NCT00698854Completed
A Clinical Investigation of the Vanguard™ Complete Knee System
A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 552 (actual)
- First submitted
- 13 Jun 2008
- Start date
- Mar 2004
- Primary completion date
- Jan 2021
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT00698854
What you commit to
- Study type: Observational
- Participants enrolled: 552
- From Mar 2004 to the primary completion date, Jan 2021
- 8 sites 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Failure of a previous joint replacement
- Relative contraindications include:
- Incomplete or deficient soft tissue surrounding the knee
- Additional exclusion criteria includes: failure of a previous joint replacement
Other illness
- Infection
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Metabolic disorders which may impair bone formation
- Distant foci of infections which may spread to the implant site
- Vascular insufficiency, Muscular atrophy, Neuromuscular disease
Other
- Absolute contraindications include:
- Sepsis
- Osteomyelitis
- Osteoporosis
- Osteomalacia
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Who the study is looking for
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity
- Correction or revision of unsuccessful osteotomy, or arthrodesis
- Patient selection factors to be considered include:
- Need to obtain pain relief and improve function
- Ability and willingness of the patient to follow instructions
- Including control of weight and activity level
- Good nutritional state of the patient
- Patient must have reached full skeletal maturity
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Orthopedic Specialists Coordinator of this site? Confirm its status | Cape Girardeau | United States | Unknown status |
| Physicians Clinic of Iowa Orthopedics Coordinator of this site? Confirm its status | Cedar Rapids | United States | Unknown status |
| Orthopedic Associates Coordinator of this site? Confirm its status | Fishersville | United States | Unknown status |
| Texas Orthopedic Specialists Coordinator of this site? Confirm its status | Grapevine | United States | Unknown status |
| Othopaedic & Sports Medicine Clinic of Monroe Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| Orthopaedic Associates of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| The Orthopaedic Center Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Spokane Orthopedics Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.