past 3 months
  • A score of 3 or less on the VAS Questionnaire
  • Active gout or pseudogout or systemic inflammatory condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kerlan Jobe Orthopaedic Clinic

Los Angeles, California, 90045, United States

Location

Colorado Orthopedic Consultants

Denver, Colorado, 80012, United States

Location

OrthoIndy, Inc

Indianapolis, Indiana, 46237, United States

Location

Related Links

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Limitations and Caveats

Enrollment was closed early due for 2 factors: 1\) Slow enrollment and 2) A potential change in the regulatory pathway for allografts used in cartilage repair 1 patient was lost to follow up, with no data collected at the 24-month visit.

Results Point of Contact

Title
Robin Waite , Clinical Projects Director
Organization
RI Biologics
rwaite@rtix.com
386-418-8888

Study Officials

  • Jack Farr, MD, PhD

    OrthoIndy, Inc

    PRINCIPAL INVESTIGATOR

  • Ralph A Gambardella, MD

    Kerlan Jobe Orthopaedic Clinic

    PRINCIPAL INVESTIGATOR

  • Stewart Weinerman, MD

    Colorado Orthopedic Consultants

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

November 17, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

December 25, 2013

Results First Posted

December 25, 2013

Record last verified: 2013-11

Locations

US(3)