Triathlon Total Stabilizer (TS) Outcomes Study

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958789
• Other study ID #: 65
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: March 28, 2019

Study information

• Verified date: October 2021
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 28, 2019
• Est. primary completion date: April 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Triathlon TS Knee System
Total knee replacement for revision cases

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of North Carolina Orthopedics	Chapel Hill	North Carolina
United States	Midwest Orthopaedics at Rush	Chicago	Illinois
United States	Wellington Orthopaedic & Sports Medicine	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Upstate Bone and Joint Center	East Syracuse	New York
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Heekin Institute for Orthopedic Research	Jacksonville	Florida
United States	The CORE Institute	Phoenix	Arizona
United States	Ridgewood Orthopedics	Ridgewood	New Jersey
United States	Scott & White Clinic	Temple	Texas
United States	The Orthopaedic Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years	KSS Pain score, KSS Function score, Total Combined KSS; The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.; Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).	pre-op, 2 years
Secondary	Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative	This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to = 5 mm and the other was those that were restored to > 5mm.; The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.	2 years, 5 years
Secondary	Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative	Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to = 5 mm and the other were restored to > 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes.; AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (= 5mm and > 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm.; ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (= 5mm and > 5mm) at 2 years and 5 years with all results in only one category of < 5 degrees.; The higher the number of degrees or mm measured the more instability in the knee.	2 year and 5 year postoperative
Secondary	Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative	Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to = 5 mm and the other was those that were restored to > 5mm.; Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.	2 year and 5 year postoperative
Secondary	Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits	The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.	pre-op, 1, 2, 5 years
Secondary	Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative	The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters.; The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.	1, 2, 5 years
Secondary	Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component	Revision was defined as the removal of either the femoral component or the tibial baseplate component.	5 years
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits	KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	pre-op, 1, 2, 5 years
Secondary	Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits	The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.	pre-op, 1, 2, 5 years
Secondary	Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits	The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.	pre-op, 1, 2, 5 years
Secondary	Knee Society Score (KSS) Change From Pre-op to Post-op Visits	The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.	pre-op, 1,2, 5 year