Status:
COMPLETED
Signature Versus Computer Assisted Surgery Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Joint Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.
Detailed Description
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery....
Eligibility Criteria
Inclusion
- Inclusion criteria are identical to the indications for use stated in the FDA cleared labeling for the device (510(k) K023546, K033489, and K050222).
- These indications are stated below:
- 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, arthrodesis, or failure of previous joint replacement procedure.
- The Regenerex™ femoral augments are indicated for use with the Vanguard® Total Knee System.
- The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
- 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
- A good nutritional state of the patient, and
- The patient must have reached full skeletal maturity
- Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok™) devices and all polyethylene patellar components are indicated for cemented application only.
Exclusion
- Exclusion criteria are identical to the contraindications stated in the FDA cleared labeling for the device 510(k) K023546, K033489, and K050222. These contraindications are stated below:
- Absolute contraindications include: infection, sepsis, and osteomyelitis
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders who is 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.
- Biomet® Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01256216
Start Date
September 1 2010
End Date
May 1 2016
Last Update
June 19 2017
Active Locations (1)
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1
Russells Hall Hospital
Dudley, United Kingdom