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SCP® Observational Study of the Knee

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ClinicalTrials.gov Identifier: NCT03110224
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief Summary:
Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the knee in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

Condition or disease Intervention/treatment
Bone Marrow Edema Device: Subchondroplasty Procedure with AccuFill

Detailed Description:

This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure. Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one Bone Marrow Lesion (BML) in the knee. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete patient reported outcomes measures pre-operatively including the Visual Analog Scale (VAS) for knee pain, International Knee Documentation Committee Subject Knee (IKDC) Form and the Veterans Rand 12 (VR-12) Item Health Survey. These measures will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Screening for adverse events and revision surgeries will occur throughout the study.

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study
Actual Study Start Date : September 18, 2012
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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Intervention Details:
  • Device: 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).

Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months [ Time Frame: 12 months ]
    Change from baseline score of pain intensity at 12 months.


Secondary Outcome Measures :
  1. Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations [ Time Frame: 5 years ]
    Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The SCP Observational Cohort Study will enroll either patients undergoing SCP or patients who have already had the SCP procedure for the treatment of BMLs where bone void filler is placed at the site of the BML (defect).
Criteria

Inclusion Criteria:

  1. Surgeon considers patient appropriate for SCP procedure.
  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:

1. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110224


Locations
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United States, Colorado
Denver-Vail Orthopedics
Parker, Colorado, United States, 80134
United States, Florida
Atlantis Orthopaedics
Palm Beach Gardens, Florida, United States, 33410
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, United States, 33637
United States, Georgia
Southern Ortho
Johns Creek, Georgia, United States, 30097
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46143
United States, Louisiana
Cascio Sports Medicine
Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Orthopaedic Surgical Associates
North Chelmsford, Massachusetts, United States, 01863
United States, Michigan
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Associated Orthopedists
Saint Clair Shores, Michigan, United States, 48080
United States, New York
New York University School of Medicine
Huntington Station, New York, United States, 11746
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
United States, Virginia
Jordan-Young Institute
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Lynsey Boyle, BS Zimmer Biomet
More Information
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Additional Information:

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03110224    
Other Study ID Numbers: KC.CR.I.AM.16.3
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Zimmer Biomet:
Subchondroplasty
Bone Marrow Lesion
Arthroscopy
 Bone Substitute Material
AccuFill
Subchondral Bone Defect