Triathlon PSR Outcomes Study

NCT ID: NCT04618770

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2023-01-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon PSR Tibial Insert

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

Group Type: OTHER

Triathlon PSR Tibial Insert

Intervention Type: 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.

Interventions

Triathlon PSR Tibial Insert

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.

2. Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation.

3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).

4. Patient is a candidate for primary cemented total knee replacement.

5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

1. Patient has a Body Mass Index (BMI) > 45.

2. Patient is already participating in the study for a contralateral total knee replacement.

3. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.

4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.

5. Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

6. Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.

7. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

8. Patient is diagnosed with lumbar radicular pain.

9. Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.

10. Patient has a known sensitivity to device materials.

11. Patient is a prisoner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OrthoCarolina

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

103

Identifier Type: -

Identifier Source: org_study_id