Clinical Data: A Snapshot of Recent Announcements

The correlation among clinical outcomes data, product reimbursement and surgeon adoption is a statement that, frankly, we feel we’ve exhausted. Recent conversations with surgeons and industry experts, though, have revealed that the message bears repeating.

Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company; this is evidenced by the studies summarized below.

Gathering this data takes time and money, two barriers that companies face during collection. Not being armed with important information to make the final sale, though, undermines resources put into R&D, manufacturing, etc. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know how your competition claims product success. Here, we highlight select clinical trial and study announcements made thus far in 2H16.

• Interim results from a U.S. 300+ patient multi-center prospective study of ConforMIS’ iTotal® CR total knee indicate that 92% of patients were satisfied, on average, at one year. The new analysis corroborates a previously-published study demonstrating statistically significantly higher satisfaction rates with iTotal CR vs. off-the-shelf implants in 35 matched pairs of subjects. At one year, 94% of iTotal patients vs. 74% of off-the-shelf patients reported satisfaction with their procedure. ConforMIS has touted its clinical and economic data as an advantage in the bundled-payments era.
• Study results support the biocompatibility of Rotation Medical’s collagen-based bioinductive implant and its ability to promote new connective tissue with the appearance of tendon. (Results are published in the journal Arthroscopy.) The retrospective study included biopsies from seven patients undergoing a subsequent arthroscopic procedure for issues unrelated to the implant at various time points (five weeks to six months) following arthroscopic rotator cuff repair with the bioinductive implant. At six months, newly-generated tissue was observed with histologic appearance of a tendon, suggesting functional loading of the newly-generated host tissue.
• Randomized study results indicate that Safe Orthopaedics’ single-use spine surgical instruments yielded an 80% decrease in pre- and post-operative times. The study assessed 40 surgeries comparing traditional renewable instruments to Safe Orthopaedics’ single-use instruments (1:1) in lumbar fusion. The study showed a reduction of 81% in average logistics times, from 176 to 33 minutes on average, by switching to single-use instruments and eliminating transport, labor and sterilization. No logistical incidents were observed with Safe Orthopaedics’ instruments, vs.15% with the comparison group (e.g., unavailability of instrument set, lack of screws and sterilization problems).
• A study of Silver Bullet Therapeutics’ OrthoFuzIon® Antimicrobial Bone Screw, one of the first antimicrobial implantable medical devices designed specifically for orthopaedics, shows that the screw was able to significantly disrupt the development of biofilms compared to traditional, uncoated titanium screws. The study was designed to test “Time Kill” and “Adherence” effectiveness of OrthoFuzIon against the top six antibiotic resistant superbugs as identified by the CDC. The implant received CE Mark approval in early 2015 and is amassing a portfolio of patents in the U.S. Silver Bullet is one of several companies focused on the costly concern of infection control.
• In 1Q16, Stryker announced construction of an additive manufacturing facility focused on knee and spine implants. In 3Q16, Stryker published pre-clinical study results for its FDA 510(k) cleared 3D-printed Tritanium® PL Interbody Cage. The Tritanium cage demonstrated statistically superior range of motion, bone in-growth profile and greater average construct stiffness vs. PEEK and titanium plasma-sprayed PEEK cages. Specifically, use of the Tritanium cage demonstrated reductions in segmental motion and increases in construct stiffness across all three loading directions between 8- and 16-week post-implant time points, which were not seen within the other two groups.
• Vertera Spine announced initial successful outcomes for its COHERE® Cervical Interbody Fusion Device, reportedly the first device in clinical use to be manufactured entirely from PEEK and contain porosity. COHERE features Scoria® biomaterial that seamlessly integrates with the bulk PEEK implant to support bony tissue ingrowth while retaining mechanical and imaging properties of traditional PEEK implants. Surgeons have reported early signs of fusion with significant bony bridging. Vertera Spine introduced the device at NASS 2015.
• Zimmer Biomet’s 3Q16 acquisition of LDR handed ZBH the Mobi-C®, a 2-level cervical disc backed by data and reimbursement. A seven-year outcomes study demonstrated statistical superiority of ZBH’s Mobi-C Cervical Disc Prosthesis vs. 2-level anterior cervical discectomy and fusion (ACDF) in overall success. The prospective, randomized, controlled trial was conducted as an FDA-regulated Investigational Device Exemption clinical trial. Overall success required improvement in Neck Disability Index, no secondary surgical interventions at index levels and absence of major complications (e.g., radiographic failure, neurological failure or adverse events).

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