Amniox Medical, Inc., a TissueTech, Inc. company, recently released encouraging data from its pilot study on the adjunctive use of umbilical cord (UC) allograft to improve clinical and functional outcomes after arthroscopic repair of talar osteochondral defects (OCD).
Umbilical Cord Allograft May Improve Ankle Repair Outcomes
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The single-center pilot study, “Arthroscopic Repair of Talar Osteochondral Defects With Umbilical Cord Allograft: A Prospective, Single-Center, Pilot Study,” published March 14, 2020 in the Foot & Ankle Specialist. included 10 patients with talar osteochondral defects that did not respond to conservative nonsurgical treatment. Clinical and functional outcomes were assessed at 6,12, 24, and 52 weeks postoperatively.
Murray Penner, M.D., clinical professor in the department of orthopedics at the University of British Columbia and head of the regional department of orthopedics for Vancouver Coastal Health Authority & Providence Health Care, and his colleagues found consistent improvement in all outcome measures, including postoperative pain and inflammation, range of motion, and overall recovery.
Visual Analog Scale (VAS) scores improved from 4.2±2.9 to 1.3±2.2 at 52 weeks (p = 0.15). Ankle Osteoarthritis Scale (AOS) difficulty and pain scores also improved but not significantly.
Previous studies have highlighted cryopreserved umbilical cord allograft’s anti-inflammatory and anti-scarring properties.
The study authors wrote, “The clinical outcome improvement was accompanied by significant reduction in OCD defect size and associated bone marrow lesion. This pilot study suggests that adjunctive use of UC during arthroscopic repair of talar OCD may lead to clinical and functional improvement.”
Herbert Slade, M.D., chief medical officer at TissueTech added, “A large percentage of patients with OCDs require surgical intervention because up to 50% of all patients fail to improve with conservative treatment. Adjunctive use of CLARIX Cord 1K, the cryopreserved umbilical cord allograft used in this study, during arthroscopic repair of OCD may lead to clinical and functional improvement for this patient population.”
“By modulating inflammation, cryopreserved UC allograft may help expedite healing and manage scar tissue formation in arthroscopic repair of talar osteochondral defects in the ankle joint. We are encouraged by these results with a limited sample size and look forward to further controlled, prospective studies with a larger sample size to help confirm these clinical benefits,” he said.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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