ChondroFix 72% failure rate at 2 years

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Anonymous

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ChondroFix 72% failure at 2 years, with a 20% survivorship. Dr Farr is (or was) a consultant to Zimmer.

Paper 41 (2015 AOSSM Presentation Abstracts

http://www.sportsmed.org/uploadedFi...Meeting_2015/AM2015 Full Podium Abstracts.pdf

Decellularized Osteochondral Allograft for the Treatment of Cartilage Lesions in the Knee
Authors: Jack Farr, MD1, guilherme gracitelli, MD2, Andreas H. Gomoll, MD3 1OrthoIndy South, Greenwood, IN, USA, 2 Federal University of Sao Paulo, São Paulo, Brazil, 3Brigham and Women's Hospital, Chestnut Hill, MA, USA

Objectives: Chondrofix® is a pre-shaped cylindrical, decellularized and sterilized osteochondral allograft (OCA). The purpose of this study was to evaluate functional outcomes and graft survivorship among patients treated with this implant for cartilage injuries in the knee.
Methods: An IRB-approved database was used to identify a prospective series of 32 patients who had been treated with the Chondrofix implant. The surgeries were performed in two centers by two surgeons. The mean age ± Standard Deviation (SD) of the patients was 35.1 ± 10.6 years; 59% were male. Twenty-four (75%) knees had previous surgery. The mean defect area ± SD was 2.9 ± 2.0 cm² . The mean allograft size ± SD was 13.18 ± 2.3 mm (6 grafts ≤ 9 mm and 59 grafts ≥11mm). The number and type of reoperations were assessed. Failure was defined as structural damage of the graft diagnosed by arthroscopy or magnetic resonance imaging and any reoperation resulting in removal of the allograft. Patients were evaluated pre- and postoperatively using the Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and Marx Sports Activity Scale.
Results: Twenty-three of the 32 knees (72%) were considered failures, and 14 of the 32 knees (43%) had further surgery following the index procedure. Implant survivorship was 19.6% at 2 years(Graphic). Themmean follow-up duration was 1.29 years (range 0.11- 2.8 years). KOOS Pain, ADL, Sports and Knee relatedQuality of Life (QOL) improved significantly from the preoperative visit to latest follow-up (Table). Age was significantly predictive of failure with hazard ratio of 1.68 per 1SD older (95% CI, 1.05 to 2.68, p = 0.030).

Conclusion: The decellularized and sterile osteochondral allograft implant demonstrated a 72% failure rate within the first 2 years of implantation in these two institutions.
 


Anonymous said:
ChondroFix 72% failure at 2 years, with a 20% survivorship. Dr Farr is (or was) a consultant to Zimmer.

Paper 41 (2015 AOSSM Presentation Abstracts

http://www.sportsmed.org/uploadedFi...Meeting_2015/AM2015 Full Podium Abstracts.pdf

Decellularized Osteochondral Allograft for the Treatment of Cartilage Lesions in the Knee
Authors: Jack Farr, MD1, guilherme gracitelli, MD2, Andreas H. Gomoll, MD3 1OrthoIndy South, Greenwood, IN, USA, 2 Federal University of Sao Paulo, São Paulo, Brazil, 3Brigham and Women's Hospital, Chestnut Hill, MA, USA

Objectives: Chondrofix® is a pre-shaped cylindrical, decellularized and sterilized osteochondral allograft (OCA). The purpose of this study was to evaluate functional outcomes and graft survivorship among patients treated with this implant for cartilage injuries in the knee.
Methods: An IRB-approved database was used to identify a prospective series of 32 patients who had been treated with the Chondrofix implant. The surgeries were performed in two centers by two surgeons. The mean age ± Standard Deviation (SD) of the patients was 35.1 ± 10.6 years; 59% were male. Twenty-four (75%) knees had previous surgery. The mean defect area ± SD was 2.9 ± 2.0 cm² . The mean allograft size ± SD was 13.18 ± 2.3 mm (6 grafts ≤ 9 mm and 59 grafts ≥11mm). The number and type of reoperations were assessed. Failure was defined as structural damage of the graft diagnosed by arthroscopy or magnetic resonance imaging and any reoperation resulting in removal of the allograft. Patients were evaluated pre- and postoperatively using the Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and Marx Sports Activity Scale.
Results: Twenty-three of the 32 knees (72%) were considered failures, and 14 of the 32 knees (43%) had further surgery following the index procedure. Implant survivorship was 19.6% at 2 years(Graphic). Themmean follow-up duration was 1.29 years (range 0.11- 2.8 years). KOOS Pain, ADL, Sports and Knee relatedQuality of Life (QOL) improved significantly from the preoperative visit to latest follow-up (Table). Age was significantly predictive of failure with hazard ratio of 1.68 per 1SD older (95% CI, 1.05 to 2.68, p = 0.030).

Conclusion: The decellularized and sterile osteochondral allograft implant demonstrated a 72% failure rate within the first 2 years of implantation in these two institutions.
Click to expand...

from what I understand he stopped implanting some time ago but continued to follow the patients. is denovo doing any better? not sure. makes you wonder what the long term results for the SCP will be - if there's an underlying bone problem then regardless of what you do, things may be bound to fail. Biologics may be the future, but seems like nothing is really ready for prime time yet. visco injections are hit and miss too, and payor coverage is tough now as a result.
 










Denovo has been around a lot longer and does okay. The cartilage is not as firm as normal knee cartilage, but most patients get relief from it. There's enough clinical evidence out there to say Denovo is a good product for smaller size lesions. Chondrofix only launched two years ago, so this is the first report on it, and it apparently isn't doing well. Fresh allografts and transplanted autograft are the gold standard.
 


Case study presented at AOFAS last week (foot & ankle ortho show) that had reports of Denovo coming off as a single piece when used in the ankle on the talus. Used with Bone Marrow Aspirate. Results no better than microfracture. First report I'd seen like this so it could be technique dependent, or the size of the defect. I've not seen this reported in the knee. I'll attach a link if I can find one. The name of the 5 min talk is below, but it isn't a link.

"Juvenile Allogenous Articular Cartilage and Autologous BMAC in Arthroscopic Treatment of Critical Talar OC Lesions"
 


anonymous said:
Case study presented at AOFAS last week (foot & ankle ortho show) that had reports of Denovo coming off as a single piece when used in the ankle on the talus. Used with Bone Marrow Aspirate. Results no better than microfracture. First report I'd seen like this so it could be technique dependent, or the size of the defect. I've not seen this reported in the knee. I'll attach a link if I can find one. The name of the 5 min talk is below, but it isn't a link.

"Juvenile Allogenous Articular Cartilage and Autologous BMAC in Arthroscopic Treatment of Critical Talar OC Lesions"
Click to expand...

Any luck in finding the link? I had a DeNovo procedure done in late 2014 and it feels good, but interesting in seeing this. Not seeing what you're referring to anywhere.
 


Interesting, but not at all unexpected. Chondrofix is what it is. It is NOT for "average 2.9 CM2" lesions being filled with "average 18+CM2" plugs in patients with an average age of 35.

The lack of knowledge as to proper indications for these procedures is startling. The tx algorithm is pretty straight forward. If it's less than 1 CM in an older, sedentary patient, then yes, Chondrofix MIGHT work. The problem is that most of the time you are turning a chondral defect into an osteochondral defect. Why would anyone with logic want to do that? You would be better off doing a mfx. If one knows anything about cartilage repair (and clearly, the marketing gurus don't), then talk the tx algorithm. Anything 1-5 CM2 goes DeNovo. >5 CM2 goes to ACI. It's a better option for large lesions. Being honest and upfront with customers usually goes a long way.

As for Knee Creations? It's a winner for all involved. Mostly the patients.
 






Why does ChondroFix fail?

-Does it fail because it's stored in water at room temperature for up to 2 years? Water can break down tissue over time, called hydrolysis, which increases in rate with temperature.

-Does it fail because it's likely sterilized by irradiation, which is the only real way to sterilize a graft in water in a closed package? Cartilage reacts poorly to irradiation, it loses it's strength and structure, even at low levels.

-Does it fail because of the mystery processing they do to the graft?
Cartilage is pretty sensitive stuff. They don't tell us what all they use in the processing.

-Does it fail because it was frozen at some point in it's life?
Osteochondral grafts (i.e. ones that include both bone and cartilage together like ChondroFix) that go through a freeze and thaw cycle do poorly in the literature. CryoLife used to sell cryopreserved grafts for cartilage restoration many years ago, which they stopped doing after the grafts had a high failure rate. Its not known if ChondroFix has been frozen or not, but given that Fresh cartilage allografts are NEVER frozen, you would think "never frozen" would be part of their messaging if it were true.

If you still have a surgeon using this, and you value your relationship, consider switching to Denovo.
 








After reading this study I thought it would be nice to let others know that the failure rate for my Chondrofix was less than 3 months from the date of placement. It was placed 9/19/2016 and by 12/12/2016 over half of the graft was MISSING and now the rest of it is gone as well.

Anonymous said:
ChondroFix 72% failure at 2 years, with a 20% survivorship. Dr Farr is (or was) a consultant to Zimmer.

Paper 41 (2015 AOSSM Presentation Abstracts

http://www.sportsmed.org/uploadedFiles/Content2/Education/Meetings/Annual_Meeting_2015/AM2015 Full Podium Abstracts.pdf

Decellularized Osteochondral Allograft for the Treatment of Cartilage Lesions in the Knee
Authors: Jack Farr, MD1, guilherme gracitelli, MD2, Andreas H. Gomoll, MD3 1OrthoIndy South, Greenwood, IN, USA, 2 Federal University of Sao Paulo, São Paulo, Brazil, 3Brigham and Women's Hospital, Chestnut Hill, MA, USA

Objectives: Chondrofix® is a pre-shaped cylindrical, decellularized and sterilized osteochondral allograft (OCA). The purpose of this study was to evaluate functional outcomes and graft survivorship among patients treated with this implant for cartilage injuries in the knee.
Methods: An IRB-approved database was used to identify a prospective series of 32 patients who had been treated with the Chondrofix implant. The surgeries were performed in two centers by two surgeons. The mean age ± Standard Deviation (SD) of the patients was 35.1 ± 10.6 years; 59% were male. Twenty-four (75%) knees had previous surgery. The mean defect area ± SD was 2.9 ± 2.0 cm² . The mean allograft size ± SD was 13.18 ± 2.3 mm (6 grafts ≤ 9 mm and 59 grafts ≥11mm). The number and type of reoperations were assessed. Failure was defined as structural damage of the graft diagnosed by arthroscopy or magnetic resonance imaging and any reoperation resulting in removal of the allograft. Patients were evaluated pre- and postoperatively using the Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and Marx Sports Activity Scale.
Results: Twenty-three of the 32 knees (72%) were considered failures, and 14 of the 32 knees (43%) had further surgery following the index procedure. Implant survivorship was 19.6% at 2 years(Graphic). Themmean follow-up duration was 1.29 years (range 0.11- 2.8 years). KOOS Pain, ADL, Sports and Knee relatedQuality of Life (QOL) improved significantly from the preoperative visit to latest follow-up (Table). Age was significantly predictive of failure with hazard ratio of 1.68 per 1SD older (95% CI, 1.05 to 2.68, p = 0.030).

Conclusion: The decellularized and sterile osteochondral allograft implant demonstrated a 72% failure rate within the first 2 years of implantation in these two institutions.
Click to expand...
 






anonymous said:
Case study presented at AOFAS last week (foot & ankle ortho show) that had reports of Denovo coming off as a single piece when used in the ankle on the talus. Used with Bone Marrow Aspirate. Results no better than microfracture. First report I'd seen like this so it could be technique dependent, or the size of the defect. I've not seen this reported in the knee. I'll attach a link if I can find one. The name of the 5 min talk is below, but it isn't a link.

"Juvenile Allogenous Articular Cartilage and Autologous BMAC in Arthroscopic Treatment of Critical Talar OC Lesions"
Click to expand...
 



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