Bone Marrow EdemaNCT03110224
SCP® Observational Study of the Knee
An observational study of Bone Marrow Edema, run by Zimmer Biomet at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- Subchondroplasty Procedure with AccuFill
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 516 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Sep 2012to 31 May 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 1. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ohio State University
Columbus, Ohio, 43221
New York University School of Medicine
Huntington Station, New York, 11746
OrthoIndy
Indianapolis, Indiana, 46143
Southern Ortho
Johns Creek, Georgia, 30097
Cascio Sports Medicine
Lake Charles, Louisiana, 70601
Orthopaedic Surgical Associates
North Chelmsford, Massachusetts, 01863
Atlantis Orthopaedics
Palm Beach Gardens, Florida, 33410
Denver-Vail Orthopedics
Parker, Colorado, 80134
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Beaumont Health System
Royal Oak, Michigan, 48073
Associated Orthopedists
Saint Clair Shores, Michigan, 48080
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, 33637
Jordan-Young Institute
Virginia Beach, Virginia, 23462
About this study
Official title: Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study
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.
Read the 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.
- Conditions
- Bone Marrow Edema
- Being tested
- Subchondroplasty Procedure with AccuFill
- Keywords
- Subchondroplasty, Bone Marrow Lesion, Arthroscopy, Bone Substitute Material, AccuFill, Subchondral Bone Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start18 Sep 2012
- Primary completion16 Sep 2020
- Study completion31 May 2023
Why it stopped: Enrollment of 500 subjects was met and Sponsor decided to discontinue enrollment as of July 2018. Sponsor believes enrollment number will provide us with sufficient follow-up to submit a substantial manuscript with minimum of 2 year follow-up data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 516 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Jaggard, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110224
- Sponsor's protocol ID
- KC.CR.I.AM.16.3
- Status last verified
- Dec 2024
- First submitted
- 28 Mar 2017
- Last updated
- 28 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study
- ClinicalTrials.gov ID
- NCT03110224
- Acronym / sponsor ID
- KC.CR.I.AM.16.3
- Conditions
- Bone Marrow Edema
- Keywords
- Subchondroplasty, Bone Marrow Lesion, Arthroscopy, Bone Substitute Material, AccuFill, Subchondral Bone Defect
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment of 500 subjects was met and Sponsor decided to discontinue enrollment as of July 2018. Sponsor believes enrollment number will provide us with sufficient follow-up to submit a substantial manuscript with minimum of 2 year follow-up data.
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2012 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subchondroplasty Procedure with AccuFillInjection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the knee(Subchondroplasty (SCP) Procedure). | Device | – |
Primary outcome
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. 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.
1 secondary outcome
Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Subchondroplasty® (SCP®) ProcedureLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Jaggard study director
Zimmer Biomet
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Edema, run by Zimmer Biomet at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.