Triathlon Tritanium Cone Augments Outcomes Study

Arthroplasty Clinical Trial

Official title:

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02521103
• Other study ID #: 76
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 2033

Study information

• Verified date: January 2024
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: February 2033
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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, skeletally mature and 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) > 45.
• 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
• Knee
• Replacement

Intervention

Device:
• Triathlon Tritanium Cone Augments
The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in primary or revision TKA

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Missouri Orthopaedic Institute	Columbia	Missouri
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Bluegrass Orthopaedics	Lexington	Kentucky
United States	The CORE Institute	Novi	Michigan
United States	Providence Medical Research Center	Spokane	Washington
United States	The Orthopaedic Center	Tulsa	Oklahoma
United States	Michigan Heart, St. Joseph Health System	Ypsilanti	Michigan
United States	Florida Medical Clinic	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening		2 year
Secondary	Presence of end-of-stem pain in relation to the Triathlon Tritanium Cone Augments location.	End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain location.	2 year
Secondary	Severity of end-of-stem pain.	End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain.; Pain for both the shin and thigh are identified using the following categories: no pain; pain with extreme activity only; pain with moderate activity; pain with normal activity; pain at rest	2 year
Secondary	Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.	The AORI is a bone defect classification which consists of four Types: Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability; Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.; Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.; Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed	intraoperative
Secondary	Anderson Orthopaedic Research Institute (AORI) classification and Tibial Symmetric Cone Augment size.	The AORI is a bone defect classification which consists of four Types: Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability; Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.; Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.; Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed	intraoperative
Secondary	Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.	The AORI is a bone defect classification which consists of four Types: Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability; Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.; Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.; Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed	intraoperative