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Cementless Knee Replacement for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by DePuy Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject was diagnosed with NIDJD

Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive

Must not have

Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA

The Subject is a woman who is pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two types of cementless TKA RP systems to see which results in better functional performance as measured by the KOOS questionnaire.

Who is the study for?

This trial is for men and women aged 22-80 who are not bedridden, can consent to the study, understand procedures, complete questionnaires in English or translations provided, diagnosed with non-inflammatory degenerative joint disease (NIDJD), and suitable for cementless knee replacement. Exclusions include recent participation in other trials, litigation involvement, inflammatory arthritis conditions, life expectancy under five years, pregnancy/lactation status among others.

What is being tested?

The ATTUNE Cementless Total Knee Arthroplasty (TKA) system's performance is being tested. Specifically looking at functional improvements two years after surgery using the KOOS questionnaire. It compares cruciate retaining rotating platform and posterior stabilized rotating platform configurations of the TKA system.

What are the potential side effects?

While specific side effects are not listed here for this surgical intervention trial involving a cementless knee prosthesis system like ATTUNE TKA RP systems generally may have risks including pain at the site of surgery, infection risk post-operation, blood clots formation potential in legs or lungs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a non-inflammatory joint disease.

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I am between 22 and 80 years old.

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I am not confined to bed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have pain from my spine that spreads to the limb getting knee replacement.

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I am currently pregnant or breastfeeding.

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I have had surgery on my knee before, like a partial replacement or other specific procedures.

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I am diagnosed with a muscular disorder like fibromyalgia and take prescription medication for it.

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I have a condition like MS that affects my walking or ability to bear weight.

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I have gout that is not managed by my current treatment.

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I have a type of inflammatory arthritis like rheumatoid or psoriatic arthritis.

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I have had an amputation on the opposite side of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery) for reporting.