Trial results for the Subchondroplasty® Knee RCT, investigating treatment for osteoarthritis and bone marrow lesions, were posted on ClinicalTrials.gov on 2026-05-14. The study demonstrated superiority of Subchondroplasty with arthroscopy over arthroscopy alone for composite clinical success, with a p-value of 0.01.
Background
Osteoarthritis is a degenerative joint disease often associated with chronic knee pain and bone marrow edema. Current treatments aim to alleviate symptoms and improve joint function. This trial specifically sought to demonstrate the superiority of Subchondroplasty combined with arthroscopy compared to arthroscopy alone for treating bone marrow lesions (BMLs) in the knee, which are often implicated in osteoarthritis progression and pain.
Trial design
This multi-center, prospective, single-blinded, two-arm study was randomized to include 131 enrolled subjects. The trial investigated conditions such as Bone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee, and Osteoarthritis. The intervention arm involved treatment with Subchondroplasty (SCP) + Arthroscopy, while the comparator arm received arthroscopy alone. The primary objective was to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for the treatment of Bone Marrow Lesions (BMLs) in the knee.
Key results
The study reported on several key measurements:
- Composite Clinical Success:
- In the Subchondroplasty With Arthroscopy group, 68 participants achieved composite clinical success.
- In the Arthroscopy Alone group, 38 participants achieved composite clinical success.
- Additional measurements for Composite Clinical Success showed 16 participants in the Subchondroplasty With Arthroscopy group and 4 participants in the Arthroscopy Alone group.
- Further measurements indicated 4 participants in the Subchondroplasty With Arthroscopy group and 1 participant in the Arthroscopy Alone group.
- Change From Baseline KOOS Subscale Scores at 12 Months:
- For the Subchondroplasty With Arthroscopy group, the mean score was 73.3 (Standard Deviation 21.0) on a scale.
- For the Arthroscopy Alone group, the mean score was 79.4 (Standard Deviation 22.7) on a scale.
- Another mean score for the Subchondroplasty With Arthroscopy group was 79.3 (Standard Deviation 19.8) on a scale.
- Another mean score for the Arthroscopy Alone group was 83.5 (Standard Deviation 21.6) on a scale.
- A third mean score for the Subchondroplasty With Arthroscopy group was 71.3 (Standard Deviation 19.9) on a scale.
- A third mean score for the Arthroscopy Alone group was 76.8 (Standard Deviation 19.8) on a scale.
A key analysis using the Fisher Exact method for composite clinical success reported a p-value of 0.01, with a difference in proportions of 0.095. The 95.0% confidence interval for this difference was [-0.027, 0.217].
What this means
The statistically significant p-value of 0.01 for composite clinical success suggests that Subchondroplasty combined with arthroscopy offers a superior outcome compared to arthroscopy alone in treating bone marrow lesions in the knee, a common factor in osteoarthritis. While the mean KOOS subscale scores at 12 months were generally higher in the arthroscopy alone group, the specific statistical analysis for these differences was not provided in the key analyses. The primary finding indicates a benefit for the combined Subchondroplasty and arthroscopy approach in achieving overall clinical success.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03112200, titled "Subchondroplasty® Knee RCT", were posted on 2026-05-14 on clinicaltrials.gov.