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Orthopedic trials have unique challenges, including design issues, sham controls, sample size, and the need for patient-centered outcomes.
As a sponsor, you need a fast, efficient, and focused approach for your orthopedic or spine medical device journey. Rest assured you’re in good hands when you choose Proxima as your development partner.
Today’s regulatory requirements have placed more responsibility on sponsors to demonstrate clinical benefit through the safety and effectiveness results obtained from clinical trials. This means it’s imperative that you design your trial endpoints to address the most pressing questions about the benefit of your device early on. With Proxima, you’ll have a leg up. Our team of experts will help you design trials that deliver the results you need, while also providing valuable insight across a wide range of modalities that require clinical trial and payor and provider evaluations.
Our clinical and regulatory management strategy focuses on agility, efficiency, speed, and a deep understanding of the orthopedic and spine space. Whether your trial is in support of a PMA, 510(k), or post market surveillance, we understand the challenges of conducting successful medical device trials, so we’ll work on a plan that considers all of your needs and exceeds your expectations.
At Proxima, we are ready to tap into our wide range of orthopedic and spine product experience to support you on your clinical journey.
Fusion Rates and Quality (EQ-5D, SF-12, SF-36, VAS, HHS, KOOS, WOMAC)
HRQOL
Health Economics
Endpoint Adjudication Committees
RCT (Power Calculations, Randomization Ratio, Blinding, Cohort Arms, Choice of Control Procedure, and Rate of Crossover, Dropout, and Missing Data)
Outcome Measures (Time Points, Primary Composite Endpoint, Secondary Endpoints, Surrogate Radiographic Endpoints, Choice of Clinical Instruments, and Time of Final Follow-Up)
Time Points, Primary Composite Endpoint, Secondary Endpoints, Surrogate Radiographic Endpoints, Choice of Clinical Instruments, and Time of Final Follow-Up.
