Status:
COMPLETED
Vanguard™ Deep Dish Rotating Platform Knee Clinical Evaluation
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is being conducted on the Vanguard™ Deep Dish Rotating Platform (DD RP) to evaluate the clinical efficacy of the DDRP components.
Detailed Description
This study is designed to evaluate the safety and efficacy of Vanguard™ Deep Dish Rotating Platform Knee (mobile bearing knee) as compared to Vanguard Cruciate Retaining Knee (fixed bearing knee). Thi...
Eligibility Criteria
Inclusion
- Patients with a pre-operative Knee Society Score of \< 70
- Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are involved
- 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
Exclusion
- Absolute contraindications include the following diagnoses:
- Patients with a pre-operative Knee Society Score of \>= 70
- Infection
- Osteomyelitis
- Previous partial or total prosthetic knee replacement on the operative side
- Patients who are less than 18 years of age
- Sepsis
- Patients who had body mass index \>= 40
- Relative contraindications include the following factors:
- Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis
- 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, or neuromuscular disease in the affected limb.
- Incomplete or deficient soft tissue surrounding the knee
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00753090
Start Date
June 1 2009
End Date
July 15 2022
Last Update
January 30 2025
Active Locations (4)
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1
CHU Lyon Sud
Pierre-Bénite, France, 69310
2
Bravis Ziekenhuis
Roosendaal, Netherlands
3
Zuyderland Medisch Centrum Sittard-Geleen
Sittard, Netherlands
4
The Hillingdon Hospital NHS Trust
Middlesex, United Kingdom