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

NCT03087396 | Completed Results FDA Device

• 1 other identifier: KC.CR.I.AM.16.2
• Study Type: observational
• Target: 148
• Locations: 2 countries
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (1)

• Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months

  Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.

  24 months

Secondary Outcomes (15)

• Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks

  6 weeks postoperative

• Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form

  6 weeks postoperative

• Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form

  3 Months postoperative

• Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form

  6 Months postoperative

• Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form

  1 Year postoperative

Interventions

Treatment of insufficiency fractures DEVICE

Filling of micro fractures or insufficiency fractures with a bone substitute material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (12)

OrthoArizona

Mesa, Arizona, 85206, United States

Location

The CORE Institute

Sun City, Arizona, 85351, United States

Location

OrthoNorcal

Capitola, California, 95010, United States

Location

Eisenhower Desert Orthopedic Center

Rancho Mirage, California, 92270, United States

Location

Stanford University Medical Center, Orthopedics

Redwood City, California, 94063, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Capital Orthopaedics and Sports Medicine

Clive, Iowa, 50325, United States

Location

Podiatry Center of the Lehigh Valley

Bethlehem, Pennsylvania, 18018, United States

Location

Rothman Institute

Bryn Mawr, Pennsylvania, 19010, United States

Location

Premier Orthopaedics & Sports Medicine

Exton, Pennsylvania, 19341, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

St. Paul's Hospital (Providence Health)

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Annette Tieu, Clinical Research Specialist
• Organization: Zimmer Biomet

annette.tieu@zimmerbiomet.com

971-482-9622

Study Officials

• Robert B Anderson, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 22, 2017
• Study Start: March 10, 2017
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); CA (1)