N/A
N=148
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle
Insufficiency Fractures · Stress Fracture · Stress Fracture, Ankle, Foot and Toes
Bottom Line
View on ClinicalTrials.gov: NCT03087396 ↗Enrolled (actual)
148
Serious AEs
16.9%
Results posted
Apr 2026
Primary outcome: Primary: Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months — 42.8; 43.0; 39.6 Percentage scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Treatment of insufficiency fractures (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months |
42.8; 43.0; 39.6 | — |
| SECONDARY Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks |
3.4; 3.4; 3.3 | — |
| SECONDARY Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form |
59.2; 59.5; 52.5 | — |
| SECONDARY Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form |
51.5; 51.4; 55.0 | — |
| SECONDARY Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form |
48.1; 48.2; 46.4 | — |
| SECONDARY Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form |
45.7; 45.7; 47.3 | — |
| SECONDARY Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS) |
3.4; 3.4; 3.3 | — |
| SECONDARY Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS) |
3.5; 3.5; 4.8 | — |
| SECONDARY Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS) |
3.3; 3.3; 3.2 | — |
| SECONDARY Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS) |
3.2; 3.2; 3.8 | — |
| SECONDARY Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS) |
2.9; 2.9; 2.0 | — |
| SECONDARY Subject Quality-of-life at 6-weeks by the EQ-5D |
0.6; 0.6; 0.7 | — |
| SECONDARY Subject Quality-of-life at 3-months by the EQ-5D |
0.7; 0.7; 0.7 | — |
| SECONDARY Subject Quality-of-life at 6-months by the EQ-5D |
0.7; 0.7; 0.6 | — |
| SECONDARY Subject Quality-of-life at 1-year by the EQ-5D |
0.7; 0.7; 0.6 | — |
| SECONDARY Subject Quality-of-life at 2-years by the EQ-5D |
0.8; 0.8; 0.9 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03087396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.