Arthroscopy: The Journal of Arthroscopic & Related Surgery
Original ArticleArthroscopic Subchondral Drilling Followed by Injection of Peripheral Blood Stem Cells and Hyaluronic Acid Showed Improved Outcome Compared to Hyaluronic Acid and Physiotherapy for Massive Knee Chondral Defects: A Randomized Controlled Trial
Section snippets
Methods
This is a 24-month dual-center, open-label phase IIB randomized controlled trial (RCT) conducted as part of an Investigational New Drug application reviewed and cleared by the US Food and Drug Administration (IND 15993). Institutional review board approval was obtained from the Medical Research and Ethics Committee (Ministry of Health Malaysia) from the Malaysian site and the Baptist Hospital System of Pensacola, Florida, from the US site.
An independent data safety monitoring committee (DSMC)
Results
The protocol-defined interim analysis was performed and the results presented to the DSMC. Early closure of the study was recommended by the DSMC due to overwhelming statistical significance seen at 2 years in the absence of any safety concerns. Enrollment was halted in March 2020, and the study was therefore concluded prior to the recruitment of the 120 patients as originally designed.
At the point of halting study enrollment, the total recruited patients in this study were 81 (control, 38;
Discussion
The results of this RCT evaluating intra-articular injections of autologous PBSCs plus HA after arthroscopic subchondral drilling into massive chondral defects of the knee joint showed that this cartilage repair technique is safe and effective, with improved knee function and pain reduction better than HA plus physiotherapy. Improvements for the intervention group in the subjective IKDC (P < .0001) and KOOS-pain subdomain scores (P < .0001) were statistically significant at 24 months compared
Conclusions
Arthroscopic marrow stimulation with subchondral drilling into massive chondral defects of the knee joint followed by postoperative intra-articular injections of autologous PBSCs plus HA is safe and showed a significant improvement in clinical and radiologic scores as compared with HA plus physiotherapy.
Acknowledgment
This study is sponsored by KLSMC Stem Cells Inc and supported by grants from City of Gulf Breeze, Florida, and the State of Florida. The authors thank Dr Surinder Kaur, Ms Malar Muniandy, Ms Amal Mohd Dawam, Ms Alisha Ramlan, Ms Jocelyn Dowse, Ms Casandra Tan, and Mr Wai Choong Koh from Kuala Lumpur Medicine Centre, Malaysia; Dr Candace Anz, Dr Josh Hackel, Mr Johnny Torres, and Ms Mikala McMillion at the Andrews Research and Education Foundation, U.S.A.; and Dr Thong Chwee Ling, Dr Raja Kumar
References (44)
- et al.
Marrow stimulation and chondrocyte transplantation using a collagen matrix for cartilage repair
Osteoarthr Cartil
(2005) - et al.
Surgical treatments of cartilage defects of the knee: Systematic review of randomized controlled trials
Knee
(2017) - et al.
Knee cartilage repair and restoration: Common problems and solutions
Clin Sports Med
(2018) - et al.
Evaluation of intra-articular mesenchymal stem cells to augment healing of microfractured chondral defects
Arthroscopy
(2011) - et al.
Articular cartilage regeneration with autologous marrow aspirate and hyaluronic acid: An experimental study in a goat model
Arthroscopy
(2009) - et al.
Articular cartilage regeneration with autologous peripheral blood progenitor cells and hyaluronic acid after arthroscopic subchondral drilling: A report of 5 cases with histology
Arthroscopy
(2011) - et al.
Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: A randomized controlled trial
Arthroscopy
(2013) - et al.
High tibial osteotomy in combination with chondrogenesis after stem cell therapy: A histologic report of 8 cases
Arthroscopy
(2015) - et al.
Repair of large full-thickness cartilage defect by activating endogenous peripheral blood stem cells and autologous periosteum flap transplantation combined with patellofemoral realignment
Knee
(2014) - et al.
Definition of pertinent parameters for the evaluation of articular cartilage repair tissue with high-resolution magnetic resonance imaging
Eur J Radiol
(2004)
Autologous chondrocyte implantation versus microfracture in the knee: A meta-analysis and systematic review
Arthroscopy
Failures and reoperations after matrix-assisted cartilage repair of the knee: A systematic review
Arthroscopy
Evidence-based status of microfracture technique: A systematic review of level I and II studies
Arthroscopy
Autologous osteochondral mosaicplasty for the treatment of full-thickness defects of weight-bearing joints: Ten years of experimental and clinical experience
J Bone Joint Surg Am
A randomized multicenter trial comparing autologous chondrocyte implantation with microfracture: Long-term follow-up at 14 to 15
J Bone Joint Surg Am
Overview of existing cartilage repair technology
Sports Med Arthrosc Rev
Autologous chondrocyte implantation (ACI) for knee cartilage defects: A review of indications, technique and outcomes
JBJS Rev
Treatment of focal articular cartilage defects in the knee: A systematic review
Clin Orthop Relat Res
An expert consensus statement on the management of large chondral and osteochondral defects in the patellofemoral joint
Orthop J Sports Med
Changing trends in the use of cartilage restoration techniques for the patellofemoral joint: A systematic review
Knee Surg Sports Traumatol Arthrosc
Hyaluronic acid viscosupplementation and osteoarthritis: Current uses and future directions
Am J Sports Med
Current strategies for nonsurgical, arthroscopic, and minimally invasive surgical treatment of knee cartilage pathology
Instr Course Lect
Cited by (0)
The authors report the following potential conflicts of interest or sources of funding: This study is sponsored by KLSMC Stem Cells Inc and supported by grants from City of Gulf Breeze, Florida, and the State of Florida. Full ICMJE author disclosure forms are available for this article online, as supplementary material.