NCT04076202Active, not recruiting
Clinical Evaluation of Vanguard DD RP
Clinical Evaluation of Vanguard Deep Dish Rotating Platform Knee - Cementless Fixation With Finned Stem
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an Austrian patient population
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 113 (actual)
- First submitted
- 23 Aug 2019
- Start date
- 11 Jul 2013
- Primary completion date
- 26 Aug 2018
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04076202
What you commit to
- Study type: Interventional
- Participants enrolled: 113
- From 11 Jul 2013 to the primary completion date, 26 Aug 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absolute contraindications include the following diagnoses:
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Skeletal immaturity of the patient
- Sepsis
- Patients who are less than 18 years of age
Other illness
- Relative contraindications include:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
- osteomalacia,
- distant foci of infections which may spread to the implant site,
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
- vascular insufficiency, muscular atrophy, neuromuscular disease,
- incomplete or deficient soft tissue surrounding the knee
Who the study is looking for
- Patients scheduled to undergo primary total knee replacement:
- with painful and disabled knee joint resulting from any of the following diagnoses:
- Osteoarthritis,
- Traumatic arthritis,
- Rheumatoid arthritis with one or more compartments involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy or arthrodesis.
- Need to obtain pain relief and improve function.
- Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
- A good nutritional state of the patient.
- Full skeletal maturity of the patient, patients who are at least 18 years of age.
- Patients of either sex.
- Consent form read, understood, and signed by patient.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kepler Universitäts Klinikum Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.