Clinical trial NCT03087396: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
Official title: A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insufficiency Fractures
Stress Fracture
Stress Fracture, Ankle, Foot and Toes
Keywords: bone marrow defect
bone marrow lesion
stress fracture
calcium phosphate
bone substitute material
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 140 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.

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.

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, and 2 years. Screening for adverse events and revision surgeries will occur throughout the study.

Target enrollment is 140 patients at up to 25 clinical sites. Subjects will complete the study at 2 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Eligibility 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

Primary outcomes:
measure: Change from baseline Foot Function Index-Revised (FFI-R) short form score at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations
timeFrame: 5 years
measure: Change in numeric pain score from baseline at 12 Months
timeFrame: 12 months
measure: Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Mesa,
country: United States
facility: OrthoArizona
state: Arizona
city: Sun City
country: United States
facility: The CORE Institute
state: Arizona
city: Capitola
country: United States
facility: OrthoNorcal
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Orthopedic Center
state: California
city: Redwood City
country: United States
facility: Stanford University Medical Center, Orthopedics
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Clive
country: United States
facility: Capital Orthopaedics and Sports Medicine
state: Iowa
city: Bethlehem
country: United States
facility: Podiatry Center of the Lehigh Valley
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Exton
country: United States
facility: Premier Orthopaedics & Sports Medicine
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital (Providence Health)
state: British Columbia
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Robert B Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: