Clinical trial NCT00819481: Post-Market Study of the 3DKnee™ System
Official title: Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Joint Disease
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Keywords: Total knee replacement
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are over 18 years of age and are candidates for a primary total knee replacement.

Brief summary: The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

Detailed description: Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* This must be a primary knee replacement on this knee.
* Patient is over 18 years of age or older
* Have knee joint disease related to one or more of the following

  * degenerative joint disease, including osteoarthritis or traumatic arthritis
  * Avascular necrosis of the femoral condyles
  * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  * Moderate valgus, varus, or flexion deformities
  * Rheumatoid arthritis
* 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

Exclusion Criteria:

* Is younger than 18 years of age
* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant

Primary outcomes:
measure: efficacy of total knee system
timeFrame: 2 year
Secondary outcomes:
measure: change in Knee Society Score
timeFrame: 5 year
measure: change in pain from pre-op to post-op
timeFrame: 5 year
measure: patient satisfaction
timeFrame: 5 year
measure: change in WOMAC Osteoarthritis Index from pre-surgery
timeFrame: 5 year
measure: change in Oxford Knee Score from pre-surgery
timeFrame: 5 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Longo Orthopedics
state: Arizona
city: Fresno
country: United States
facility: Center for Excellence
state: California
city: Baltimore
country: United States
facility: OrthoMaryland
state: Maryland
city: Silver Spring
country: United States
facility: Metro Orthopedics and Sports Therapy
state: Maryland
city: Camdenton
country: United States
facility: Leslie Orthopedics and Sports Medicine
state: Missouri
city: Saint Peters
country: United States
facility: St. Peter's Bone & Joint Surgery
state: Missouri
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Saint George
country: United States
facility: Rimrock Orthopedics
state: Utah
Study officials:
affiliation: St. Peter's Bone and Joint Surgery
name: John W. McAllister, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoMaryland
name: Barry J Waldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: