N/A
N=77
SCP Hip Outcomes Study
Subchondral Cysts · Subchondral Bone Edema · Bone Marrow Edema · Insufficiency Fractures · Avascular Necrosis of Hip
Bottom Line
View on ClinicalTrials.gov: NCT03494660 ↗Enrolled (actual)
77
Serious AEs
19.5%
Results posted
Apr 2026
Primary outcome: Primary: Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years — 25.8; 26.3; 24.8 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Subchondroplasty Procedure with AccuFill (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years |
25.8; 26.3; 24.8 | — |
| SECONDARY Pain and Functional Performance by Numeric Pain Scale (NPS) |
2.7; 2.8; 2.6 | — |
| SECONDARY Pain and Functional Performance by Numeric Pain Scale (NPS) |
2.7; 2.8; 2.6 | — |
| SECONDARY Pain and Functional Performance by Numeric Pain Scale (NPS) |
2.7; 2.8; 2.6 | — |
| SECONDARY Pain and Functional Performance by Numeric Pain Scale (NPS) |
2.7; 2.8; 2.6 | — |
| SECONDARY Pain and Functional Performance by Numeric Pain Scale (NPS) |
2.7; 2.8; 2.6 | — |
| SECONDARY Pain and Functional Performance by Numeric Pain Scale (NPS) |
2.7; 2.8; 2.6 | — |
| SECONDARY Modified Harris Hip Score (mHHS) |
82.5; 83.8; 79.4 | — |
| SECONDARY Modified Harris Hip Score (mHHS) |
82.5; 83.8; 79.4 | — |
| SECONDARY Modified Harris Hip Score (mHHS) |
82.5; 83.8; 79.4 | — |
| SECONDARY Modified Harris Hip Score (mHHS) |
82.5; 83.8; 79.4 | — |
| SECONDARY Modified Harris Hip Score (mHHS) |
82.5; 83.8; 79.4 | — |
| SECONDARY Subject Quality-of-life Measured by the EQ-5D-5L Score |
0.5; 0.5; 0.5 | — |
| SECONDARY Subject Quality-of-life Measured by the EQ-5D-5L Score |
0.5; 0.5; 0.5 | — |
| SECONDARY Subject Quality-of-life Measured by the EQ-5D-5L Score |
0.5; 0.5; 0.5 | — |
| SECONDARY Subject Quality-of-life Measured by the EQ-5D-5L Score |
0.5; 0.5; 0.5 | — |
| SECONDARY Subject Quality-of-life Measured by the EQ-5D-5L Score |
0.5; 0.5; 0.5 | — |
| SECONDARY Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS) |
80.2; 79.2; 82.5 | — |
| SECONDARY Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS) |
80.2; 79.2; 82.5 | — |
| SECONDARY Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS) |
80.2; 79.2; 82.5 | — |
| SECONDARY Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS) |
80.2; 79.2; 82.5 | — |
| SECONDARY Subject Quality-Of-Life Measured by the EQ-5D-5L Visual Analog Scale (VAS) |
80.2; 79.2; 82.5 | — |
Summary
Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.
Eligibility Criteria
Inclusion Criteria
- Candidates must meet ALL of the following:
- Surgeon considers the patient appropriate for the SCP Procedure of the hip.
- Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
- Subject provides voluntary signature on the IRB approved Informed Consent Form.
- 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 be compliant with the protocol and complete outcome forms via email, telephone, in-person or by regular mail.
Exclusion Criteria
- Candidates will be excluded if they meet ANY of the following:
- Subject has collapse of subchondral bone.
- Subject is pregnant at the time of surgery.
- Subject is incarcerated.
- Subject is involved in active litigation related to the condition being treated.
- Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Data sourced from ClinicalTrials.gov (NCT03494660). 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.