Overview

This trial is active, not recruiting.

Condition arthroplasty, replacement, knee
Treatment triathlon ts knee system
Sponsor Stryker Orthopaedics
Start date July 2009
End date April 2016
Trial size 181 participants
Trial identifier NCT00958789, 65

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Triathlon TS Knee System
triathlon ts knee system
Total knee replacement for revision cases

Primary Outcomes

Measure
Knee Society Score (KSS) change from preoperative time point to 2 years
time frame: pre-op, 2 years

Secondary Outcomes

Measure
The effect of joint line restoration on post-op stability, anterior knee pain & functional performance.
time frame: 2 years, 5 years
SF-36 Health Survey change from pre-op to post-op visits
time frame: pre-op, 1, 2, 5 years
Radiographic stability
time frame: 1, 2, 5 years
Revision rates
time frame: 5 years
Knee injury and Osteoarthritis Outcome Score (KOOS) change from pre-op to post-op visits
time frame: pre-op, 1, 2, 5 years
HSS Patella Score change from pre-op to post-op visits
time frame: pre-op, 1, 2, 5 years
Lower Extremity Activity Scale score change from pre-op to post-op visits
time frame: pre-op, 1, 2, 5 years
Knee Society Score (KSS) change from pre-op to post-op visits
time frame: pre-op, 1, 5 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has signed an 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.

Additional Information

Official title A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Stryker Orthopaedics.