Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study

NCT00957021 | Completed Results

• 1 other identifier: 55
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Knee

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.

  2 years

Secondary Outcomes (5)

• Patient Outcome Knee Society Score

  1,2 and 5 years

• Patient Outcome SF-36

  1,2,3,4 and 5 years

• Patient Outcome WOMAC

  5 years

• Patient Outcome Lower-Extremity Activity Scale

  1,2,3,4 and 5 years

• Radiographic Outcome

  1,2 and 5 years

Study Arms (1)

Triathlon® PS Total Knee System

OTHER

Triathlon® PS Total Knee System

Device: Triathlon® PS Total Knee System

Interventions

Triathlon® PS Total Knee System DEVICE

Triathlon® PS Total Knee system

Triathlon® PS Total Knee System

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.
• The subject requires a primary cemented total knee replacement.
• The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
• The subject has intact collateral ligaments.
• The subject has signed the IRB approved, study specific Informed Patient Consent Form.
• The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

• The subject has inflammatory arthritis.
• The subject is morbidly obese, BMI \> 40.
• The subject has a history of total or unicompartmental reconstruction of the affected joint.
• The subject has had a high tibial osteotomy or femoral osteotomy.
• The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
• The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
• The subject is immunologically suppressed, or receiving chronic steroids (\>30 days duration).
• The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
• The subject has had a knee fusion at the affected joint.
• The subject has an active or suspected latent infection in or about the knee joint.
• The subject is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (11)

Hughston Clinic PA

Columbus, Georgia, 31908, United States

Location

Ireland Hip and Knee Surgery

Indianapolis, Indiana, 46260, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital

Boston, Massachusetts, 02445, United States

Location

St. Cloud Orthopaedic Associates

Sartell, Minnesota, 56377, United States

Location

New Hampshire Orthopaedic Surgery, PA

Manchester, New Hampshire, 03103, United States

Location

Specialty Orthopaedics

Harrison, New York, 10528, United States

Location

Wellington Orthopaedics & Sports Medicine

Cincinnati, Ohio, 45255, United States

Location

Tri County Orthopedic Surgeons, Inc.

Massillon, Ohio, 44646, United States

Location

Kelsey-Seybold Clinic

Houston, Texas, 77025, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Stryker Orthopaedics

Ellen.Axelson@Stryker.com

201-831-5401

Study Officials

• Eric R Benson, MD

  New Hampshire Orthopaedic Surgery, PA

  PRINCIPAL INVESTIGATOR

• Daniel Moretta, DO

  Tri County Orthopedics Surgeons, Inc.

  PRINCIPAL INVESTIGATOR

• James Bono, MD

  New England Baptist Hospital

  PRINCIPAL INVESTIGATOR

• David W Edelstein, MD

  Kelsey-Seybold Clinic

  PRINCIPAL INVESTIGATOR

• Philip Ireland, MD

  Ireland Hip and Knee Surgery

  PRINCIPAL INVESTIGATOR

• Joseph P Nessler, MD

  St. Cloud Orthopaedic Associates

  PRINCIPAL INVESTIGATOR

• Quanjun Cui, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Arnold Scheller, MD

  Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital

  PRINCIPAL INVESTIGATOR

• Joel Sorger, MD

  Wellington Orthopaedics and Sports Medicine

  PRINCIPAL INVESTIGATOR

• Suresh Nayak, MD

  Wellington Orthopaedics and Sports Medicine

  PRINCIPAL INVESTIGATOR

• John I Waldrop, MD

  Hughston Clinic, PA

  PRINCIPAL INVESTIGATOR

• James McGrory, MD

  Hughston Clinic, PA

  PRINCIPAL INVESTIGATOR

• Steven B Zelicof, MD, PhD

  Specialty Orthopaedics

  PRINCIPAL INVESTIGATOR

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 10, 2009
• First Posted: August 12, 2009
• Study Start: December 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: January 1, 2014
• Last Updated: January 25, 2017
• Results First Posted: December 5, 2013

Record last verified: 2016-11

Locations

US (11)