Status:
ACTIVE_NOT_RECRUITING
Clinical Evaluation of Vanguard DD RP
Lead Sponsor:
Zimmer Biomet
Conditions:
Knee Osteoarthritis
Post-traumatic Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 evaluat...
Detailed Description
This is a single cohort, prospective study of performance and safety of the Vanguard Deep Dish Rotating Platform (DD RP) - cementless fixation with finned stem. The performance will be assessed by Oxf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT04076202
Start Date
July 11 2013
End Date
December 31 2026
Last Update
May 17 2024
Active Locations (1)
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1
Kepler Universitäts Klinikum
Linz, Austria, 4021