Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Vero Beach, Florida 32960


Purpose:

The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.


Criteria:

Inclusion Criteria: - Have knee joint disease related to one or more of the following - osteoarthritis - post-traumatic arthritis - inflammatory tissue disorders - arthritis secondary to other diseases - Avascular necrosis of the femoral condyles; - Skeletal maturity - Less than 70 on the Knee Society Score (rating score) - Sufficient bone stock, as judged by radiographs, to support primary knee implant - Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture - Patient is likely to be available for evaluation for the duration of the study - Able and willing to sign the informed consent and follow study procedures - Patient is not pregnant - No infection present - No known materials sensitivity Exclusion Criteria: - Skeletal immaturity - Greater than or equal to 70 on preoperative Knee Society Score (Rating Score) - Post-patellectomy - Insufficient bone quality which may affect implant stability - Insufficient collateral ligaments, as judged by the physician. Greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture. - Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity) - Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease) - Prisoners - Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity) - Patient is pregnant - Infection present - Materials sensitivity


NCT ID:

NCT00764894


Primary Contact:

Principal Investigator
Omar Hussamy, M.D.
Hussamy Orthopedics


Backup Contact:

N/A


Location Contact:

Vero Beach, Florida 32960
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.