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
- Multigen Plus CCK (device), AMF TT cones (device)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Multigen Plus CCK — device: Total Knee Arthroplasty · AMF TT cones — device: To fill a proximal tibia or distal femur defect
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 68
- Started
- 2022-06-21
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for total knee arthroplasty
- • Clinical study - 68 participants
- • This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with total knee arthroplasty
Where?
- • Exeter - Royal Devon and Exeter Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures.
More detail
This is a post-market, multicentric, prospective, open label study. It is a post-marketing clinical study because the investigational devices are registered, CE marked, and used according to the intended use. The assignment of any subject involved in the study is determined preoperatively by the aetiology evaluated by the Investigator and falls within the current practice. The decision to use this specific prosthesis design is decided by the Investigators independently and clearly separated from the decision to include the subject in the study. Baseline measurements (pre-operative clinical assessment and radiographic analysis at discharge) serves as internal control for the assessment of post-operative data. The study will be carried out in 3 sites in Europe for a total number of 68 study subjects, in whom the decision to implant the Multigen Plus CCK system, alone or in combination with the AMF TT cones, has been taken prior to, and independently from, the decision to include the subject in the study. The enrolment is competitive until the required recruitment target is met. The expected number of visits for each study subject is 6, and includes: * a pre-operative visit (before the subject receives the Multigen Plus CCK system alone or involving the AMF TT cones). * the intra-operative visit (that is the same day of the surgery). * the discharge visit (after the surgery according to the clinical practice). * the following follow-up visits: at 3 months, 12 months, and 24 months after the surgery. All eligible subjects who agree to participate in the study will be recruited and monitored throughout the duration of the study. For each visit and for each single study subject, radiographic and clinical data will be assessed up to the 24-month follow-up visit according to the standard of care of the site, when applicable. Also, Adverse Events and Serious Adverse Events will be collected and assessed.
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
- ✓Male or female.
- ✓Age ≥ 18 years old.
- ✓Given written agreement to take part approved by the reference Ethics Committee (EC).
- ✓Subjects able to comply with the Study Protocol.
Who cannot take part
- ✗Age \< 18 years old.
- ✗Any clinically significant pathology based on the medical history that the Investigator feels may affect the study...
- ✗Female subjects who are pregnant, nursing, or planning a pregnancy.
- ✗Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \< 70...
See the full criteria
Where Is This Study? (1 UK site)
Royal Devon and Exeter Hospital
Exeter, United Kingdom
How to Get in Touch
Francesca Citossi, CIS Manager Europe & APAC
Sponsor contactCONTACT
