cartilage repair center disclosures - s3.eu-central-1 ... · cartilage repair center • technique:...

Cartilage Repair Center

Disclosures

I have the following potential conflicts of interest: Consulting payments/royalties and research support:

- Vericel, Aesculap, Cartiheal, Regentis, JRF, SBM, NuTech, S&N, Exactech

850 Boylston Street

Chestnut Hill, MA 02467

T: 617-732-9967 F: 617-732-9272

www.cartilagerepaircenter.org

Cartilage Repair Center Brigham and Women’s Hospital

Harvard Medical School

Update on Clinical Studies Andreas H. Gomoll, MD

Associate Professor of Orthopaedic Surgery


• I’m sorry!

– If I didn’t quote your study

– If I quoted a study from “that guy…”

– If I didn’t quote enough studies in your field

– If I quoted too many studies outside your field

– If I bored you with detail

– If I didn’t give you enough detail


State of cartilage research


Methodology

• Recent clinical publications on cartilage repair

• Studies that presented something new or

controversial

• Not an exhaustive review

• Food for thought

• Invitation to dig in on your own


• Focus on clinical studies in cartilage repair

– Bone marrow stimulation

– “Microfracture plus”

– Autologous cell based therapy

– Osteochondral autograft

– Osteochondral allograft

– Scaffolds

– PRP

– Stem cells


• Bone marrow stimulation

– Abrasion arthroplasty

– Microfracture

– Subchondral drilling


• Bert J – Arthroscopy (2015)


• Scilla et al. – AJSM (2015)

• 52 NFL players with arthroscopic chondroplasty

• 67% returned to play at 8.2 post-op, average FU 5.9 years

• No correlation with age, lesion size or location, position played or draft round

• Players who also underwent MFX were 4.4x less likely to RTP

• Less is more for professional athletes

• No procedure is a home run, including MFx


• “Microfracture plus”

– Concerns over tissue quality with regular MFx

– Augment to bone marrow stimulation

• Mechanically stabilize clot

• Provide more favorable environment for cell differentiation

• Can be solid scaffold or paste


• Micronized cartilage ECM as an additive to MFx

• 5 horses

• Internal (contralateral knee) control of regular MFx

• Better histology with augmented MFx


• Technique: BST-CarGel® plus MFX VS MFX alone

• Study design: RCT

• Population: n: BST-CarGel®(n = 34) VS (n = 26)MFX,

• Outcomes: WOMAC, SF-36, MOCART. FU: 1y.

• Results:

– MRI analysis: BST-CarGel greater treatment effect for lesion

filling (P = 0.017) and T2 relaxation times

– Overall Clinical improvement, no difference between groups

• Mounting evidence that augments improve tissue quality above simple

MFx. Clinical benefit remains to be determined


• Autologous cell-based therapy

– Chondrocytes

– Cultured or from cartilage fragments


• Technique: Autologous bone graft + autologous cartilage chips

• Study design: case series

• Population: n: 8, OCD lesion in the knee, lesion size 3.1cm2, depth 8.4

mm, age 32.

• Outcomes: IKDC, KOOS, Tegner, MOCART. FU: 1y.

• Results:

– Overall Clinical improvement

• Very interesting development given financial and regulatory reality,

limiting access to cultured cells and allografts


• Technique: RCT ACI vs microfracture

• Population: multicenter, n: 40 ACI vs 40 MFX, FU=15 years.

• Outcomes: Lysholm, Tegner, VAS.

• Results:

– no significant differences between the treatment groups.

– Failure rate 42.5% ACI and 32.5% MFx (p=0.356)

– 4 in each group revised with TKR, and additional 4 each with HTO

– One center with 60% failure rate for ACI

– K-L 2+: 57% ACI and 48% MFx (p>0.05)


• Peterson (AJSM 2010):

• 224 patients average 12.8 years post-op ACI

• 92% satisfaction and would do ACI again

• Minas (CORR 2014):

• 210 patients average 12 years post-op ACI

• 25% failure rate, Better survival with concomitant HTO

• Biant (AJSM 2014)

• 104 patients, minimum 10 years post-op ACI

• 26% failure rate, 98% would do it again

• Claes (KSSTA 2013):

• OA after ACL: 50% in patients with meniscus injury

• High failure rate compared with other long-term studies

• No attention to alignment, meniscal status

• High rate of OA but comparable to ACL

• Avoiding OA is the holy grail, definitely not there yet


• Technique: Case series ACI (synthetic type I/III collagen membrane)

• Population: Patients younger than 18 years, FU=4.6years, mean age

16.7. mean lesion size of 4.0 cm2.

• Outcomes: IKDC, (KOOS-QOL), Short Form–12 (SF-12) and other

KOOS subscores.

• High reoperation rate (37.8%) and limitations in knee function even after

ACI (IKDC 64, KOOS sports 61,

• Good pain relief (KOOS pain 78)

• Important message for patients. Even in an ideal population (young,

healthy, thin), repair of larger defects does not provide a perfect knee. If

that is the goal/promise, then patients will be unhappy


• Technique: Cohort ACI (injected vs seeded collagen membrane)

• Population: 84 patients younger than 18 years, FU=4.6years, mean age

16.7. mean lesion size of 4.0 cm2.

• Outcomes: IKDC, KOOS, MOCART.

• Seeded ACI has same outcomes, possibly lower failure rate, easier

technique, than traditional injection under patch.

• One step closer to less invasive ACI

Gomoll et al. – accepted AJSM 2016


• Osteochondral allograft transplantation

– Regulatory restrictions and supply issues limit

availability

– Expanded storage times to preserve chondrocyte

viability


• 16 dogs implanted with OCA preserved for 28 or 60 days after harvest

• Investigated new storage medium

• Chondrocyte viability at time of implantation 23-99%

• All successful grafts had >70% viability

• No graft with <70% viability was successful


• 32 patients treated with preserved de-cellularized osteochondral allograft

• 72% failure rate, average follow-up 1.3 years

• 43% revision rate

• 19.6% survivorship at 2 years

• Need viable chondrocytes for even short-term survival of OCA graft


• Technique: match-paired cohort: primary OCA (group 1) VS OCA after failure

of previous MFX (group 2). 46 patients in each group

– Previous MFX didn’t affect the survivorship and clinical outcomes.

– Survivorship 87.4% and 86% in groups 1 and 2 at 10 years.

– 87% and 97% in groups 1 and 2 were ‘‘satisfied’’ or ‘‘extremely satisfied”

• ACI after Microfracture with worse results. Criticized for pre-selection bias.

MFx group had failed a procedure before -> knee loser, nothing to do with

microfracture itself.

• Effect disappears once you remove altered subchondral bone


• Technique: case series, OCA transplant limited to the femoral trochlea.

• Population: 29 knees in 28 patients (mean age, 30.2 years), size: 6.1

cm2. Mean FU: 7 years

– Overall survivorship:

• 100% at 5 years

• 91.7% at 10 years

– Satisfaction

• extremely satisfied (63%), very satisfied (26%)

• Excellent outcomes of OCA in trochlea. Have healthy respect for the

technical challenges due to the complex geometry


• PRP and Stem Cells

– Fastest growing area in cartilage repair/OA

treatment research


• Technique: RCT, double-blind, PRP Smart-PReP®2 system (Harvest

Autologous Hemobiologics, Norwell, MA) vs Hyaluronic acid (2 mL of

Hylan G-F 20, Synvisc ; Biomatrix, Inc, Ridgefield, NJ)

• Population: n: 24 PRP vs 34 HA, patients treated for talar chondral

lesion with arthroscopic debridement and microfracture

• Both PRP and HA injections improved outcomes.

• Mechanical and biological components to pain

• We have been carpenters for too long, need to become gardeners (Bill

Bugbee).

• PRP is not like PRP, just like HA is not like HA

• Will take a lot of work to determine “the best” composition for each


• Technique: Cohort 1-stage technique of HA scaffold and BMAC vs MFx

• Population: n: 25 (HA-BMAC) vs 25 MFX, Patients were placed into the

HA-BMAC vs MFx groups based on health insurance coverage of BMAC

– Tegner, IKDC objective, and (KOOS) higher in HA-BMAC

– Lysholm and IKDC subjective: similar

– Worse outcomes in MFX for lesions >4 cm2 and multiple lesions

• Recognition that MFx damages subchondral bone

• BMAC allows higher MSC numbers without violating plate


Summary

Surgical Options 2006 – Microfracture

– Osteochondral Autograft

– Osteochondral Allograft

– Autologous Chondrocyte Implantation


Summary

Surgical Options 2016 – Microfracture

– Microfracture Plus

– Osteochondral Autograft

– Osteochondral Allograft

– Preserved Osteochondral Allograft

– Particulated Juvenile Allograft Cartilage

– Perforated Cryopreserved Allograft Cartilage

– Autologous Chondrocyte Implantation

– Stem Cells


Summary • Many new techniques show structural benefits

• Challenge will be to demonstrate clinical benefits

• Critically evaluate new implants before widespread adoption

• Increased cost consciousness of health systems

• Difficulty for expanded autologous tissue grafts

• Cell-free scaffolds promising but still need to prove themselves

• Osteochondral allograft use has shown excellent results

• Access to allograft tissue remains limited

• Lot of work remains – our jobs are safe…

• Treatment of OA is both biggest challenge and potential

• Start thinking more biological, less mechanical

cartilage repair center disclosures - s3.eu-central-1 ... · cartilage repair center • technique:...

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