Triathlon Knee Replacement for Knee Arthritis

(APT Trial)

Recruiting at 4 trial locations

Overseen By Marissa Puccio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: Infection, Skeletal immaturity, Neuromuscular disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

204 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Triathlon Knee Replacement treatment for knee arthritis?

Research shows that the Triathlon Knee Replacement treatment leads to significant improvements in pain, function, and quality of life within the first three months after surgery, with these benefits lasting up to 10 years. The treatment also has a high satisfaction rate, with 79%-94% of patients satisfied, and a 95.4% survivorship rate at 10 years. ^{1 2 3 4 5}

Is the Triathlon Knee Replacement safe for humans?

The Triathlon Knee Replacement has been shown to be generally safe, with studies reporting good outcomes and high satisfaction rates up to 10 years after surgery. The all-polyethylene version of the knee component showed less movement, suggesting a lower risk of loosening compared to the metal-backed version. ^{1 2 3 4 6}

What makes the Triathlon All-Polyethylene Tibia Knee treatment unique for knee arthritis?

The Triathlon All-Polyethylene Tibia Knee treatment is unique because it is designed to improve knee motion and has a high rate of long-term success, with studies showing excellent outcomes and survivorship up to 10 years after surgery. This treatment uses advanced implant design and materials, which contribute to its durability and effectiveness in improving patient function and satisfaction. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

Eligibility Criteria

This trial is for adults over 18 who have had a primary total knee replacement using the Triathlon All-Polyethylene Tibia and compatible components, without plans for revision. Participants must be able to follow up with clinical evaluations. Those with infections, compromised bone stock, mental or neuromuscular disorders, excessive steroid use, or are prisoners cannot join.

Inclusion Criteria

I have a Triathlon knee implant with no plans for changes.

Patient has signed an IRB-approved, study specific Informed Patient Consent Form.

I am willing and able to follow up with all required post-surgery check-ups and scans.

Exclusion Criteria

Patient is a prisoner.

My knee is very unstable because of damaged ligaments.

I was on high-dose steroids or had a weakened immune system during my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Data obtained retrospectively from medical records from preoperative to shortly after surgery

Not specified

Follow-up

Participants are evaluated at their 5-year and 10-year post-surgery anniversary dates

10 years

Evaluations at 5-year and 10-year postoperative

Treatment Details

Interventions

• Triathlon All-Polyethylene Tibia Knee

Trial Overview The study aims to assess the functional outcomes of patients who received the Triathlon All-Polyethylene Tibia Knee Device during knee replacement surgery. It will involve scheduled clinical and radiographic evaluations post-surgery.

Participant Groups

Group I: Triathlon All-Polyethylene Tibia Knee Experimental Treatment 1 Intervention

All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.

Triathlon All-Polyethylene Tibia Knee is already approved in United States, European Union for the following indications:

Approved in United States as Triathlon All-Polyethylene Tibia for:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis)
• Rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Approved in European Union as Triathlon All-Polyethylene Tibia for:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis)
• Rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

Findings from Research

The Stryker Triathlon Total Knee System shows excellent survivorship rates of 98.7% overall and 99.2% for aseptic causes, based on a systematic review of 20 studies with a mean follow-up of 3.8 years.

Clinical outcomes are also promising, with average Knee Society Scores (KSS) indicating high levels of pain relief (92.2) and functional improvement (82.7), suggesting effective performance of the cementless implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and survivorship of cementless triathlon total knee arthroplasties: a systematic review. Carlson, BJ., Gerry, AS., Hassebrock, JD., et al.[2022]

The Triathlon total knee replacement (TKR) showed excellent outcomes, with a 95.4% survivorship rate at 10 years post-surgery, indicating its long-term reliability for patients.

Patients experienced significant improvements in pain and function within the first three months after surgery, with satisfaction rates ranging from 79% to 94% over the follow-up period, demonstrating the effectiveness of the Triathlon prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. Wylde, V., Penfold, C., Rose, A., et al.[2021]

Patients with the Triathlon(®) total knee replacement reported significantly better outcomes in pain relief, function, quality of life, and satisfaction compared to those with the Kinemax Plus prosthesis, based on a study of 453 knees (233 Kinemax Plus and 220 Triathlon) with follow-up at 3 months and 1 year post-surgery.

The Triathlon(®) prosthesis appears to facilitate a quicker return to function and greater pain reduction within the first three months after surgery, indicating its potential advantages over the previous design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of patient reported outcomes after Triathlon(®) and Kinemax Plus prostheses. Dixon, S., Blom, AW., Whitehouse, MR., et al.[2021]

In a study involving 60 patients, both the posterior stabilised and cruciate retaining versions of the Triathlon™ total knee prosthesis showed similar early stability in terms of tibial component migration over a two-year follow-up period.

Despite differences in specific types of movement (translation) between the two prosthesis types, there were no significant differences in clinical outcomes or functional performance, indicating both designs are effective options for knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial. Molt, M., Toksvig-Larsen, S.[2014]

In a study of 266 patients who received a Triathlon knee replacement, significant improvements in pain, function, and quality of life were observed within the first 3 months post-surgery, with smaller gains continuing up to 12 months.

The survivorship rate of the Triathlon knee replacement was high at 96.6% after 5 years, and 86% of patients reported satisfaction with their outcomes, indicating good mid-term effectiveness of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5 Year Outcomes and Survivorship of the Triathlon Total Knee Replacement: a Cohort Study. Wylde, V., Dixon, S., Miller, LL., et al.[2019]

In a study involving 59 patients, the all-polyethylene tibial component showed significantly less migration than the metal-backed component after 2 years, indicating a potentially lower risk of late aseptic loosening.

Both all-polyethylene and metal-backed groups demonstrated similar improvements in clinical outcomes, suggesting that while the all-polyethylene design may have advantages in migration, it does not compromise overall functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Migration of all-polyethylene compared with metal-backed tibial components in cemented total knee arthroplasty. Van Hamersveld, KT., Marang-Van De Mheen, PJ., Nelissen, RGHH., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes and survivorship of cementless triathlon total knee arthroplasties: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of patient reported outcomes after Triathlon(®) and Kinemax Plus prostheses. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial. [2014]

5. Belgium pubmed.ncbi.nlm.nih.gov

5 Year Outcomes and Survivorship of the Triathlon Total Knee Replacement: a Cohort Study. [2019]

6. Sweden pubmed.ncbi.nlm.nih.gov

Migration of all-polyethylene compared with metal-backed tibial components in cemented total knee arthroplasty. [2019]