Triathlon Total Stabilizer (TS) Outcomes Study

NCT00958789 | Completed Results

• 1 other identifier: 65
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 12

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative

  2 years, 5 years

• Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative

  2 year and 5 year postoperative

• Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative

  2 year and 5 year postoperative

• Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits

  pre-op, 1, 2, 5 years

• Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative

  1, 2, 5 years

Study Arms (1)

Triathlon TS Knee

OTHER

Triathlon TS Knee System

Device: Triathlon TS Knee System

Interventions

Triathlon TS Knee System DEVICE

Total knee replacement for revision cases

Triathlon TS Knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (12)

The CORE Institute

Phoenix, Arizona, 85023, United States

Location

Heekin Institute for Orthopedic Research

Jacksonville, Florida, 32204, United States

Location

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Ridgewood Orthopedics

Ridgewood, New Jersey, 07450, United States

Location

Upstate Bone and Joint Center

East Syracuse, New York, 13057, United States

Location

University of North Carolina Orthopedics

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Wellington Orthopaedic & Sports Medicine

Cincinnati, Ohio, 45255, United States

Location

The Orthopaedic Center

Tulsa, Oklahoma, 74120, United States

Location

Scott & White Clinic

Temple, Texas, 76508, United States

Location

Results Point of Contact

• Title: Ellen Axelson, Director, Clinical Operations
• Organization: Stryker Orthopaedics

ellen.axelson@stryker.com

201-831-5401

Study Officials

• Kirby D Hitt, M.D.

  Scott & White Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: July 1, 2009
• Primary Completion: April 25, 2016
• Study Completion: March 28, 2019
• Last Updated: October 22, 2021
• Results First Posted: May 19, 2017

Record last verified: 2021-10

Locations

US (12)