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

Sponsor

Zimmer Biomet (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03087396

Collaborator

(none)

250

Enrollment

Locations

131.7

Anticipated Duration (Months)

19.2

Patients Per Site

0.1

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Study Design

Study Type:

Observational

Anticipated 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 :

Mar 10, 2017

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2028

Outcome Measures

Primary Outcome Measures

Change from baseline Foot Function Index-Revised (FFI-R) short form score at 12 Months [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

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
Change in numeric pain score from baseline at 12 Months [12 months]
Change in numeric pain score using a 0-10 scale from baseline at 12 months.
Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoArizona	Mesa	Arizona	United States	85206
2	The CORE Institute	Sun City	Arizona	United States	85351
3	OrthoNorcal	Capitola	California	United States	95010
4	Eisenhower Desert Orthopedic Center	Rancho Mirage	California	United States	92270
5	Stanford University Medical Center, Orthopedics	Redwood City	California	United States	94063
6	University of California, Davis	Sacramento	California	United States	95817
7	Capital Orthopaedics and Sports Medicine	Clive	Iowa	United States	50325
8	OrthoCarolina	Charlotte	North Carolina	United States	28207
9	Podiatry Center of the Lehigh Valley	Bethlehem	Pennsylvania	United States	18018
10	Rothman Institute	Bryn Mawr	Pennsylvania	United States	19010
11	Premier Orthopaedics & Sports Medicine	Exton	Pennsylvania	United States	19341
12	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
13	St. Paul's Hospital (Providence Health)	Vancouver	British Columbia	Canada	V6Z 1Y6