Triathlon PSR Outcomes Study

NCT04618770 | Terminated Results FDA Device

• 1 other identifier: 103
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.

Conditions

Arthroplasty; Knee

Outcome Measures

Primary Outcomes (1)

• Mean SF-36 Physical Component Score

  The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

  pre-operative, 6 weeks, 1 year

Secondary Outcomes (3)

• EuroQol-5 Dimension (EQ-5D)

  PreOp, 6 week, 1 year

• Range of Motion

  PreOp, 6 weeks, 1 year

• Survivorship of Triathlon PSR Insert

  1 Year

Study Arms (1)

Triathlon PSR Tibial Insert

OTHER

Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert

Device: Triathlon PSR Tibial Insert

Interventions

Triathlon PSR Tibial Insert DEVICE

The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.

Triathlon PSR Tibial Insert

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 IRB/EC approved; study specific Informed Patient Consent Form.
• Patient is a male or non-pregnant female, skeletally mature, 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 cemented 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) \> 45.
• Patient is already participating in the study for a contralateral total knee replacement.
• 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 any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.
• 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 severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
• Patient has a known sensitivity to device materials.
• Patient is a prisoner.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed due to lack of enrollment.

Results Point of Contact

• Title: Kevin Barga
• Organization: Stryker

kevin.barga@stryker.com

2018315073

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: November 2, 2020
• First Posted: November 6, 2020
• Study Start: February 8, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: December 11, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-12

Locations

US (1)