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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01308515
Other study ID # 090809
Secondary ID
Status Withdrawn
Phase N/A
First received June 2, 2010
Last updated June 19, 2017
Start date September 2010
Est. completion date September 2010

Study information

Verified date June 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria are identical to the indications stated in the FDA approved 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, 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

- A good nutritional state of the patient

- The patient must have reached full skeletal maturity

Exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222.

These contraindications are stated below:

-Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vanguard Knee System with AS Bearing
FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.
Vanguard Knee System with PS Bearing
FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Knee Score Average objective knee score; includes a combination of range of motion and pain scores. 1 Year Post-op
Secondary Knee Society Score Average total knee score. Includes the objective and functional aspects of the knee score. 3 Years
Secondary Dislocation Rate of Dislocation as reported by patients in a complication. 3 Years
Secondary Survivorship Reports surivival of implant. 3 Years
Secondary Reports of Radiographic Loosening via Complication Form A more specific survivorship element; will indicate rate of loosening if it occurs. 3 Years
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