Triathlon Tritanium Knee Outcomes Study

NCT02155712 | Terminated Results FDA Device

• 1 other identifier: 74
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 10

Brief Summary

The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System

  Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.

  2 years

Secondary Outcomes (4)

• Implant Survivorship (Baseplate and Patella)

  10 years

• Compare 2011 Knee Society Score (KSS) Scores Between Both Groups

  2 years

• Compare Oxford Knee Score (OKS) Scores Between Both Groups

  2 years

• Compare Short Form-12 (SF-12) Scores Between Both Groups

  2 years

Study Arms (2)

Triathlon Tritanium Knee

ACTIVE COMPARATOR

Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.

Device: Triathlon Tritanium Knee

Triathlon Knee

ACTIVE COMPARATOR

Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.

Device: Triathlon Knee

Interventions

Triathlon Tritanium Knee DEVICE

Cementless

Triathlon Tritanium Knee

Triathlon Knee DEVICE

Cemented

Triathlon Knee

Eligibility Criteria

• Age: 18 Years - 75 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)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form.
• Patient is a male or non-pregnant female age 18-75 years at time of study device implantation.
• Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.
• 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 a diagnosis of avascular necrosis or inflammatory arthritis.
• 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.
• Subject 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 is diagnosed with lumbar radicular pain.
• Patient has a known sensitivity to device materials.
• Patient is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (10)

OrthoArizona

Gilbert, Arizona, 85234, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85741, United States

Location

Heekin Clinic

Jacksonville, Florida, 32204, United States

Location

Imperial Health

Lake Charles, Louisiana, 70605, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

St. Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

Location

Rothman Orthopaedic Institute

Egg Harbor, New Jersey, 08234, United States

Location

Mission Hospital Research Institute

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Geisinger Orthopaedic Institute

Danville, Pennsylvania, 17821, United States

Location

Results Point of Contact

• Title: Stryker JR Clinical Research
• Organization: Stryker Orthopaedics

StrykerJRClinical@stryker.com

201-831-5000

Study Officials

• Edward Petrow, DO

  Tucson Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Alvin Ong, MD

  Rothman Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• David Heekin, MD

  Heekin Clinic

  PRINCIPAL INVESTIGATOR

• Kipling Sharpe, MD

  OrthoArizona

  PRINCIPAL INVESTIGATOR

• Marcus Barnett, MD

  Mission Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• John Noble, MD

  Imperial Health

  PRINCIPAL INVESTIGATOR

• Michael Masini, MD

  St. Joseph Mercy Health System

  PRINCIPAL INVESTIGATOR

• Samuel Wellman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Ronald Delanois, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

• Thomas Bowen, MD

  Geisinger Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: October 1, 2014
• Primary Completion: April 5, 2018
• Study Completion: March 11, 2023
• Last Updated: November 14, 2023
• Results First Posted: July 16, 2019

Record last verified: 2023-10

Locations

US (10)