Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

NCT00957723 | Completed Results

• 1 other identifier: 56
• Study Type: interventional
• Target: 419
• 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® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Active Range of Motion

  2 Years

Secondary Outcomes (9)

• Change in Knee Society Score (KSS) Over Time

  preoperative, 1, 2, and 5 years

• Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)

  1, 2, and 5 years

• Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score

  1, 2, and 5 years

• Change in SF-36 Health Survey Over Time

  preoperative, 1, 2, 3, 4, and 5 years

• Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time

  preoperative,1, 2, 3, 4 and 5 years

Study Arms (1)

Triathlon® CR Total Knee System

OTHER

Participants receive the Triathlon® CR Total Knee System

Device: Triathlon® CR Total Knee System

Interventions

Triathlon® CR Total Knee System DEVICE

The purpose is to evaluate the Triathlon® CR Total Knee System.

Triathlon® CR 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 between the ages of 21 and 80.
• 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:

• Patient has inflammatory arthritis.
• The subject is morbidly obese, BMI \> 40.
• The subject has a history of total or unicompartmental reconstruction of the affected joint.
• Patient has had a high tibial osteotomy or femoral osteotomy.
• The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
• The patient 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, which cannot provide adequate support and/or fixation to the prothesis.
• The subject has had a knee fusion to 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)

Arizona Institute for Bone and Joint Disorders

Phoenix, Arizona, 85016, United States

Location

Cedars Medical Center University of Miami

Miami, Florida, 33136, United States

Location

Hughston Sports Medicine Center

Columbus, Georgia, 31908, United States

Location

Physician's Clinic of Iowa, Mercy Medical Center

Cedar Rapids, Iowa, 52401, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Buffalo General Hospital, Department of Orthopaedics Kaleida Health

Buffalo, New York, 14203, United States

Location

Crystal Clinic

Akron, Ohio, 44330, United States

Location

The Center: Orthopaedic & Neurosurgical Care & Research

Bend, Oregon, 97701, United States

Location

Knoxville Orthopaedic Clinic

Knoxville, Tennessee, 37909, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Aurora Advanced Healthcare

Milwaukee, Wisconsin, 53233, United States

Location

Results Point of Contact

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

Ellen.Axelson@Stryker.com

201-831-5401

Study Officials

• Knute Buehler, MD

  The Center: Orthopaedic & Neurosurgical Care & Research

  PRINCIPAL INVESTIGATOR

• Brian Covino, MD

  Knoxville Orthopedic Clinic

  PRINCIPAL INVESTIGATOR

• Joseph Davies, MD

  Aurora Advanced Healthcare

  PRINCIPAL INVESTIGATOR

• Kenneth Greene, MD

  Crystal Clinic

  STUDY CHAIR

• Anthony Hedley, MD

  Arizona Institute for Bone and Joint Disorders

  PRINCIPAL INVESTIGATOR

• Kirby Hitt, MD

  Scott & White Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Joseph McCarthy, MD

  Newton-Wellesley Hospital

  PRINCIPAL INVESTIGATOR

• Jeffrey Nassif, MD

  Physician's Clinic of Iowa, PC

  PRINCIPAL INVESTIGATOR

• Kenneth Krackow, MD

  Buffalo General Hospital, Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

• Sean Scully, MD

  Cedars Medical Center University of Miami

  PRINCIPAL INVESTIGATOR

• Carlton Savory, MD

  Hughston Sports Medicine Center

  PRINCIPAL INVESTIGATOR

• Mathew Phillips, MD

  Buffalo General Hospital, Department of 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: February 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: September 26, 2017
• Last Updated: October 12, 2018
• Results First Posted: April 8, 2014

Record last verified: 2018-10

Locations

US (11)