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

Status: Completed
Location: See all (12) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
OrthoArizona
Mesa,
The CORE Institute
Sun City
California
OrthoNorcal
Capitola
Eisenhower Desert Orthopedic Center
Rancho Mirage
Stanford University Medical Center, Orthopedics
Redwood City
University of California, Davis
Sacramento
Iowa
Capital Orthopaedics and Sports Medicine
Clive
Pennsylvania
Podiatry Center of the Lehigh Valley
Bethlehem
Rothman Institute
Bryn Mawr
Premier Orthopaedics & Sports Medicine
Exton
Wisconsin
Medical College of Wisconsin
Milwaukee
Other Locations
Canada
St. Paul's Hospital (Providence Health)
Vancouver
Time Frame
Start Date: 2017-03-10
Completion Date: 2023-08-23
Participants
Target number of participants: 148
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov