woman stretching for a workout
purple background
Therapeutic Areas Musculoskeletal & Orthopedics

Musculoskeletal & Orthopedics

Innovation in musculoskeletal and orthopedic medicine demands precision, from complex surgical procedures and imaging-driven endpoints to long follow-up periods that test the durability of devices over time. Avania understands these challenges because this is where our experience runs deepest.

Our MedTech-focused model equips sponsors with strategies that anticipate the unique complexities of orthopedic development: variable surgical techniques, composite imaging requirements, and increasingly stringent post-market evidence expectations under EU MDR. We help ensure studies are designed not just to meet regulatory standards, but to strengthen clinical and commercial outcomes.

chiropractic neck adjustment

Advancing Musculoskeletal & Orthopedic MedTech

With access to an integrated network of investigators, imaging specialists, and regulatory experts, Avania reduces risk and accelerates progress, supporting both new technologies entering the market and established products seeking to expand indications or market share.

Orthopedic surgeon smiles encouragingly while discussing x-ray with patient

Navigating the Unique Challenges of

Orthopedic Device Development

Every orthopedic program is different, yet all share the same demand for precision, consistency, and clinical rigor. Whether the focus is reconstructive surgery, spinal stabilization, joint repair, or orthobiologic innovation, Avania helps sponsors manage the variables that define success.

Our teams blend deep regulatory insight with practical operational expertise, balancing the need for robust clinical evidence with the market’s growing demand for real-world validation. We understand that the same implant may perform differently by surgeon, site, or patient population; we plan accordingly, integrating surgeon training, imaging oversight, and pragmatic follow-up methods that ensure reliable data.

Because Avania was built for MedTech, we bring an understanding of orthopedic device classifications, PMA and IDE study requirements, and global submission expectations that generalist or pharma-first CROs simply can’t match.

Unparalleled Expertise:

Meet Our Musculoskeletal & Orthopedic MedTech Veterans

The Avania Team Advantage

Orthopedic innovation requires collaboration among engineers, clinicians, and scientists who truly understand the anatomy of both the body and the business. Avania’s musculoskeletal and orthopedic teams are led by industry veterans and supported by an expanding network of subject matter experts who engage directly with sponsors and study sites.

Our clients value this access: not to faceless project teams, but to proven professionals who guide strategy, address challenges in real time, and deliver consistently across programs and geographies.

Pharmaceutical sales representative talking with doctor in clinic lobby. Ambitious male sales representative presenting new medication

Deep Therapeutic & Industry Insight

Our team members have spent their careers advancing orthopedic science. Many come from within the industry itself, experienced in device development, spine research, and clinical program leadership. Their prior roles within leading MedTech organizations give them invaluable perspective in anticipating regulatory hurdles and practical study constraints.

business people in office boardroom

Consistent, Dedicated & Flexible Teams

Continuity is one of Avania’s hallmarks. Our clients often work with the same project leaders throughout a study’s duration, ensuring efficiency and trust. This stability, coupled with responsive communication and adaptive planning, allows us to function as an extension of each sponsor’s internal team.

Avania’s specialists — from project managers to orthopedic surgeons — remain deeply engaged throughout each study, offering flexibility and foresight that large, process-bound CROs can’t provide.

Diverse Team Collaborating

Integrated Solutions for Musculoskeletal & Orthopedic Innovation

Avania delivers comprehensive, multidisciplinary support across the entire musculoskeletal product lifecycle, aligning regulatory, clinical, and commercial considerations from the outset.

Strategic Consulting & Regulatory Pathways

Our regulatory experts have extensive experience with OHT6 (the FDA’s Office of Orthopedic Devices) and comparable authorities worldwide. We guide sponsors through IDE and PMA strategies, MDR submissions, and ongoing post-market requirements, ensuring each program meets the technical and evidence expectations of global regulators and payors.

From adaptive study designs and composite endpoints to reimbursement-aligned protocols, Avania helps clients streamline development while safeguarding data quality.

Clinical Development & Execution

Avania designs and executes orthopedic trials across every phase: from early feasibility to global pivotal and post-market studies. Our operational teams coordinate every detail: site management, monitoring, imaging, data management, and safety oversight.

Right-sized systems like eConsent and ePRO streamline participation and compliance, while our registry design expertise supports long-term data collection and post-approval studies that meet both regulatory and market needs.

Our Track Record

Demonstrated Success in Orthopedics

Avania’s orthopedic and musculoskeletal portfolio reflects decades of experience across spine, joint, biologic, and sports medicine technologies. We have delivered more than 160 orthopedic and spine-related projects worldwide, spanning limited-scope engagements to full-service global programs.

Our reach includes 40+ global sites and 150+ surgeon relationships across North America, Europe, Latin America, and Asia-Pacific, supported by scalable operational infrastructure that adapts from single-site feasibility to multi-country pivotal trials.

  • Vertebral augmentation treatment for spinal fractures
  • Intervertebral body fusion procedures
  • Posterior pedicle screw fixation system spinal procedures
  • Degenerative disc and joint disease
  • Spinal stabilization and surgical procedures
  • Vertebral disc replacement for degenerative disc disease
  • Lumbar spinal stenosis
  • Anterior cruciate ligament repair/reconstruction/replacement
  • Shoulder arthroplasty
  • Partial joint and total joint replacement
  • Prosthetic devices
  • Artificial meniscus
  • Avascular necrosis treatment (hip)
  • Cartilage replacement
  • Subchondroplasty procedures
  • Regenerative or biologic repair of cartilage
  • Viscosupplementation (many studies)
  • Supported >100 studies with pain scales as primary or secondary endpoints (i.e. VAS, NRS)
  • Statistical team adept at analyzing patient reported outcomes for regulatory approval and publication
  • Active partnerships with KOLs and physicians in pain management for safety board or steering committee membership
  • Electrical nerve stimulators
  • Treatment of tendinopathy
  • Musculoskeletal and connective tissue disorders
  • Stem-cell-derived bone formation
  • Reattachment of soft tissue to bone
  • High tibial osteotomy
  • Hammertoe deformity implants and surgical procedures
  • Osteosynthesis of long bones
  • Bone stabilization system treatment for bone fractures
  • Sacroiliac joint fixation products
  • Stabilization devices for hyperpronated foot and subtalar joint
  • Bone void fillers
  • Fracture healing with HA and growth factors
  • Treatment of pseudoarthrosis
colleagues laughing and sharing ideas

Client

Successes

These successes underscore Avania’s ability to deliver complex studies with precision, foresight, and partnership, ensuring every milestone brings our clients closer to market impact.

“Avania has been a trusted partner to us for many years. Their deep understanding of the medical device and orthopedic landscape, combined with their ability to deliver across global regulatory, clinical, and data functions, has been instrumental to our success. What truly sets them apart is their flexibility: they adapt quickly to our evolving needs without compromising quality or timelines. With clear, transparent and frequent communication, Avania operates as an extension of our team, always aligned with our goals and committed to our outcomes. They’re a strategic partner and problem solver we rely on.”

Tanner Howe
CEO, AgNovos Bioscience
agnovos logo

Case Study

Streamlining Global Bone Disease Programs Through Flexible Partnership with AgNovos Bioscience

Company:

A medical technology company pioneering novel treatments for bone disease

Solution:

Avania presented a comprehensive programmatic solution to consolidate the outsourced clinical activity, while providing the flexibility to partner with AgNovos on several activities to best utilize the sponsor’s strong internal team

Problem:

AgNovos had several programs running in parallel throughout the globe across multiple use cases, with a hybrid executional strategy utilizing several CRO partners alongside a strong internal clinical development team

Outcome:

Avania and AgNovos worked through an efficient transition of activity to drive efficiencies in cost and study execution. The flexible model of service has been helpful in predicting cash flow for AgNovos as well

Case Study

Expanding ACL Implant Indications With Real-World Evidence

Device:

Anterior cruciate ligament (ACL) implant

Solution:

Avania supported the opening of a US registry intended to be low burden on the site and patients (i.e. following real-world performance); Avania combined registry data with prior pre and post market study data to expand on label indication for age

Problem:

Following the FDA De Novo 510(k) approval, the sponsor sought to collect real-world evidence on the implant to be used for potential post market label expansion

Outcome:

FDA 510(k) approval to expand its indication to include children and adolescents of any age, as well as to treat partial ACL tears

Case Study

Advancing Cartilage Implant Trials Through Integrated Data Systems

Device:

Synthetic cartilage implant for chondral and osteochondral knee lesions

Solution:

Robust and well designed EDC System with Imaging and ePRO capabilities

Problem:

Imaging and subject questionnaire collection required at multiple intervals

Outcome:

Pilot study expanded into Pivotal Global Study, with seamless coordination between Data Management, Core Lab, and Sites

Case Study

Enabling Phase II Success for Spinal Fusion Combination Therapy

Drug:

Combination drug/device for treatment of degenerative disk disease

Solution:

Avania supported a Phase II randomized trial intended to provide initial safety/efficacy data, find the appropriate dose, and determine the pharmacokinetic profile of the study product

Problem:

The sponsor sought to investigate the drug for its use in achieving spinal fusion prior to a potential Phase III trial and eventual NDA application

Outcome:

Study fully enrolled throughout pandemic, providing the sponsor with required outcome data necessary to proceed with the pivotal program

Partner with Avania’s

Musculoskeletal and Orthopedic Experts Today

Orthopedic innovation doesn’t pause for complexity, and neither do we. From early strategy to market expansion, Avania provides the integrated expertise, steady partnership, and global reach that transform promising technologies into proven solutions.

Connect with Our Experts