NCT00821873

Brief Summary

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2008

Typical duration for phase_3

Geographic Reach
1 country

4 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

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 6, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

3.6 years

First QC Date

January 12, 2009

Results QC Date

August 1, 2013

Last Update Submit

November 6, 2013

Conditions

Knee Injury

Keywords

Cartilage injuryOATSKnee injuryallograftautograft

Outcome Measures

Primary Outcomes (1)

  • MRI to Evaluate Success of Outcome.

    The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.

    24 months

Study Arms (1)

CR Plug BackFill

EXPERIMENTAL

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site

Other: CR Plug

Interventions

CR PlugOTHER

CR Plug will be placed in the harvest site

CR Plug BackFill

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are male or female at least 18 years of age and up to 55 years of age
  • Must be skeletally mature
  • Have a grade III or IV lesion in femoral condyle

You may not qualify if:

  • Skeletally immature
  • Osteoarthritic knees, osteonecrotic knees, osteophyte formation
  • Use of any investigational therapy within thirty (30) days prior to the first visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

American Sports Medicine Institute

Birmingham, Alabama, 35205, United States

Location

The Orthopedic Clinic Assoc

Phoenix, Arizona, 85016, United States

Location

Colorado Orthopedic Consultants

Englewood, Colorado, 80110, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

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. Of the 9 patients enrolled, 4 were lost to follow-up.

Results Point of Contact

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

Study Officials

  • Thomas Carter, MD

    The Orthopedic Clinic, Assoc

    PRINCIPAL INVESTIGATOR

  • David Flanigan, MD

    The Ohio State Univesity

    PRINCIPAL INVESTIGATOR

  • Phillip Stull, MD

    Colorado Orthopedic Consultants

    PRINCIPAL INVESTIGATOR

  • Jeffrey Dugas, MD

    American Sports Medicine Institute

    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

January 12, 2009

First Posted

January 14, 2009

Study Start

December 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 28, 2013

Results First Posted

November 6, 2013

Record last verified: 2013-11

Locations

US(4)