SCP® Observational Study of the Knee

Zimmer Biomet516 enrolled

Overview

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.

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.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

OBSERVATIONAL

Enrollment

516

Conditions

Bone Marrow Edema

Interventions

Subchondroplasty Procedure with AccuFillDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Denver-Vail Orthopedics

Parker, Colorado, United States

Atlantis Orthopaedics

Palm Beach Gardens, Florida, United States

Foundation for Orthopaedic Research and Education (FORE)

Outcomes

Primary Outcomes

Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months

Change from baseline score of pain intensity at 12 months. To collect VAS, patients marked a slash on a 10 cm horizontal line, with 0 cm indicating "no pain" and 10 cm indicating "worst possible pain." The distance from the left end of the line to the patient's mark was measured by the administrator in centimeters. Lower numbers were representative of lower pain levels.

Time frame: 12 months

Secondary Outcomes

Occurences 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

Time frame: 5 years

Data from ClinicalTrials.gov

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