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A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03087396
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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 Procedure in the foot and/or ankle 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
Insufficiency Fractures Stress Fracture Stress Fracture, Ankle, Foot and Toes Device: Treatment of insufficiency fractures

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 (SCP). Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one bone marrow lesion, such as a cyst or stress fracture confirmed by diagnostic imaging in the foot and/or ankle joint. 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 validated patient reported outcomes measures pre-operatively including the Foot Function Index (FFI) revised short form, the EQ-5D™ and numeric pain score. These measures plus a subject satisfaction survey will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years. At 3 years, 4 years, and 5 years, numeric pain scores and a patient satisfaction survey will be collected. Screening for adverse events and revision surgeries will occur throughout the study.

Target enrollment is 250 patients at up to 25 clinical sites. Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Treatment of insufficiency fractures
    Filling of micro fractures or insufficiency fractures with a bone substitute material


Primary Outcome Measures :
  1. Change from baseline Foot Function Index-Revised (FFI-R) short form score at 12 Months [ Time Frame: 12 months ]
    Change from baseline score, range 0-100, for patient reported pain, stiffness, difficulty, activity limitation and social issues at 12 months.


Secondary Outcome Measures :
  1. Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations [ Time Frame: 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

  2. Change in numeric pain score from baseline at 12 Months [ Time Frame: 12 months ]
    Change in numeric pain score using a 0-10 scale from baseline at 12 months.

  3. Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months [ Time Frame: 12 months ]
    Change in patient quality of life from baseline at 12 months. A scoring function is created using a population preference weighted health index. The change from the baseline score will be measured at 12 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 250 subjects, each with at least one bone marrow lesion (BML) in any of the bones of the foot and/or ankle who have elected to undergo or have undergone the Subchondroplasty (SCP) procedure will be enrolled in the study.
Criteria

Inclusion Criteria:

  • Subject has at least one bone defect such as a bone marrow lesion (BML), cyst or stress fracture confirmed by diagnostic imaging
  • Surgeon considers the patient appropriate for the SCP procedure
  • Subject provides voluntary signature on the Institutional Review Board (IRB) approved Informed Consent
  • Subject is at least 18 years of age
  • Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to complete outcome forms via the internet, telephone or regular mail

Exclusion Criteria:

  • Subject is pregnant at the time of surgery
  • Subject is incarcerated
  • Subject is involved in active litigation related to the condition being treated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087396


Contacts
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Contact: Brittany Nierste, BS 574-373-3994 brittany.nierste@zimmerbiomet.com
Contact: Lynsey Boyle, BS 484-467-7047 lynsey.boyle@zimmerbiomet.com

Locations
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United States, Arizona
OrthoArizona Recruiting
Mesa, Arizona, United States, 85206
Contact: Jason Babcock    480-889-1211    j.babcock@prgresearch.com   
Principal Investigator: Todd Haddon, DPM         
The CORE Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Tayler Dykes    623-455-7142    tayler.dykes@thecoreinstitute.com   
Contact: Susan Mauro, RN    623.455.7125    susan.mauro@thecoreinstitute.com   
Principal Investigator: Jeffrey Holmes, DPM         
Sub-Investigator: Melissa Galli, DPM         
Sub-Investigator: Ryan Scott, DPM         
United States, California
OrthoNorcal Recruiting
Capitola, California, United States, 95010
Contact: Elliot Enshaie, BS    831-475-4024    eenshaie@orthonorcal.com   
Principal Investigator: Nicholas Abidi, MD         
Sub-Investigator: Erica Fisk, MD         
Eisenhower Desert Orthopedic Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Wendy Monaco, RN    760-766-1229    WMonaco@eisenhowerhealth.org   
Principal Investigator: David A Friscia, MD         
Stanford University Medical Center, Orthopedics Recruiting
Redwood City, California, United States, 94063
Contact: Reena Maharaj    650-201-6317    reenam@stanford.edu   
Principal Investigator: David Oji, MD         
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Shari Nichols    916-703-9191    slnichols@ucdavis.edu   
Principal Investigator: Eric Giza, MD         
Sub-Investigator: Chris Kreulen, MD         
United States, Iowa
Capital Orthopaedics and Sports Medicine Recruiting
Clive, Iowa, United States, 50325
Contact: Michael S Lee, DPM    515-440-2676    mlee@dsmcapitalortho.com   
Principal Investigator: Michael S Lee, DPM         
United States, North Carolina
OrthoCarolina Withdrawn
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Podiatry Center of the Lehigh Valley Recruiting
Bethlehem, Pennsylvania, United States, 18018
Contact: Brent H Bernstein, DPM    610-997-0408      
Contact: Callie Brown, BSN    610-997-0408      
Principal Investigator: Brent Bernstein, DPM         
Rothman Institute Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Janet Rhee, BS    267-702-5159    Janet.Rhee@rothmaninstitute.com   
Principal Investigator: David I Pedowitz, MD         
Premier Orthopaedics & Sports Medicine Recruiting
Exton, Pennsylvania, United States, 19341
Contact: Clay Shumway, DPM    610-280-1578    clayshumway27@gmail.com   
Principal Investigator: Jason R Miller, DPM         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Karen Gonzalez, MS    414-805-7386    kgonzalez@mcw.edu   
Principal Investigator: Brian C Law, MD         
Canada, British Columbia
St. Paul's Hospital (Providence Health) Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Biraj Bora, MEng    604-806-8743    BBora@providencehealth.bc.ca   
Principal Investigator: Alastair S Younger, MD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Robert B Anderson, MD OrthoCarolina Research Institute, Inc.
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03087396    
Other Study ID Numbers: KC.CR.I.AM.16.2
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zimmer Biomet:
bone marrow defect
bone marrow lesion
stress fracture
calcium phosphate
bone substitute material
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Stress
Ankle Fractures
Wounds and Injuries