ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Primary Knee Arthroplasty Clinical Trial

Official title:

Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153449
• Other study ID #: DSJ-2016-03
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2017
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2024
• Source: DePuy Orthopaedics
• Contact: Grant Jamgochian
• Phone: +1 484-685-6404
• Email: gjamgoch[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

Description:

Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint. This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations. The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2028
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

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

2. The decision to have knee replacement with the study device is regardless of the research.

3. The devices are to be used according to the approved indications.

4. 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

5. Subject is currently not bedridden.

6. 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.

7. 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.

8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)

Exclusion Criteria:

1. The Subject is a woman who is pregnant or lactating.

2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.

3. Subject had a contralateral amputation.

4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.

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

6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.

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

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

9. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.

10. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).

11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.

12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.). -

Related Conditions & MeSH terms

• Primary Knee Arthroplasty

Intervention

Device:
• ATTUNE Revision Knee System in Total Knee Arthroplasty
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty

Locations

Country	Name	City	State
Australia	Finders Private Hospital	Adelaide
Australia	St. John of God Murdoch Hospital	Perth
Austria	Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.	Linz
Belgium	MoRe Foundation	Antwerp
Canada	London Health Sciences Centre University Hospital	London	Ontario
Canada	Concordia Joint Replacement	Winnipeg
France	Centre Hospitalier Universitaire de Rennes	Rennes
Germany	Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche	Munich
Germany	Asklepios Orthopädische Klinik Lindenlohe	Schwandorf
Ireland	South Infirmary Public Hospital	Cork
Italy	Ospedale Sacro Cuore	Verona
Netherlands	University Hospital Maastricht	Maastricht
New Zealand	Wellington Hospital	Wellington
Switzerland	Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology	Basel
United Kingdom	Hampshire Hospitals NHS Foundation Trust	Basingstoke
United Kingdom	Victoria Hospital NHS Fife	Kirkcaldy
United Kingdom	Chapel Allerton Orthopaedic Centre	Leeds
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust	Oswestry
United Kingdom	Nuffield Orthopaedic Centre	Oxford
United Kingdom	Wrightington Hospital	Wigan
United States	Texas Institute for Hip & Knee Surgery	Austin	Texas
United States	UNC Orthopaedics	Chapel Hill	North Carolina
United States	OrthoCarolina Hip and Knee Center	Charlotte	North Carolina
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Florida Orthopedic Associates	DeLand	Florida
United States	Colorado Joint Replacement	Denver	Colorado
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Orthopaedic Center of the Rockies	Fort Collins	Colorado
United States	Fondren Orthopedic Group	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Arthroplasty Foundation	Louisville	Kentucky
United States	Southern Joint Replacement Institute	Nashville	Tennessee
United States	Orthopedic Partners	Niantic	Connecticut
United States	Mery Hospital	Ozark	Missouri
United States	Scripps Clinic Torrey Pines	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  France,  Germany,  Ireland,  Italy,  Netherlands,  New Zealand,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS ADL	Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.	2 Years
Secondary	Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)	Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM).	Baseline, 5 Year
Secondary	Patient's Knee Implant Performance (PKIP)	Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure	Baseline, 5 Year
Secondary	American Knee Society Score	valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure	Baseline, 5 Year
Secondary	EQ-5D-5L	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure	Baseline, 5 year
Secondary	VAS Pain Score	Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).	Baseline, 5 year
Secondary	American Knee Society Score	Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale.	Baseline, 5 year
Secondary	American Knee Society Score (surgeon evaluation)	Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation)	Baseline, 5 year
Secondary	Adverse Events	Evaluate type and frequency of Adverse Events	Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Secondary	Readmissions	Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).	6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Secondary	Survivorship	Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, 4 and 5 years.	1, 2, 3, 4 and 5 years
Secondary	Frequency of radiolucent line occurrence	Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs.	1, 2 and 5 years
Secondary	Anatomic Tibiofemoral Alignment	Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.	1, 2 and 5 years
Secondary	Femoral component alignment	Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.	1, 2 and 5 years
Secondary	Tibial component alignment	Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.	1, 2 and 5 years
Secondary	Restoration of joint line	Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.	First post-operative radiograph (1 day)