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Prosthesis

Total Knee Replacement for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by DePuy International

Eligibility Criteria Checklist

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

Must have

Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive

Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae

Must not have

Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee

Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum 15 years (5414 - 5658 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the long-term survivorship of a knee prosthesis in patients with non-inflammatory degenerative joint disease.

Who is the study for?

This trial is for adults aged 22-75 with non-inflammatory degenerative joint disease needing knee replacement. Candidates must be able to follow the study procedures, not bedridden, and not have conditions like fibromyalgia under treatment or disorders affecting gait. Pregnant women and those in other trials recently are excluded.

What is being tested?

The Attune Primary Total Knee Replacement's long-term effectiveness (up to 15 years) is being tested on patients with arthritis-related knee issues. The study pools data from four different knee configurations to create a comprehensive dataset.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of total knee replacement may include pain, swelling, infection risk at the surgery site, blood clots, and potential complications leading to further surgeries.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 75 years old.

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I am a good candidate for a specific knee replacement surgery as described.

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I am not confined to bed.

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I am between 22 and 75 years old.

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

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I am not confined to bed.

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I am a good candidate for a specific knee replacement surgery as described.

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

Exclusion Criteria

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

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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 currently taking medication for my diagnosed fibromyalgia.

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

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I am currently pregnant or breastfeeding.

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

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I am experiencing pain that spreads from my spine.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum 15 years (5414 - 5658 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum 15 years (5414 - 5658 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum 15 years (5414 - 5658 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survivorship of each configuration.

Secondary study objectives

Evaluate changes in femoral component and tibial component alignment

Evaluate the impact of surgeon learning curve on clinical and functional outcomes

Implant fixation: Radiographic assessment of bone-implant interface performance

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Attune Primary Total Knee ReplacementExperimental Treatment1 Intervention

Subjects will receive one of the following Attune total knee implants: Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)

0 / 15Eligibility criteria met