Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System

NCT01746524 | Completed

• 1 other identifier: 10004
• Study Type: observational
• Target: 1,138
• Locations: 4 countries
• Sites: 20

Brief Summary

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).

Conditions

Osteoarthritis

Keywords

Arthroplasty; Replacement; Knee

Outcome Measures

Primary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.

  The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. 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. The change from baseline is the minimum 1 year (approximately 304 to 668 days) measurement minus the baseline measurement.

  One year or later (approximately 304 days or later)

Secondary Outcomes (11)

• Patient Reported Outcome: Oxford Knee Score (OKS)

  Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

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

  Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

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

  Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

• Type and Frequency of Adverse Events (AEs) for all enrolled subjects

  < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

• Evaluate primary cemented fixation through zonal radiographic analysis post-operatively

  minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

Study Arms (4)

CR FB

Subjects receiving Cruciate Retaining Fixed Bearing configuration of ATTUNE Primary Knee Implant

Device: ATTUNE Primary Total Knee Arthroplasty

PS FB

Subjects receiving Posterior Stabilized Fixed Bearing configuration of ATTUNE Primary Knee Implant

Device: ATTUNE Primary Total Knee Arthroplasty

CR RP

Subjects receiving Cruciate Retaining Rotating Platform configuration of ATTUNE Primary Knee Implant

Device: ATTUNE Primary Total Knee Arthroplasty

PS RP

Subjects receiving Posterior Stabilized Rotating Platform configuration of ATTUNE Primary Knee Implant

Device: ATTUNE Primary Total Knee Arthroplasty

Interventions

ATTUNE Primary Total Knee Arthroplasty DEVICE

Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).

CR FB; CR RP; PS FB; PS RP

Eligibility Criteria

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

Study Population

Male and female Subjects, age 22-80 years, inclusive, with Non-inflammatory Degenerative Joint Disease (NIDJD) who are suitable candidates for primary TKA using the Attune system.

You may qualify if:

• Subject is male or female and between the ages of 22 and 80 years, inclusive.
• Subject was diagnosed with NIDJD.
• Subject is a suitable candidate for cemented primary TKA using the devices described in the Clinical Investigation Plan (CIP)with either resurfaced or non-resurfaced patellae.
• Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
• Subject is currently not bedridden.
• Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
• Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
• The devices specified in this CIP were implanted.

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 experiencing radicular pain from the spine.
• Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
• Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
• Subject has significant neurological or musculoskeletal disorders 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 is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
• Subject has a medical condition with less than 2 years of life expectancy.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (20)

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

Orhopaedic Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

The Arthroplasty Foundation

Louisville, Kentucky, 40215, United States

Location

Hip and Knee Research of Nevada

Las Vegas, Nevada, 89128, United States

Location

Dartmouth Medical School/Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03765, United States

Location

Cardinal Orthopaedic Institute

Columbus, Ohio, 43213, United States

Location

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22307, United States

Location

Swedish Orthopedic Institute

Seattle, Washington, 98122, United States

Location

Sutherland Hospital

Caringbah, New South Wales, 2229, Australia

Location

Hornsby Ku-ring-gai Hospital

Hornsby, New South Wales, 2077, Australia

Location

Wakefield Orthopaedic Clinic

Adelaide, South Australia, 5000, Australia

Location

Freemantle Hospital

Crawley, Western Australia, 6009, Australia

Location

Ascot Hospital

Auckland, New Zealand

Location

Queen Margaret Hospital

Dunfermline, Fife, KY12 OSU, United Kingdom

Location

The Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Princess Alexandra Hospital

Harlow, CM20 1QX, United Kingdom

Location

University Hospital Llandough

Llandough, CF64 2XX, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Clifton Park NHS Treatment Centre

York, YO30 5RA, United Kingdom

Location

Related Publications (1)

• Hamilton WG, Brenkel IJ, Barnett SL, Allen PW, Dwyer KA, Lesko JP, Kantor SR, Clatworthy MG. Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study. J Am Acad Orthop Surg Glob Res Rev. 2021 Dec 15;5(12):e21.00136. doi: 10.5435/JAAOSGlobal-D-21-00136.

  PMID: 34908561 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ahmad S, Ismail, MS, CCRP

  DePuy Orthopaedics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 11, 2012
• Study Start: November 1, 2012
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

US (9); NZ (1); AU (4); GB (6)