18 and older, any sex, with Bone Marrow Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 MonthsPrimary· 12 months
Change from baseline score of pain intensity at 12 months. To collect VAS, patients marked a slash on a 10 cm horizontal line, with 0 cm indicating "no pain" and 10 cm indicating "worst possible pain." The distance from the left end of the line to the patient's mark was measured by the administrator in centimeters. Lower numbers were representative of lower pain levels.
Baseline
Group
Value
95% CI
Primary Outcome Measure
6.8
6.6 – 7.0
12 Months
Group
Value
95% CI
Primary Outcome Measure
3.6
3.3 – 4.0
Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operationsSecondary· 5 years
Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure
Events Related to SCP
Group
Value
95% CI
Secondary Outcome Measure
36
Events Unrelated to SCP
Group
Value
95% CI
Secondary Outcome Measure
72
Revisions
Group
Value
95% CI
Secondary Outcome Measure
72
Adverse events — posted to ClinicalTrials.gov
Time frame: Surgery, 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Adverse Events
Serious: 83/516 (16%)
Deaths: 3/516
Serious adverse events (33 terms)
Reaction
System
Adverse Events
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
Increased Knee Pain
Musculoskeletal and connective tissue disorders
—
Chondrosis: Patella and Medial Femoral Condyle
Musculoskeletal and connective tissue disorders
—
Complex tear of medial meniscus of right knee
Musculoskeletal and connective tissue disorders
—
Extensive chondrosis medial femoral condyle and medial tibial plateau
Musculoskeletal and connective tissue disorders
—
Fall
General disorders
—
Increased grinding and retropatellar pain
Musculoskeletal and connective tissue disorders
—
Infected right knee
Musculoskeletal and connective tissue disorders
—
Known patellar chondrosis with recurrent effusions and pain
Musculoskeletal and connective tissue disorders
—
Osteoarthritis with fracture
Musculoskeletal and connective tissue disorders
—
Persistence of patellofemoral pain not responsive to conservative management.
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 (SCP) Procedure in the knee in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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: 28 October 2025
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/NCT03110224.