Clinical trial NCT04630262: ATTUNE Cementless FB Tibial Base Clinical Study
Official title: Multi-Center Clinical Investigation of the ATTUNE® Cementless Fixed Bearing Tibial Base and Cementless Patella Implants in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Post-traumatic arthritis
Failed total knee
Knee
Total knee arthroplasty
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ATTUNE Cementless Fixed Bearing
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.

Detailed description: The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window. Study success will be determined using the primary TKA (CR FB and PS FB combined) analysis group.

The secondary objectives of this study are to establish the surgical effectiveness of the ATTUNE Cementless Tibial Base by evaluating type and frequency of Adverse Events and Device Deficiencies, functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for all subjects (CR FB and PS FB combined) at the 1-year timepoint, the change from preoperative baseline to the 6-week, 6-month, 1-year, 2-year and 5-year timepoints in functional outcomes and quality of life assessments, as measured using additional patient reported outcomes measures (PROMS), implant survivorship of the ATTUNE Cementless FB Tibial base using Kaplan-Meier survival analysis at 1, 2 and 5-year timepoints, and investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 months 1, 2 and 5 years after surgery.

Eligibility criteria: Inclusion Criteria:

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
2. Subject has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present.
3. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor.
4. Subject is currently not bedridden.
5. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
6. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.

Exclusion Criteria:

* a) The Subject is a woman who is pregnant or lactating. b) Contralateral knee has already been enrolled in this study . c) Revision knee that was previously enrolled in the study as a primary knee (ipsilateral).

  d) Subject has participated in a clinical study with an investigational product (drug or device) in the last two (2) years.

  e) Subject has had surgery on their contralateral knee within six (6) months of study enrolment or has surgery planned on their contralateral knee less than six (6) months of the study surgery.

  f) Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).

  g) Active local or systemic infection. h) Loss of bone or musculature, inadequate bone quality (e.g. severe osteoporosis), neuromuscular compromise or vascular deficiency at the bone site in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures that could lead to implant instability, joint neuropathy).

  i) Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.

  j) The inability to make bone cuts (e.g. inadequate bone stock) so as to assure correct component position, a firm press fit, and intimate apposition of the cut bone and prosthetic surfaces.

  k) Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

  l) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last five 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

Primary outcomes:
measure: One Year Functional Responder Rate of First 225 Subjects
timeFrame: through study completion, up to 10 months
Secondary outcomes:
measure: Measure of Knees With Adverse Events
timeFrame: Through study completion, up to 10 months
measure: Mean Number of Adverse Events Per Knee for Knees With Reported AEs
timeFrame: Through study completion, up to 10 months
measure: Measure of Knees With Device Deficiencies
timeFrame: Through study completion, up to 10 months
measure: Mean Number of Device Deficiencies Per Knee
timeFrame: Through study completion, up to 10 months
measure: One Year Functional Responder Rate All Subjects
timeFrame: Through study completion, up to 10 months.
measure: One Year Kaplan-Meier Implant Survivorship
timeFrame: Through study completion, up to 10 months
measure: Two Year Kaplan-Meier Implant Survivorship
timeFrame: Through study completion, up to 10 months
measure: Five Year Kaplan-Meier Implant Survivorship
timeFrame: Through study completion, up to 10 months
measure: 6 Week Knee Society Score
timeFrame: Through study completion, up to 6 weeks
measure: 6 Month Knee Society Score
timeFrame: Through study completion, up to 6 Months
measure: One Year Knee Society Score
timeFrame: Through study completion, up to 10 months
measure: Two Year Knee Society Score
timeFrame: Through study completion, up to 10 months
measure: Five Year Knee Society Score
timeFrame: Through study completion, up to 10 months
measure: Six Week Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Through study completion, up to 6 weeks
measure: Six Month Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Through study completion, up to 6 Months
measure: One Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Through study completion, up to 10 months
measure: Two Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Through study completion, up to 10 months
measure: Five Year Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Through study completion, up to 10 months
measure: Six Week Forgotten Joint Score (FJS-12)
timeFrame: Through study completion, up to 6 weeks
measure: Six Month Forgotten Joint Score (FJS-12)
timeFrame: Through study completion, up to 6 months
measure: 1 Year Forgotten Joint Score (FJS-12)
timeFrame: Through study completion, up to 10 months
measure: Two Year Forgotten Joint Score (FJS-12)
timeFrame: Through study completion, up to 10 months
measure: Five Year Forgotten Joint Score (FJS-12)
timeFrame: Through study completion, up to 10 months
measure: Six Week EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Through study completion, up to 6 weeks
measure: Six Month EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Through study completion, up to 6 months
measure: One Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Through study completion, up to 10 months
measure: Two Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Through study completion, up to 10 months
measure: Five Year EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Through study completion, up to 10 months
measure: Six Month Investigator-conducted Radiographic Analysis
timeFrame: Through study completion, up to 6 Months
measure: One Year Investigator-conducted Radiographic Analysis
timeFrame: Through study completion, up to 10 months
measure: Two Year Investigator-conducted Radiographic Analysis
timeFrame: Through study completion, up to 10 months
measure: Five Year Investigator-conducted Radiographic Analysis
timeFrame: Through study completion, up to 10 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Bradenton
country: United States
facility: Coastal Orthopedics
state: Florida
city: DeLand
country: United States
facility: Florida Orthopaedic Associates
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: American Hip Institute & Orthopedic Specialists
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Orthpaedic Surgery
state: Maryland
city: Baltimore
country: United States
facility: Towson Orthopaedic Associates
state: Maryland
city: Baltimore
country: United States
facility: Rubin Institute for Advanced Orthopedics
state: Maryland
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Ozark
country: United States
facility: Mercy Clinic Springfield
state: Missouri
city: Somerset
country: United States
facility: University Orthopaedic Associates, LLC
state: New Jersey
city: Garden City
country: United States
facility: Orlin & Cohen Orthopedics
state: New York
city: Alexandria
country: United States
facility: Anderson Clinic
state: Virginia
Study officials:
affiliation: DePuy Synthes
name: Allyson Morris
role: STUDY_DIRECTOR
References: