Clinical trial NCT00957723: Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
Official title: A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 419
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

Detailed description: The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.

Eligibility criteria: Inclusion Criteria:

1. The subject is a male or non-pregnant female between the ages of 21 and 80.
2. The subject requires a primary cemented total knee replacement.
3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
4. The subject has intact collateral ligaments.
5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form.
6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has inflammatory arthritis.
2. The subject is morbidly obese, BMI \> 40.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. Patient has had a high tibial osteotomy or femoral osteotomy.
5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
7. The subject is immunologically suppressed, or receiving chronic steroids (\> 30 days duration).
8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis.
9. The subject has had a knee fusion to the affected joint.
10. The subject has an active or suspected latent infection in or about the knee joint.
11. The subject is a prisoner.

Primary outcomes:
measure: Active Range of Motion
timeFrame: 2 Years
Secondary outcomes:
measure: Change in Knee Society Score (KSS) Over Time
timeFrame: preoperative, 1, 2, and 5 years
measure: Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
timeFrame: 1, 2, and 5 years
measure: Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
timeFrame: 1, 2, and 5 years
measure: Change in SF-36 Health Survey Over Time
timeFrame: preoperative, 1, 2, 3, 4, and 5 years
measure: Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
timeFrame: preoperative,1, 2, 3, 4 and 5 years
measure: Change in Lower-Extremity Activity Scale (LEAS) Over Time
timeFrame: preoperative, 1, 2, 3, 4, and 5 years
measure: Patellar Subluxation, Dislocation and Fracture Rate
timeFrame: 5 years
measure: Patient Outcome Long Term Follow-up Questionnaire Over Time
timeFrame: 6, 7, 8, 9, and 10 years
measure: Implant Survivorship
timeFrame: 10 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Institute for Bone and Joint Disorders
state: Arizona
city: Miami
country: United States
facility: Cedars Medical Center University of Miami
state: Florida
city: Columbus
country: United States
facility: Hughston Sports Medicine Center
state: Georgia
city: Cedar Rapids
country: United States
facility: Physician's Clinic of Iowa, Mercy Medical Center
state: Iowa
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
city: Buffalo
country: United States
facility: Buffalo General Hospital, Department of Orthopaedics Kaleida Health
state: New York
city: Akron
country: United States
facility: Crystal Clinic
state: Ohio
city: Bend
country: United States
facility: The Center: Orthopaedic & Neurosurgical Care & Research
state: Oregon
city: Knoxville
country: United States
facility: Knoxville Orthopaedic Clinic
state: Tennessee
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare
state: Wisconsin
Study officials:
affiliation: The Center: Orthopaedic & Neurosurgical Care & Research
name: Knute Buehler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Knoxville Orthopedic Clinic
name: Brian Covino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aurora Advanced Healthcare
name: Joseph Davies, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Crystal Clinic
name: Kenneth Greene, MD
role: STUDY_CHAIR
affiliation: Arizona Institute for Bone and Joint Disorders
name: Anthony Hedley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott & White Memorial Hospital
name: Kirby Hitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newton-Wellesley Hospital
name: Joseph McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician's Clinic of Iowa, PC
name: Jeffrey Nassif, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buffalo General Hospital, Department of Orthopaedics
name: Kenneth Krackow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars Medical Center University of Miami
name: Sean Scully, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hughston Sports Medicine Center
name: Carlton Savory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buffalo General Hospital, Department of Orthopaedics
name: Mathew Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: