Clinical trial NCT03110224: SCP® Observational Study of the Knee
Official title: Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Edema
Keywords: Subchondroplasty
Bone Marrow Lesion
Arthroscopy
Bone Substitute Material
AccuFill
Subchondral Bone Defect
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

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.

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Eligibility 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.

Primary outcomes:
measure: Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations
timeFrame: 5 years
Other outcomes:
Locations:
city: Parker
country: United States
facility: Denver-Vail Orthopedics
state: Colorado
city: Palm Beach Gardens
country: United States
facility: Atlantis Orthopaedics
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education (FORE)
state: Florida
city: Johns Creek
country: United States
facility: Southern Ortho
state: Georgia
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Lake Charles
country: United States
facility: Cascio Sports Medicine
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: North Chelmsford
country: United States
facility: Orthopaedic Surgical Associates
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Saint Clair Shores
country: United States
facility: Associated Orthopedists
state: Michigan
city: Huntington Station
country: United States
facility: New York University School of Medicine
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Jordan-Young Institute
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Charles Jaggard
role: STUDY_DIRECTOR
References: