SCP® Observational Study of the Knee

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Official Title
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Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study

Conditions
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Bone Marrow Edema

Intervention / Treatment
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* Device: Subchondroplasty Procedure with AccuFill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgeon considers patient appropriate for SCP procedure. Patient has agreed to undergo the SCP procedure or has already undergone the procedure. Subject is willing and able to sign a written consent form. The subject has the mental capacity and the willingness to contribute follow-up outcome data. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months | Change from baseline score of pain intensity at 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations | Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subchondroplasty, Bone Marrow Lesion, Arthroscopy, Bone Substitute Material, AccuFill, Subchondral Bone Defect