SCP® Observational Study of the Knee

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03110224

Collaborator

(none)

516

Enrollment

Locations

123.4

Anticipated Duration (Months)

36.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

516 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study

Actual Study Start Date :

Sep 18, 2012

Actual Primary Completion Date :

Sep 16, 2020

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months [12 months]
Change from baseline score of pain intensity at 12 months.

Secondary Outcome Measures

Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Locations

	Site	City	State	Country	Postal Code
1	Denver-Vail Orthopedics	Parker	Colorado	United States	80134
2	Atlantis Orthopaedics	Palm Beach Gardens	Florida	United States	33410
3	Foundation for Orthopaedic Research and Education (FORE)	Tampa	Florida	United States	33637
4	Southern Ortho	Johns Creek	Georgia	United States	30097
5	OrthoIndy	Indianapolis	Indiana	United States	46143
6	Cascio Sports Medicine	Lake Charles	Louisiana	United States	70601
7	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
8	Orthopaedic Surgical Associates	North Chelmsford	Massachusetts	United States	01863
9	Beaumont Health System	Royal Oak	Michigan	United States	48073
10	Associated Orthopedists	Saint Clair Shores	Michigan	United States	48080
11	New York University School of Medicine	Huntington Station	New York	United States	11746
12	Ohio State University	Columbus	Ohio	United States	43221
13	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
14	Jordan-Young Institute	Virginia Beach	Virginia	United States	23462