At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pheno4U (device)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- Pheno4U — device: Total Knee Arthroplasty represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or other indications resulting in joint destruction.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a data platform called PHENO4U in people having a total knee replacement (an operation to replace the knee joint with an implant). It includes people with knee problems such as osteoarthritis, rheumatoid arthritis, injuries, instability, stiffness or deformity. The sponsor is Aesculap AG.
Who can take part
- Having a total knee replacement with a B. Braun knee implant
- Giving written informed consent
- Being willing and able to use the 'BPMpathway' sensor
- Being willing and able to use the '4Patient' app
Who may not be able to
- Being under 18 years old
- Not being willing to take part in further follow-up
- Being pregnant
- Having an implant from a different maker used during the operation
What taking part involves
- • Using the 'BPMpathway' sensor
- • Using the '4Patient' app
- • Follow-up as part of the study
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2022-09-28
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for degenerative osteoarthritis
- • Clinical study - 600 participants
- • Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with degenerative osteoarthritis
Where?
- • Nottingham - Nottingham University Hospital NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
More detail
The study will collect data for each patient receiving an Aesculap Total Knee Arthroplasty (TKA) implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies. The products under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). Data obtained in routine clinical use will be collected in the Pheno4U data platform. In addition, patients are expected to answer questionnaires about their health status. Furthermore, patients are asked to use the so called "BPMpathway" sensor and application in order to measure the active Range of Motion (ROM). The sensor can also be used for pre- and postoperative training .
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patient undergoing a total knee arthroplasty with a B. Braun knee implant system
- ✓Signed written agreement to take part
- ✓Patient's willingness \& ability to use the "BPMpathway"sensor
- ✓Patient's willingness \& ability to use the "4Patient" application
Who cannot take part
- ✗Patient age \< 18 years
- ✗Patient not willing to participate at the further follow-up
- ✗Pregnancy
- ✗If intraoperatively an implant from a different manufacturer is used, the study patient has to be excluded from the...
See the full criteria
Where Is This Study? (1 UK site)
Nottingham University Hospital NHS Trust
Nottingham NG7 2UH, United Kingdom
How to Get in Touch
Stefan Maenz
Sponsor contactCONTACT