Clinical trial · Observational
SCP Hip Outcomes Study
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
NCT03494660CI-TRIAL-00108881completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Avascular Necrosis of Hip | — | UNRESOLVED | — |
| Bone Marrow Edema | — | UNRESOLVED | — |
| Dysplasia; Hip | — | UNRESOLVED | — |
| Femoroacetabular Impingement | — | UNRESOLVED | — |
| Insufficiency Fractures | — | UNRESOLVED | — |
| Subchondral Bone Edema | — | UNRESOLVED | — |
| Subchondral Cysts | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subchondroplasty Procedure with AccuFill | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
- timeFrame
- 2 Years
- description
- Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 2-years. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
Secondary outcomes (21)
- measure
- Pain and Functional Performance by Numeric Pain Scale (NPS)
- timeFrame
- 2 weeks postoperative
- description
- Pain intensity was assessed using the Numeric Pain Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
- measure
- Pain and Functional Performance by Numeric Pain Scale (NPS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Candidates must meet ALL of the following: 1. Surgeon considers the patient appropriate for the SCP Procedure of the hip. 2. Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray. 3. Subject provides voluntary signature on the IRB approved Informed Consent Form. 4. Subject is at least 18 years of age. 5. 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: 1. Subject has collapse of subchondral bone. 2. Subject is pregnant at the time of surgery. 3. Subject is incarcerated. 4. Subject is involved in active litigation related to the condition being treated. 5. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.