Therapeutic Areas: Orthopedics & Spine

Engineering a Future Without Limits

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.

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.

See how Proxima's strategy can guide your trial

Orthopedics & Spine Experience

Support from start to finish. Proxima designs your trial endpoints to address the most pressing questions about your device's benefits early on.

Today’s regulatory requirements have placed more responsibility on sponsors to demonstrate clinical benefit through the safety and effectiveness results obtained from clinical trials.

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.

Orthopedics Experience:

Hip Repair and Replacement

Shoulder Repair

Knee Repair and Replacement

Osteoarthritis

Peripheral Joint Repair

Spine Experience

Trauma

Spine Experience:

Scoliosis

Compression Fracture

Spinal Fusion

Spinal Stenosis

Degenerative Disc Disease

Endpoint Experience:

Fusion Rates and Quality
‍(EQ-5D, SF-12, SF-36, VAS, HHS, KOOS, WOMAC)

Endpoint Adjudication Committees

HRQOL

Health Economics

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)

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

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Position

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Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium that includes Baylor College of Medicine, Texas Children's Hospital, Texas A&M University, Rice University, University of Houston, and Fannin Innovation Studio. SWPDC is supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.