ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Revision Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03153475
• Other study ID #: DSJ-2016-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: March 31, 2029

Study information

• Verified date: June 2024
• Source: DePuy Orthopaedics
• Contact: n/a
• 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 revision total knee arthroplasty.

Description:

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.

The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.

Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: March 31, 2029
• Est. primary completion date: March 31, 2029
• 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. Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components.

3. The decision to perform a knee revision with the study device is regardless of the research.

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

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

2. Contralateral knee has already been enrolled in this study.

3. Subject had a contralateral amputation.

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

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

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

7. 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.

8. 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.

9. 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).

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

11. Uncontrolled gout

Related Conditions & MeSH terms

• Revision Total Knee Arthroplasty

Intervention

Device:
• ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.

Locations

Country	Name	City	State
Australia	The Gold Coast Centre for Bone and Joint Surgery	Gold Coast
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	CHRU La Cavale Blanche	Brest
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	CLINICHE GAVAZZENI SPA aka Humanitas Castelli	Bergamo
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	North Yorkshire
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	Survivorship	To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.	5 Years
Secondary	Patient's Knee Implant Performance (PKIP)	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores)	Baseline, 2 and 5 yr timepoints
Secondary	Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures	Baseline, 2 year and 5 Year
Secondary	American Knee Society Score	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure	Baseline, 2 year, 5 year
Secondary	EQ-5D-5L	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures	Baseline, 2 year and 5 year
Secondary	VAS Pain Score	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).	Baseline, 2 year and 5 year
Secondary	Patient Satisfaction	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.	Baseline, 2 year and 5 year
Secondary	Adverse Events	Evaluate type and frequency of Adverse Events	Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
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 yrs., 3 yrs., 4 yrs., 5 yrs
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, and 4 years.	1, 2, 3 and 4 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)