Cementless Knee Replacement for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: DePuy Orthopaedics

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

Research Team

Sukhjeet Kaur

Principal Investigator

Sponsor GmbH

Eligibility Criteria

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.

Inclusion Criteria

Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations

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

I am between 22 and 80 years old.

See 4 more

Exclusion Criteria

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

I am currently pregnant or breastfeeding.

Contralateral knee has already been enrolled in this study

See 10 more

Treatment Details

Interventions

Cementless Total Knee Arthroplasty (Procedure)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ATTUNE Cementless RP TKAExperimental Treatment1 Intervention

Subjects will receive a cementless, rotating platform total knee arthroplasty