Active, not recruiting OBSERVATIONAL NCT06089291

A knee replacement with built-in sensors recording gait after surgery — implants appear in 11 of the 803 trials this site holds as of 2026-08-31 (Zimmer Biomet, NCT06089291)

Zimmer Biomet Updated 2026-06-04

A prospective multicenter longitudinal cohort study of Persona IQ, a knee replacement with built-in sensors. Kinematic gait metrics captured through remote therapeutic monitoring are used to develop correlative measures helping surgeons understand and manage recovery. Planned enrollment is 200.

Trial overview (primary data)

  • StatusActive, not recruiting
  • ConditionsOsteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty, Total Knee Replacement
  • InterventionsDEVICE: Persona IQ
  • SponsorZimmer Biomet
  • Target enrollment200 participants
  • Period2024-02-20 〜 2026-12-01

Key points

  • A prospective multicenter longitudinal cohort study of Persona IQ, a knee replacement with built-in sensors. Planned enrollment is 200.
  • Kinematic gait metrics are captured through remote therapeutic monitoring using CANARY sensors together with the mymobility app.
  • The primary objective is developing correlative measures that assist surgeons in understanding and managing recovery through post-operative gait metrics.
  • The secondary objective evaluates remote therapeutic monitoring and healthcare utilization; exploratory aims name future product feature development and data algorithm products.
  • Of the 803 trials this site holds as of 2026-08-31, 11 have bodies touching implants, against 22 touching wearables.
  • Sensor values alone say nothing about recovery; the main objective is building correlative measures of what those values indicate.

1What is implanted keeps measuring

Once a joint replacement is in, its condition has ordinarily only been checkable through imaging or examination. This product carries built-in sensors and records how the patient walks continuously. Not only on the day of a visit but through everyday movement, data remains for the whole period after surgery, opening the possibility of knowing whether recovery is on track without waiting for the next appointment.

Of the 803 medical-AI clinical trials this site holds as of 2026-08-31, 11 have bodies touching implants — fewer still than the 22 touching wearables.

2Framing the objective as building correlative measures

The wording of the primary objective is distinctive. It is not to evaluate gait metrics themselves but to develop correlative measures assisting surgeons in understanding and managing recovery. What a sensor produces is a number for steps or manner of walking, and that alone does not mean recovery is going well or badly.

Which values, at which levels, indicate progress and which call for attention — building that correspondence is the objective. Between data being collectable and data being usable for judgment, this step sits.

3Product development written into the exploratory aims

The exploratory objective names analyses directing future product feature development and data algorithm products. Data gathered in clinical research is thereby also positioned as material for building the next product. That phrasing is unremarkable in industry-sponsored trials, but its appearance as a stated objective is a fact readable from the record. What measures the study actually produced is not part of this registry record.

4Being measurable, and being usable in a judgement

What the sensor produces is a number for step count or gait, which by itself says nothing about whether recovery is going well. The study's main objective sits exactly in that gap.

  1. 1The sensor recordsGait is captured continuously as data
  2. 2Numbers accumulateEveryday movement is recorded throughout the period after surgery, not only on visit days
  3. 3Build correlative measuresEstablish which values, at what level, indicate good progress and which call for attention
  4. 4Use it in a judgementHelp the surgeon understand and manage recovery

A joint replacement has ordinarily been assessable only through imaging or examination after implantation. Between data being available and data being usable in a judgement sits the work of building correlative measures. Exploratory objectives also include analysis to inform future product features and data algorithm products.

Why it matters

Data being collectable continuously and data being usable in clinical judgment are different things. That this study makes developing correlative measures its primary objective shows the step needed to bridge them. Continuous data from a medical device arrives in volume, but without meaning attached it goes unused on the floor.

FAQ

What is a knee replacement with sensors?
Per the record, a system combining the Persona Personalized Knee with an app platform, where implanted sensors record kinematic gait metrics continuously.
What does developing correlative measures mean?
The numbers a sensor produces do not themselves indicate good or poor recovery. Building the correspondence between values and progress is stated as the primary objective.
What were the results?
The measures the study produced are not part of this registry record.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Clinical trials#AI#Healthcare#Orthopaedics#Remote monitoring
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