14022 ATTUNE Cementless RP Clinical Performance Evaluation

NCT02839850 | Active Not Recruiting FDA Device

• 1 other identifier: 14022
• Study Type: interventional
• Target: 540
• Locations: 9 countries
• Sites: 20

Brief Summary

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).

Conditions

Osteoarthritis

Keywords

Arthroplasty; replacement; Knee; function; radiographic; survivorship

Outcome Measures

Primary Outcomes (1)

• Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)

  The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Minimum 2 years (670-1033 days after surgery)

Secondary Outcomes (13)

• Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)

  Minimum 2 years (670-1033 days after surgery)

• Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Minimum 2 years (670-1033 days after surgery)

• Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011

  Minimum 2 years (670-1033 days after surgery)

• Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)

  Minimum 2 years (670-1033 days after surgery)

• Modified VAS Pain Score: Pain and Satisfaction

  Minimum 2 years (670-1033 days after surgery)

Study Arms (1)

ATTUNE Cementless RP TKA

EXPERIMENTAL

Subjects will receive a cementless, rotating platform total knee arthroplasty

Device: Cementless Total Knee Arthroplasty

Interventions

Cementless Total Knee Arthroplasty DEVICE

Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)

ATTUNE Cementless RP TKA

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
• Subject was diagnosed with NIDJD.
• Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
• 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
• Subject is currently not bedridden
• 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.
• 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.

You may not qualify if:

• The Subject is a woman who is pregnant or lactating.
• Contralateral knee has already been enrolled in this study .
• Subject had a contralateral amputation.
• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
• Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
• Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• 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 their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
• 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.
• Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
• Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
• Subject has a medical condition with less than five (5) years life expectancy.
• Uncontrolled gout

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (20)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Florida Research Associates

DeLand, Florida, 32720, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New London Hospital

New London, New Hampshire, 03257, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

SUNY downstate Medical Center

Brooklyn, New York, 11203, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Associated Orthopaedics of Kingsport

Kingsport, Tennessee, 37660, United States

Location

Texas Tech University Heath Science Center

Lubbock, Texas, 49416, United States

Location

Hampton Roads Orthopaedics and Sports Medicine

Newport News, Virginia, 23606, United States

Location

Krankenhaus der Barmherzigen Schwestern Ried im Innkreis

Ried im Innkreis, Upper Austria, 4910, Austria

Location

Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

CHU de la Cavale Blanche

Brest, Cedex, 29285, France

Location

Sevice de Chirurgie Orthoedique et Traumatologique

Salouël, 80480, France

Location

Klinikum Garmisch-Partenkirchen GmbH

Garmisch-Partenkirchen, 82467, Germany

Location

South Infirmary Victoria University Hospital

Cork, T12 X23H, Ireland

Location

Elkerliek Ziekenhuis

Helmond, North Brabant, 5707 HA, Netherlands

Location

University of Otago

Christchurch, 8083, New Zealand

Location

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sukhjeet Kaur

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An independent radiographic reviewer will be assessing all radiographs from the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NZ (1); CA (1); US (10); DE (1); NL (1); GB (2); FR (2); IE (1)