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Completed

NCT Number: NCT00821873

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.

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.

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Key information

Conditions

Knee Injury Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

American Sports Medicine Institute, Birmingham, Alabama, United States

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About this study

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

CR Plug

Other

CR Plug will be placed in the harvest site

Primary outcomes

  1. MRI to Evaluate Success of Outcome.

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

RTI Surgical

Industry

Registry information

Official study title

Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure

Acronym: CRB

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 14, 2009
Registry last updated
Nov 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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