Triathlon PSR Outcomes Study

Arthroplasty Clinical Trial

Official title:

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04618770
• Other study ID #: 103
• Status: Terminated
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: December 2023
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty
• Knee

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	OrthoCarolina	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EuroQol-5 Dimension (EQ-5D)	The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.; With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	PreOp, 6 week, 1 year
Secondary	Range of Motion	Range of Motion evaluates how much the knee can be bent and straightened. The normal range of motion is typically 0 to 135 degrees.	PreOp, 6 weeks, 1 year
Secondary	Survivorship of Triathlon PSR Insert	All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year.	1 Year