CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Subchondroplasty with Arthroscopy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03112200
NCT03112200N/ACompleted
CompareCT.gov

A Randomized Controlled Trial of the Subchondroplasty® Procedure With Arthroscopy Versus Arthroscopy Alone for Treatment of Bone Marrow Lesions in the Knee

Zimmer Biomet·interventional·Posted Apr 13, 2017·Updated May 14, 2026

In Brief

A clinical study evaluating Subchondroplasty with Arthroscopy and Arthroscopy Alone for Bone Marrow Edema and 4 related conditions. Completed, enrolled 131 participants across 13 sites in 2 countries.

Detailed Summary

This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone. The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Marrow Edema, Knee Pain Chronic, Knee Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis
CountriesCanada, United States
CollaboratorsMedNet Solutions, Medical Metrics Diagnostics, Inc

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartMar 29, 2017
Primary CompletionAug 23, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.2 years ago

Interventions

Subchondroplasty with Arthroscopyprocedure

The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.

Arthroscopy Aloneprocedure

An endoscopic examination, therapy and surgery of the knee joint.