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CC BY-NC-ND 4.0 · J Knee Surg 2025; 38(06): 290-299
DOI: 10.1055/a-2501-0910
Original Article

Prospective Evaluation of Clinical Outcomes of the Subchondroplasty Procedure for Treatment of Symptomatic Bone Marrow Lesions of the Knee

Steven B. Cohen
1   Rothman Institute at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
,
Christopher Hajnik
2   CORE Orthopaedic Medical Center, Orthopaedic Surgeons, Encinitas, California
,
Gregory J. Loren
2   CORE Orthopaedic Medical Center, Orthopaedic Surgeons, Encinitas, California
,
Sam Akhavan
3   Department of Orthopaedic Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania
,
Patrick J. DeMeo
3   Department of Orthopaedic Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania
,
Douglas J. Wyland
4   Prisma Health Steadman Hawkins Clinic of the Carolinas, Greenville, South Carolina
,
Thomas Youm
5   NYU Hospital for Joint Diseases, New York, New York
,
Laith M. Jazrawi
5   NYU Hospital for Joint Diseases, New York, New York
,
Robert J. Daley
6   Hinsdale Orthopaedics, A Division of Illinois Bone and Joint Institute, Hinsdale, Illinois
,
Jack Farr
7   Indiana University School of Medicine and OrthoIndy Hospital, Indianapolis, Indiana
,
Patrick Reischling
8   Zimmer Biomet, Inc. Warsaw, Indiana
,
Jennifer E. Woodell-May 
8   Zimmer Biomet, Inc. Warsaw, Indiana
› Author Affiliations Funding Funding for the study visits and postoperative imaging was provided by Zimmer Biomet, Warsaw, IN.
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Abstract

Bone marrow lesions (BMLs) have a strong correlation to patient-reported pain, functional limitations, joint deterioration, and rapid progression to total knee arthroplasty. The Subchondroplasty (SCP) procedure uses AccuFill, a calcium phosphate bone substitute material (BSM), to treat bone defects such as microtrabecular fractures and BML. This observational, prospective, multicenter, cohort study evaluated the effect of the SCP procedure at the 2-year follow-up for 70 patients with knee BML. Under arthroscopic and fluoroscopic guidance, the BML was injected with AccuFill. Patient-reported outcomes, including Visual Analog Scale (VAS) pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), and modified Knee Society Score (mKSS) were collected through 24 months postoperatively. Radiographs and magnetic resonance imaging (MRI) were performed at baseline and up to 24 months postoperatively. Patient selection was not limited based on the degree of osteoarthritis (OA) as determined radiologically by the Kellgren–Lawrence (K-L) grade. For a subset of patients, patient-reported outcomes were collected up to 5 years including pain evaluation, patient knee global assessment, and satisfaction with the procedure. Preoperative radiographs indicated moderate to severe OA (K-L grades 2–4) in 65 patients (92.8%). Significant improvements (p < 0.0001) in mean VAS pain, IKDC, mKSS, and KOOS scores were observed compared with baseline. Kaplan–Meier survivorship free from conversion to knee arthroplasty was 76.2% at 2 years. The subset of patients followed for 5 years demonstrated low pain scores and high procedure satisfaction. This study presents statistically significant and clinically meaningful evidence of improvement in clinical outcomes following SCP for BMLs of the knee after 2 years. The survivorship rate from arthroplasty at 2 years was 76.2%. SCP for BMLs can relieve pain with a minimally invasive procedure and may delay the need for knee arthroplasty.

Registration NCT01621893 (ClinicalTrials.gov).

Level of Evidence Level II, Prospective Cohort Therapeutic Study.

Keywords

bone marrow lesion - subchondral defect - bone substitute material - AccuFill - Subchondroplasty

Ethical Approval

This study was approved by the WCG IRB Connexus, Princeton, NJ review board (WIRB HRP-2002 protocol number 20120493).


Informed Consent

Each subject enrolled in the study signed an informed consent.


Authors' Contributions

S.B.C., C.H., G.L.L., S.A., P.J.D., D.J.W., T.Y., L.M.J., R.J.D., and J.F. all reviewed and approved the manuscript. P.R. designed the study, drafted, and reviewed the manuscript. J.E.W.M. drafted and reviewed the manuscript.




Publication History

Received: 09 April 2024

Accepted: 10 December 2024

Accepted Manuscript online:
12 December 2024

Article published online:
10 January 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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