N/A
N=180
Triathlon Total Stabilizer (TS) Outcomes Study
Arthroplasty, Replacement, Knee
Bottom Line
View on ClinicalTrials.gov: NCT00958789 ↗Enrolled (actual)
180
Serious AEs
21.3%
Results posted
May 2017
Primary outcome: Primary: Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years — 39.81; 83.97; 41.43; 72.90 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Triathlon TS Knee System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Orthopaedics
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years |
39.81; 83.97; 41.43; 72.90; 82.96; 157.05 | — |
| SECONDARY Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative |
75.31; 70.00; 66.82; 71.36 | — |
| SECONDARY Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative |
47; 29; 2; 3; 30; 21 | — |
| SECONDARY Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative |
45; 28; 5; 4; 26; 20 | — |
| SECONDARY Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits |
32.43; 41.30; 40.55; 38.42; 45.85; 52.57 | — |
| SECONDARY Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative |
2; 0; 0 | — |
| SECONDARY Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component |
5; 9 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits |
41.51; 75.09; 74.67; 73.95; 43.39; 73.02 | — |
| SECONDARY Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits |
45.09; 76.68; 80.08; 78.56 | — |
| SECONDARY Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits |
7.80; 9.65; 9.60; 9.75 | — |
| SECONDARY Knee Society Score (KSS) Change From Pre-op to Post-op Visits |
39.81; 85.45; 83.97; 82.06; 41.43; 74.18 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00958789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.