Claims, joint-specific outcomes, imaging, PROMs, survivorship, PMCF and the CER need to align before the protocol is finalized. Eclevar MedTech supports hip, knee, shoulder, elbow, ankle and revision systems, from evidence strategy and first-in-human studies through imaging and RSA planning, PMCF, registries and clinical evaluation.
CMO · Orthopedics & Spine
NHS orthopedic surgeon
in orthopedic surgery & Class III implant evidence
Chief Operating Officer · former TÜV SÜD Senior Reviewer · Senior Consultant Surgeon
in device evaluation & Notified Body review
Chief Data Officer · Biometrics & Data Systems
in clinical data management, EDC & biometrics
Each has a clear entry point. The first step should not automatically be a new study, but a structured review of what the current evidence supports and what remains uncertain.
Early concept or design freeze, with the evidence pathway still open.
Clinical evaluation challenged on claim support, equivalence or residual risk.
A draft protocol whose endpoints, timepoints or success criteria need checking.
Deficiency letters or meeting notes that need a defensible evidence answer.
Residual uncertainty in the CER that needs a proportionate post-market model.
Short-term sponsor data that must grow into survivorship evidence.
A paid, defined engagement. Scope, timeline, fee and required documents are agreed in a written proposal before work begins.
Before the protocol is written we map the claims against the study types that can actually answer them. What the map leaves empty is what the program still has to cover.
Arthroplasty evidence becomes difficult to defend when each study is designed in isolation. The conclusion required in the CER should influence endpoint selection at the beginning.
No single study should be expected to answer every short-term, radiographic, functional and long-term question.
Country selection drives arthroplasty center volume, registry access, RSA capability, imaging readiness, follow-up reliability, contracting timelines and cost per patient.
Registry access and data governance vary by country and are assessed individually during feasibility.
Each joint has different failure modes, outcome conventions and follow-up priorities.
Fixation, stability, wear, dislocation and periprosthetic fracture. HHS or HOOS with radiographic assessment, revision and survivorship.
Pain relief, function, satisfaction, alignment, instability and wear. OKS or KOOS with range of motion, imaging and revision; responder analysis adds what mean scores hide.
Anatomic and reverse systems need different logic: fixation, instability, glenoid loosening, notching, cuff function. Constant-Murley or ASES with defined radiographs.
Smaller populations and a less mature evidence base. Multicenter studies, specialist networks, registries and retrospective RWE are often decisive.
Heterogeneous indications, compromised bone stock, limited comparators. Re-revision and bone-loss management analyzed in meaningful strata.
Hip, knee, shoulder, small joints and revision do not share one endpoint set. The illustration below maps the dominant failure modes to the instruments that are normally used to measure them.
Each study type answers a different class of question. The program should combine only what the device, its claims and the remaining uncertainties require.
Early safety, feasibility and initial performance, with careful site and surgeon selection.
Confirmatory performance and safety against prespecified endpoints under ISO 14155.
Standardized radiographic assessment and implant-migration measurement where fixation is central.
Proportionate post-market designs matched to residual uncertainty in the CER.
Long-term survivorship and lower-frequency outcomes, with caution on case mix and coding.
Prespecified revision definitions, competing-risk methods and sensitivity analyses.
Fixation and migration belong to the bone-implant interface, wear to the bearing, stability to the construct. Reading the claim back to the component keeps the endpoint set honest.
The first question is not which score to use, but what the device is intended to claim.
Worked example. A claim of improved knee function at two years needs a prespecified functional endpoint, an instrument such as OKS or KOOS, a two-year assessment, a justified responder definition and an analysis plan addressing missing data. The CER should then conclude on that same claim.
The same traceability applies to safety endpoints, radiographic outcomes and composite criteria. Our biostatistics team prespecifies these choices in the SAP.
From site radiographs and CT to core lab reads, pseudonymization and endpoint adjudication, we keep a single controlled pipeline so the same clinical event never exists in three inconsistent forms.
A radiographic strategy defines how images are acquired, transferred, reviewed and linked to the clinical database: component position, radiolucent lines, osteolysis, loosening, alignment or notching. A charter agreed before first enrollment reduces variation between sites and makes pooled analysis more reliable.
Radiostereometric analysis gives highly precise measurement of implant migration and micromotion. It is valuable when early fixation is a central question: cementless designs, new coatings or modified geometries. RSA requires specialist centers, equipment and protocol provisions, so feasibility must be assessed during study design.
Survivorship is central to arthroplasty evidence. A defensible analysis should consider:
Survivorship is central to arthroplasty evidence, and the number depends on what counts as an event. The definitions are fixed in the statistical analysis plan, before database lock.
PMCF is not one study type. The appropriate model depends on residual uncertainty in the CER, the risk management file and post-market data.
A structured HCP or patient survey can suit lower-volume devices, small-joint systems, instrumentation, handling and routine-use performance. Survey evidence may be insufficient where the principal uncertainty relates to fixation, migration, wear, radiographic progression, revision or long-term survivorship.
Feasibility, contracting, activation, monitoring and close-out across European specialist centers, with one team accountable for the evidence from protocol to CER.
Every study should be designed with its downstream regulatory use in mind. Before first enrollment, we map how the planned outputs flow through the technical documentation.
CRO deliverables become disconnected when the study report, CER, PMCF documents and claims are developed by separate teams. Eclevar MedTech brings clinical strategy, operations, data, statistics and clinical evaluation into the same program so endpoints, analyses and conclusions remain traceable.
Timelines follow evidence maturity, protocol readiness, imaging or RSA requirements, country selection and specialist-center availability. Costs follow countries and sites, monitoring model, imaging frequency, core lab or RSA scope, follow-up duration and the extent of CER and PMCF writing. We quote in defined work packages.
Related Eclevar pages across the orthopedic program.
It depends on intended purpose and claims, device novelty, available data, the strength of any equivalence argument, residual risks and Notified Body feedback. The Arthroplasty Evidence Assessment maps these before a protocol is commissioned.
Yes, where the registry population, variables, follow-up, device traceability and data quality are relevant to the residual uncertainty. It works best alongside sponsor-controlled clinical, imaging or PROM data.
When early migration or fixation is a central question, especially for a new cementless design, coating or geometry. Feasibility depends on specialist centers, the comparator and the planned clinical interpretation.
The instrument should follow the claim, joint, population and timepoint. HHS, HOOS, OKS, KOOS, Constant-Murley and ASES are common, but the choice and responder definition must be justified for the specific study.
Yes. The Protocol and Endpoint Review examines claim alignment, endpoint hierarchy, timepoints, imaging, success criteria, missing-data assumptions and downstream CER use.
Yes. A dedicated DACH arthroplasty page covers country pathways, specialist-center strategy and operational delivery.
Yes. Each engagement can stand alone: evidence assessment, protocol review, imaging strategy, PMCF design or CER remediation.
Send us your device description, intended claims, existing clinical data and any Notified Body correspondence. You receive an evidence gap map, a claim-to-evidence matrix and a proportionate pathway.
Your documents are reviewed confidentially. An NDA can be put in place before we receive technical or clinical information.
