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NCT03494660
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
trial testing Subchondroplasty Procedure with AccuFill in Subchondral Cysts in 77 participants. Completed in 13 January 2025.
23 October 2023
Quick facts
| Lead sponsor | Zimmer Biomet |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 77 |
| Start date | 27 March 2018 |
| Primary completion | 23 October 2023 |
| Estimated completion | 13 January 2025 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Subchondroplasty Procedure with AccuFill
Conditions studied
- Subchondral Cysts — all drugs for Subchondral Cysts →
- Subchondral Bone Edema — all drugs for Subchondral Bone Edema →
- Bone Marrow Edema — all drugs for Bone Marrow Edema →
- Insufficiency Fractures — all drugs for Insufficiency Fractures →
Sponsor
Zimmer Biomet — full company profile →
Who can join
18 and older, any sex, with Subchondral Cysts or Subchondral Bone Edema. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years
Time frame: 2 Years
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 o
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03494660
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Subchondroplasty Procedure with AccuFill
Trials testing the same drug.
- NCT03110224 — SCP® Observational Study of the Knee · terminated
Other recruiting trials for Subchondral Cysts
Currently open trials in the same condition.
- NCT06388993 — Marrow Cellution™ vs. Traditional BMA Harvest Project · NA · recruiting
Other Zimmer Biomet trials
Trials by the same sponsor.
- NCT06287853 — Tapestry Rotator Cuff Repair PMCF · suspended
- NCT06863428 — Mymobility Knee ROM · recruiting
- NCT06920459 — Zimmer Biomet Shoulder Arthroplasty PMCF Study · recruiting
- NCT07009912 — ROSA® Knee System V1.5 Pilot Study · NA · completed
- NCT06615739 — Comprehensive SRS Regenerex Tissue Attachment · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03494660 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zimmer Biomet
- Last refreshed: 30 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03494660.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing