Clinical Evidence
01
Role of Bioenhanced Carboplasty Procedure in Managing Medical Knee Osteoarthritis
VAD FOUNDATION - Research and Education Center
Vijay B. Vad MD, Raghav Barve MD, Kaitlin M. Carroll, Chris Topar, Clemente Ibarra MD, Jennifer Solomon MD, Pradeep Albert MD
01
Introduction
This study builds on prior MSC research by treating osteoarthritis as a full bone–cartilage unit disease, emphasizing the biochemical and biomechanical communication between cartilage and subchondral bone to guide more comprehensive therapeutic approaches.
02
Purpose
The goal of this prospective cohort study is to evaluate bioenhanced carboplasty as a potential treatment in relieving pain and improving function in patients with medial knee OA.
03
Methods
The methods describe a 32-patient cohort with the same three symptoms and outline a two-step carboplasty procedure using IV sedation, fluoroscopic guidance, and UCSC injections at the inferior and superior bone-chondral interfaces.
04
Enrollment
Eligible patients were screened and enrolled, consented, treated with bioenhanced carboplasty, and followe up with after 12 months.
05
Results
Among the 32 patients treated, with an average age in the mid-sixties, KOOS JR scores improved by final follow-up, pain significantly decreased, and over half showed positive MRI changes.
06
Conclusions
The study showed significant pain reduction, improved clinical outcomes, and positive MRI changes, suggesting strong early potential, though larger future studies are needed to confirm these results in a broader population.
02
Introduction
01
Previous studies have explored the intra-articular use of MSCs as therapeutic agents in the management of knee osteoarthritis.
02
This study expands upon a newer understanding of osteoarthritis, taking into consideration the biochemical and biomechanical signaling that occurs between articular cartilage and the underlying subchondral bone plate.
03
Understanding this communication necessitates that the treatment of articular cartilage damage should not be confined only to the intra-articular space, but rather should encompass the entire bone-chondral "unit", from articular cartilage down to subchondral bone.
03
Purpose
The goal of this prospective cohort study is to evaluate bioenhanced carboplasty as a potential treatment in relieving pain improving function in patients with medial knee OA.
Fig. 1: Depending on where the cartilage loss is on MRI, the carboplasty instrument can be directed to go to where there is most of the cartilage loss.
Fig. 2: Changes on MRI from pre (left) such as decrease in cartilage fraying or improved cartilage signal as show post (right).
Fig. 1: Depending on where the cartilage loss is on MRI, the carboplasty instrument can be directed to go to where there is most of the cartilage loss.
Fig. 2: Changes on MRI from pre (left) such as decrease in cartilage fraying or improved cartilage signal as show post (right).
04
Methods
There were 32 patients included in this study.
01
All patients had:
-
Minimum of 6 months of symptoms
-
Unicompartmental OA
-
Failed 3 months of conservative treatment
02
Using IV sedation and fluoroscopic guidance, the carboplasty instrument is inserted at inferior bone chondral interface (BCI) and 2.5 of injectate (25 million Umbilical cord derived stem cells UCSC)) are delivered. [ Fig.1]
03
The carboplasty set is removed and then re-inserted at superior BCI to deliver 2.5 cc of injectate (containing 25 million UCSC).
There were 32 patients included in this study.
05
Enrollment
Patients Screened for Eligibility (n=50)
Excluded from Participation
(n=18)
Met Inclusion Criteria:
-
Confirmed >/= KL Grade 3 MCOA, symptomatic for >/= 6 months
-
Failed >/= months of conservative therapy
-
Intact joint space on MRI
Informed consent obtained
(n=32)
Reasons for Exclusion:
-
History of autoimmune disorder
-
History of gout
-
Active infection
-
History of bleeding disorder
-
Unable to commit to research protocol (international travel required)
Proceeded with Bioenhanced Carboplasty Treatment
(n=32)
Completed 12-Month Follow-Up (n=32)
06
Results
32 patients underwent a bioenhanced carboplasty procedure with an average follow-up of 14.53 months
Average age is 64.3 +/- 13.7 years and average BMI of 26. 1 +/- 2.2 kg/m^2
Average KOOS JR score prior to procedure was 44.2 +/- 5.8 comopared to 72.8 +/- 5.8 at final follow-up
There was a significant reduction in pain at final follow up with an average pain decrease of 4 points
On post MRI, 59% of patients had positive changes on MRI such as decrease in cartilage fraying or improved cartilage signal [Fid. 2]
81% of patients had statistically significant change in KOOS JR and pain score
07
Conslusion