Orthopedic Device Trials: Statistical and Technology Solutions

According to a recent report (Millennium Research Group), the orthopedic device market is growing steadily, and this is due to several changing factors in the industry. There has been a significant increase in devices for the treatment of extremities including devices for hands, wrists, elbows, shoulders, feet and ankles. This market change is due to both an aging population that is still physically active and an increase in the number of sports related injuries.

What does this mean for device development and clinical trials?

Orthopedic device development is a rather saturated market, however device companies have the opportunity to develop new devices to meet market demand and streamline trial costs for more “mature” products such as hip implants through a clinical trial strategy that combines smart trial design and integrated technology.

Combining the right statistical solutions with an eClinical platform can result in up to 20-30% cost savings.

Statistical Solutions

Reducing uncertainty in the planning phase of orthopedic device development can eventually reduce timelines, and inevitably, costs. Statistical methods in device studies test for proof of safety and efficacy and also an estimation of effects.

Involving an expert biostatistician from the beginning can help with the protocol development and study design, especially in the areas of adaptive trial design. Since statisticians in orthopedic device trials must balance potentially expensive products, long follow-up periods, possibly large sample sizes, and unique endpoints, adaptive trial design can help account for these changes. The FDA accepts the use of Bayesian design in medical device trials since it combines data from previous studies and the ongoing study to make changes to the study if necessary which can reduce timelines.

Clinical trial managers should also consider the following:

  • Smart Trial Design & Methodology including solutions for adaptive trial designs: adaptive design in orthopedic trials allow statisticians to make mid-course corrections, include fewer patients if possible and reduce timelines.
  • Consultancy from statisticians experienced in medical device trials for power/sample size calculations and specific analyses for orthopedic implant studies: composite endpoints, pain assessments, radiographic data and QoL measures.
  • CDISC compliant datasets: consider that the FDA will soon require CDISC-compliant datasets; meaning that statisticians need to be expert in these standards

Integrated, Cloud-based Technology

To reduce costs in orthopedic device development, an integrated eClinical platform can provide immediate feedback, more accessible trial information and higher data quality. It can facilitate an adaptive approach, or in the case of a trial that is showing a negative trend, it can allow early termination, thereby reducing the risk to patients and reducing the cost of a trial.

An integrated platform that bundles EDC/ePRO/IWRS/CTMS in the cloud provides the following benefits:

  • Sponsors can negotiate enforceable expectations for clinical data entry into the eClinical application
  • Move away from time based unit of measurements to activity-based measurements
  • Standard ad hoc reports
  • Industry and regulatory compliant archival records

CROS NT has expertise in conducting medical device trials in both the US and Europe and has represented many companies on regulatory panels. We have particular expertise in orthopedic and implant studies and have completed more than 60 studies in just the past 5 years including successful submissions in the treatment of knee pain, heel pain, THR, hip resurfacing, cartilage replacement, fusion products, artifical discs and bone growth simulators. We have also been involved in several non-inferiority trials for the lumbar and cervical spine. We have expert biostatisticians with over 25 years of experience in the medical device field with a track record of FDA panel representation for medical device submissions and proven expertise in adaptive trial design.

CROS NT joined the DATATRAK Partner Connect Program in 2013 to provide an eClinical platform with EDC/ePRO/IWRS/CTMS to reduce study costs and improve the device development process.