Orthopedics & Spine

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.

PRODUCT
EXPERIENCE

ENDPOINT
EXPERIENCE

PRODUCT EXPERIENCE

Support from start to finish

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.

Orthopedic:

Hip Repair and Replacement
Knee Repair and Replacement
Ankle Fusion Devices
Shoulder Repair
Osteoarthritis
Peripheral Joint Repair
Spine Experience
Trauma

Spine:

Scoliosis
Spinal Fusion
Degenerative Disc Disease
Compression Fracture
Spinal Stenosis

ENDPOINT EXPERIENCE

Our team is experienced with:

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)

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.

Supporting your orthopedic and spine development