Cemented vs Cementless TKA

Early Outcomes of Cemented Versus Cementless Total Knee Arthroplasty Using the Triathlon Knee

The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction.

Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Triathlon total knee system

Detailed Description

The purpose of this study is to compare cemented and cementless versions of the Triathlon total knee arthroplasty/replacement (TKA) in terms of clinical outcomes, perioperative course, and outcome scores including function and patient satisfaction.

Patients who present to the clinical practices of Dr. Ryan Nunley, Dr. Robert Barrack, or Dr. Denis Nam and are suitable candidates for primary TKA will be screened for eligibility and invited to participate. Once enrolled participants will be randomized (1:1) to either receive a cemented or cementless Triathlon TKA. Data collected for the study will include standard of care clinical and radiographic evaluations collected during office visits and surgery, as well as study-specific patient questionnaires. Clinical, radiographic and questionnaire data will be collected pre-operatively, at the time of surgery, and at 6 weeks, 6 months, 1 year and beyond, and 2 years and beyond post-operatively. Patients will complete the following outcomes questionnaires preoperatively: New Knee Society Score, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D. The following questionnaires will be collected at four to six weeks, six months, one year and beyond, and two years and beyond postoperatively: New Knee Society Score, Forgotten Joint Score, Washington University Knee Satisfaction and Function Questionnaire, Oxford Knee Score, UCLA Activity Score, SF-12, and EQ-5D, and a Pain Drawing. In addition, a Pain Diary with a pain Visual Analog Scale (VAS) will be assessed once daily at home for 6 weeks after surgery.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patient between the ages of 18-75 getting a total knee surgery.

Description

Inclusion Criteria:

• Patients who qualify for a cementless primary total knee arthroplasty*
• 18 years of age but no more than 75 years of age
• Willing to be randomized
• Willing to sign informed consent
• Willing to return for all follow-up visits

Exclusion Criteria:

• Patients with inflammatory arthritis
• BMI equal to 40 or less.
• Patient with an active infection or suspected infection in the operative joint
• The absolute and relative contraindications stated in the FDA cleared labeling for the device
• Patients who have undergone osteotomy
• Patients who have had previous patella fracture or surgery
• Patients who have had previous healed tibia or femur fractures
• Patients who have had previous knee or hip replacement surgery on the ipsilateral side
• Patients who require patellar resurfacing
• Patients with major medical/muscular/orthopedic deformities

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cemented and cementless Triathlon group; cemented group are patients who get randomized to receive cemented knee implant and Patient randomized to receiving cement less knee implant.	Device: Triathlon total knee system; Implantable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in tourniquet time	Tourniquet time will be recorded for each patient during surgery to see if there is a difference between tourniquet time between patients who are receiving cemented vs cementless.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in functional pain score	Patients will fill out a visual analog scale at 6 weeks, 1 year, 2 year to determine if there is a difference between functional pain score between cemented vs. cementless.	2 years
knee society score	Knee society score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.	2 years
Forgotten joint score	Forgotten join score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.	2 year
Oxford knee score	Oxford knee score questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year.Subscales are summed together to compute total score.	2 years
UCLA Activity score	UCLA questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Scale from 1 to 10. Higher number represent better outcome. Lower numbers represent worst outcome.	2 year
SF-12 questionnaire	SF-12 questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.	2 year
EQ-5D	EQ-5D questionnaire will be completed preoperatively, 6 weeks, 1 year, and 2 year. Subscales are summed together to compute total score.	2 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 201308057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No