Clinical trial NCT00958789: Triathlon Total Stabilizer (TS) Outcomes Study
Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.


Eligibility criteria: Inclusion Criteria:

* Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
* Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 40.
* Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a failed unicondylar knee prosthesis.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.

Primary outcomes:
measure: Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
timeFrame: pre-op, 2 years
Secondary outcomes:
measure: Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
timeFrame: 2 years, 5 years
measure: Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
timeFrame: 2 year and 5 year postoperative
measure: Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
timeFrame: 2 year and 5 year postoperative
measure: Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
timeFrame: pre-op, 1, 2, 5 years
measure: Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
timeFrame: 1, 2, 5 years
measure: Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
timeFrame: 5 years
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
timeFrame: pre-op, 1, 2, 5 years
measure: Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
timeFrame: pre-op, 1, 2, 5 years
measure: Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
timeFrame: pre-op, 1, 2, 5 years
measure: Knee Society Score (KSS) Change From Pre-op to Post-op Visits
timeFrame: pre-op, 1,2, 5 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
city: Jacksonville
country: United States
facility: Heekin Institute for Orthopedic Research
state: Florida
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Ridgewood
country: United States
facility: Ridgewood Orthopedics
state: New Jersey
city: East Syracuse
country: United States
facility: Upstate Bone and Joint Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Orthopedics
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Wellington Orthopaedic & Sports Medicine
state: Ohio
city: Tulsa
country: United States
facility: The Orthopaedic Center
state: Oklahoma
city: Temple
country: United States
facility: Scott & White Clinic
state: Texas
Study officials:
affiliation: Scott & White Hospital
name: Kirby D Hitt, M.D.
role: STUDY_CHAIR
References: