Early safety and performance
- Metal-ion assessment
- Imaging and RSA
- Hip function and PROMs
- Safety and device deficiencies
Orthopaedics, spine and surgical robotics · Europe
European clinical programmes for orthopaedic implants, spine devices and surgical robotics.
Eclevar brings clinical strategy, European site delivery, imaging, biometrics and medical writing into one accountable programme, from first-in-human investigation to PMCF and CER integration.
Scientific leadership
Dr Nikhil Khadabadi
Chief Medical Officer and Head of Orthopaedics and Spine
Scientific and clinical lead for Eclevar's orthopaedic, spine and surgical robotics programmes.
Device territories
Three territories, one delivery model.
Each territory has its own endpoints, centre profile and European execution constraints. Select a territory to see how a programme is built around it.
Orthopaedic implants
- Device types
- Primary and revision hip, knee and shoulder systems, bone-preserving resurfacing and cemented or cementless fixation.
- Typical clinical programme
- Pre-market clinical investigation followed by long-term post-market clinical follow-up.
- Device-specific endpoints
- Implant survivorship, revision and reintervention, radiographic assessment, and validated PROMs such as the Oxford Hip Score, KOOS and HOOS.
- European execution
- High-volume arthroplasty centres, national registry linkage and retention across multi-year follow-up.
Spine devices
- Device types
- Interbody cages, pedicle screw systems, disc replacement and complex fusion constructs.
- Typical clinical programme
- Clinical evaluation led, with prospective PMCF or a registry-based design where the evidence question allows.
- Device-specific endpoints
- Fusion status and radiographic outcomes, ODI, VAS and EQ-5D, reoperation and device-related events.
- European execution
- Spine surgery centres, standardised imaging acquisition and review, and ethics variation across markets.
Surgical robotics
- Device types
- Robotic surgical systems, navigation platforms and software-driven planning tools.
- Typical clinical programme
- Staged first-in-human introduction, controlled expansion, then PMCF and evidence following software changes.
- Device-specific endpoints
- Accuracy and alignment, functional outcomes and PROMs, procedure duration and workflow, learning curve and software version traceability.
- European execution
- Centres with system access and trained surgical teams, surgeon qualification criteria and defined training phases.
Selected orthopaedic programme · Hip resurfacing
Clinical investigation architecture for a ceramic hip resurfacing system.
JRI Orthopaedics
Ceramic hip resurfacing clinical investigation programme
Pre-market clinical investigation · In progress
Eclevar contributed to the clinical investigation strategy, synopsis and endpoint architecture, long-term follow-up planning, patient-reported outcome integration, digital data capture and statistical methodology for a two-part pre-market clinical programme.
The programme combines early safety and performance assessment with long-term evaluation of implant survivorship, hip function, imaging outcomes and revision events.
Two-part clinical investigation architecture
Long-term clinical performance
- Implant survivorship
- Revision outcomes
- Longitudinal imaging
- Registry-derived comparator methodology
- Long-term functional outcomes
Four evidence domains
Imaging follow-up
PROMs and function
Safety and revision events
Long-term survivorship
Clinical evidence supporting EU MDR clinical evaluation and PMCF
Two-part programme
Early and long-term clinical evidence
Long-term follow-up
Survivorship, imaging and functional outcomes
Integrated data
PROMs, imaging, safety and statistical methodology
Challenge, contribution and complexity
Challenge
Build a two-part clinical evidence programme addressing early safety and performance, followed by long-term implant survivorship, functional outcomes and radiographic assessment.
Eclevar contribution
- Clinical investigation strategy
- Synopsis, objectives and endpoints
- Visit, imaging and long-term follow-up architecture
- PROM and Milo ePRO integration
- Comparator and statistical methodology
- Missing-data, sensitivity and survivorship planning
Programme complexity
- Bone-preserving resurfacing with metal-ion surveillance
- Radiostereometric and radiographic precision imaging
- Follow-up horizon measured in years, not months
- Registry-derived external comparator methodology
- Patient-reported outcomes sustained across long follow-up
Milo digital evidence capture
Milo supports participant completion of the Oxford Hip Score, EQ-5D-5L and UCLA activity score within the clinical follow-up pathway.
Pre-market clinical investigation in progress. The device is developed and owned by JRI Orthopaedics. Eclevar contributed to clinical evidence architecture, follow-up planning and statistical methodology, and did not sponsor the investigation, recruit participants or conduct all study operations. Planned assessments are described as designed, not as completed. No clinical outcome, non-inferiority conclusion or regulatory decision is claimed. Participating institutions and planned cohort sizes are withheld.
Programme journey
From evidence gap to regulatory integration.
Four stages, each with a defined output and the integrated functions accountable for it. Stages can be delivered on their own or as one continuous programme.
-
Evidence strategy and feasibility
Existing data are mapped against EU MDR requirements, and candidate countries and centres are assessed against the protocol.
OutputEvidence-gap and European feasibility plan
Clinical strategyClinical operations -
Clinical investigation design
Objectives, endpoints, visit schedule and analysis are designed together so the dataset answers the regulatory question.
OutputSynopsis, protocol, endpoints and statistical architecture
Clinical strategyImagingData and biometrics -
European clinical delivery
Centres are contracted, activated and monitored by one clinical operations team, with data governed from first entry.
OutputActivated centres, monitoring and governed clinical data
Clinical operationsData and biometrics -
Evidence integration
Analysis, reporting and evidence integration are written to anticipate the questions raised during conformity assessment.
OutputAnalysis, clinical investigation reporting, PMCF outputs and CER integration
Data and biometricsMedical writingClinical strategy
Surgical robotics
Clinical evidence for surgical robotics beyond technical accuracy.
Accuracy alone does not demonstrate clinical benefit. Robotic systems need evidence that connects technical performance with patient outcomes, the surgical team and the software the system runs.
Staged clinical introduction
First-in-human planning, controlled expansion and user-training readiness.
Human factors and workflow evidence
Learning curves, use errors, workflow interruptions and system interaction.
Software-linked clinical evidence
Version traceability, algorithm changes, technical and clinical endpoints and PMCF.
Explore surgical robotics clinical programmes
The full five-domain methodology, including staged enrolment, endpoint frameworks and version traceability, sits on the surgical robotics pillar page.
European execution
European country, centre and investigator feasibility.
Each market is assessed against orthopaedic centre access, surgical volume, imaging capability, regulatory route and contracting time. Select a market to see how Eclevar delivers there.
United Kingdom
Eclevar operating entity
- Site environment
- NHS orthopaedic units with National Joint Registry-linked practice and established research infrastructure.
- Surgical-centre profile
- High-volume arthroplasty and spine units, teaching hospitals and specialist revision centres.
- Regulatory route
- MHRA clinical investigation notification, coordinated with the European evidence strategy.
Imaging, contracting and feasibility
- Imaging and technical capability
- PACS-based radiographic review, RSA capability at selected academic centres.
- Contracting considerations
- NHS model agreements and R&D capacity assessment before activation.
- Feasibility focus
- Registry linkage and retention across long implant follow-up.
Germany
In-house clinical delivery
- Site environment
- University orthopaedic clinics and certified endoprosthetics centres, with EPRD registry practice.
- Surgical-centre profile
- Endoprosthetics centres, university spine departments and robotic arthroplasty programmes.
- Regulatory route
- BfArM notification with the competent ethics committee, coordinated by the DACH team.
Imaging, contracting and feasibility
- Imaging and technical capability
- CT and radiographic protocols at academic centres; imaging standardisation agreed at feasibility.
- Contracting considerations
- Contracting lead times are the principal scheduling constraint; budgets negotiated per centre.
- Feasibility focus
- Centre selection against surgical volume and registry participation.
France
Eclevar operating entity
- Site environment
- CHU orthopaedic departments alongside high-volume private clinics.
- Surgical-centre profile
- Arthroplasty and spine surgery departments, with growing robot-assisted programmes.
- Regulatory route
- ANSM submission with CPP ethics allocation.
Imaging, contracting and feasibility
- Imaging and technical capability
- Standardised radiographic acquisition; central imaging review coordinated from France.
- Contracting considerations
- Convention unique timelines and MR-001 data-protection framework.
- Feasibility focus
- Balancing public and private centres for recruitment pace.
Spain
In-house clinical delivery
- Site environment
- High-volume public hospitals with strong recruitment performance and national arthroplasty registry participation.
- Surgical-centre profile
- Public hospital orthopaedic services and regional reference centres.
- Regulatory route
- AEMPS submission with CEIm ethics review.
Imaging, contracting and feasibility
- Imaging and technical capability
- Radiographic protocols agreed centrally; imaging capability confirmed per centre.
- Contracting considerations
- Hospital-by-hospital contracting; regional variation in lead times.
- Feasibility focus
- Recruitment strength against cost per patient.
Italy
In-house clinical delivery
- Site environment
- Orthopaedic research institutes and high-volume regional hospitals, with national arthroplasty registry practice.
- Surgical-centre profile
- Specialist orthopaedic institutes, spine units and robotic surgery centres.
- Regulatory route
- National competent authority submission with regional ethics review.
Imaging, contracting and feasibility
- Imaging and technical capability
- Imaging capability strong at institute level; protocol harmonisation agreed at feasibility.
- Contracting considerations
- Regional contracting variation is the main activation risk.
- Feasibility focus
- Sequencing activation so that lead centres open first.
Nordics
In-house clinical delivery
- Site environment
- National arthroplasty registries with near-complete capture, supporting registry-based follow-up.
- Surgical-centre profile
- National and university orthopaedic centres with long-standing registry participation.
- Regulatory route
- National competent authority and ethics routes per country.
Imaging, contracting and feasibility
- Imaging and technical capability
- Consistent radiographic practice; registry data structures support long-term outcomes.
- Contracting considerations
- Smaller centre networks; contracting is comparatively predictable.
- Feasibility focus
- Where a registry answers the question and where a sponsor-led study is required.
Coverage indicates Eclevar's operating model and delivery access. Centre availability, registry access and data-governance requirements are assessed for each programme during feasibility.
Scientific and clinical leadership
The team accountable for your orthopaedic programme.
Scientific strategy, clinical operations, programme delivery, biometrics and medical writing are led by named owners working within one integrated programme team.
Scientific and clinical lead
Dr Nikhil Khadabadi
Chief Medical Officer and Head of Orthopaedics and Spine
Dr Khadabadi leads clinical strategy, endpoint architecture and scientific decision-making across Eclevar's orthopaedic, spine and surgical robotics programmes. His role connects the surgical context of the device with the clinical and regulatory evidence required across its lifecycle.
Programme accountability
- Clinical evidence strategy
- Clinical investigation design
- Endpoint and follow-up architecture
- Surgical and imaging relevance
- Scientific oversight
- CER and PMCF evidence integration
Selected programme involvementScientific leadership for the ceramic hip resurfacing clinical investigation programme.
Nikhil on LinkedInThe delivery team
Susanne Höfer
Head of Clinical Operations, DACH region
Accountable for feasibility, centre selection, activation, monitoring and DACH clinical delivery.
Leads the DACH operational route
Susanne on LinkedIn
Charline Petitdemange
Project Delivery Lead, France and United Kingdom
Accountable for European programme mobilisation, delivery, governance and close-out.
Delivery lead on European multicentre programmes
Charline on LinkedIn
Sébastien Meier Piantanida
Head of Data Management and Biostatistics
Accountable for biometrics, EDC, statistical methodology, data governance and inspection readiness.
Statistical methodology on the selected hip resurfacing programme
Sébastien on LinkedIn
Pierre-Marie Boutanquoi
Head of Medical Writing
Accountable for clinical investigation reporting, PMCF outputs, CER integration and responses to clinical evidence questions.
CER and PMCF integration across implant programmes
Pierre-Marie on LinkedInOne accountable programme team
- NikhilScientific and clinical strategy
- SusanneClinical operations
- CharlineProgramme delivery
- SébastienData and biometrics
- Pierre-MarieMedical writing and regulatory evidence
Applicable regulatory and quality frameworks
Regulation (EU) 2017/745
ISO 14155:2026
ISO 13485
GDPR
21 CFR Part 11
Programmes delivered in accordance with applicable requirements under Regulation (EU) 2017/745 and ISO 14155:2026.
Resources and FAQ
Clinical evidence and insights.
Published whitepaper
Read the whitepaper
EU MDR post-market clinical follow-up, written with BSI.
A practical reading of clinical evidence expectations under Regulation (EU) 2017/745, written with the Notified Body BSI.
Broader study-delivery capability: Eclevar manages RegenLab's randomised PMCF programme on chronic wound devices across five EU countries, evidence of European study delivery rather than orthopaedic expertise.
Questions orthopaedic, spine and surgical robotics sponsors ask.
When does an orthopaedic implant require a clinical investigation?
Class III and implantable devices generally require clinical investigations under Article 61 of Regulation (EU) 2017/745, unless a specific exemption such as demonstrated equivalence applies. The decision depends on the device, its claims and the existing clinical evidence, which is why programmes start with an evidence-gap analysis.
How should PMCF be designed for Class IIb and Class III implants?
Proportionately to the device risk and the residual evidence questions. For implants this usually combines validated PROMs, imaging review where indicated, and follow-up horizons that reflect implant survivorship, using surveys, observational studies or registry-based designs aligned with MDCG 2020-7.
What evidence is needed for a robotic surgical system beyond accuracy?
Accuracy is a technical performance measure, not a clinical benefit. Robotic systems usually also need evidence on patient outcomes, workflow effects, training and learning curves, human factors and behaviour across software versions, selected according to the system's claims and risk profile.
How are software versions controlled during a clinical investigation?
Each procedure is linked to the software and algorithm version in use, and version changes are documented and assessed for their impact on the investigation. This keeps the dataset interpretable and supports evidence arguments when the system evolves after the study.
When is a registry sufficient and when is a sponsor-led study required?
A registry can be sufficient when its population, data quality and follow-up answer the specific evidence question. A sponsor-led study is usually needed when endpoints, imaging, comparators or data completeness go beyond what the registry captures. The decision is made in the evidence-gap analysis.
How does Eclevar select European orthopaedic centres and investigators?
Feasibility assesses surgical volume in the relevant procedure, imaging capability, research infrastructure and, for robotics studies, access to and experience with the system under investigation. Centres are proposed with a documented rationale before activation.
Related pages
Adjacent capabilities, on their own pages
Imaging core lab and RSA
Radiostereometric analysis and centralised imaging review for arthroplasty programmes.
Clinical evaluation report
CER writing and updates for implantable devices under EU MDR.
PMCF programmes
Post-market clinical follow-up plans, studies and evaluation reports.
Feasibility and site selection
Country, centre and investigator selection before the protocol is fixed.
Start the conversation
Planning an orthopaedic, spine or surgical robotics programme in Europe?
Share your device type, development stage and target markets. Eclevar's clinical team will identify the principal clinical, operational, data and regulatory workstreams for an initial discussion.
Discuss your orthopaedic or spine programme
Tell us the device type, the indication, your development or certification stage and the evidence question you need answered.