Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
516 participants
OBSERVATIONAL
2012-09-18
2023-05-31
Brief Summary
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Detailed Description
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Target enrollment is 1000 subjects at up to 30 clinical sites. Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
Conditions
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Study Design
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COHORT
OTHER
Interventions
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Subchondroplasty Procedure with AccuFill
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the knee(Subchondroplasty (SCP) Procedure).
Eligibility Criteria
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Inclusion Criteria
2. Patient has agreed to undergo the SCP procedure or has already undergone the procedure.
3. Subject is willing and able to sign a written consent form.
4. The subject has the mental capacity and the willingness to contribute follow-up outcome data.
5. Patient is willing and able to complete outcome forms in person or by phone, email or regular mail.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Jaggard
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Denver-Vail Orthopedics
Parker, Colorado, United States
Atlantis Orthopaedics
Palm Beach Gardens, Florida, United States
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, United States
Southern Ortho
Johns Creek, Georgia, United States
OrthoIndy
Indianapolis, Indiana, United States
Cascio Sports Medicine
Lake Charles, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Orthopaedic Surgical Associates
North Chelmsford, Massachusetts, United States
Beaumont Health System
Royal Oak, Michigan, United States
Associated Orthopedists
Saint Clair Shores, Michigan, United States
New York University School of Medicine
Huntington Station, New York, United States
Ohio State University
Columbus, Ohio, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
Jordan-Young Institute
Virginia Beach, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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The Subchondroplasty® (SCP®) Procedure
Other Identifiers
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KC.CR.I.AM.16.3
Identifier Type: -
Identifier Source: org_study_id
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