10003 PRO Current Products

NCT01497730 | Completed

• 1 other identifier: 10003
• Study Type: observational
• Target: 842
• Locations: 4 countries
• Sites: 22

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 from different manufacturers will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the functional performance as measured by the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score (KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year post-operation. This will be carried out for all four implant configurations. The final endpoint is a 2-year evaluation.

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

  The primary endpoint will be measuerd before surgery and out to a minimum of 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.

  up to one year

Secondary Outcomes (5)

• Evaluate the psychometric properties of 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)

• Evaluate the longitudinal functional performance of primary TKA

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

• Evaluate Incidence of Anterior Knee Pain

  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)

• Evaluate incidence of asymptomatic and symptomatic crepitus

  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)

• Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees

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

Study Arms (4)

CR FB

Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration

Device: Total Knee Replacement

PS FB

Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration

Device: Total Knee Replacement

CR RP

Subjects receiving a Cruciate Retaining Rotating Platform implant configuration

Device: Total Knee Replacement

PS RP

Subjects receiving a Posterior Stabilized Rotating Platform implant configuration

Device: Total Knee Replacement

Interventions

Total Knee Replacement DEVICE

Subjects will receive one of the following total knee implants: PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.

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 with Non-inflammatory Degenerative Joint Disease (NIDJD) who require primary TKA with one of several designated knee systems currently on the market and are aged 22 to 80 years, inclusive.

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 this CIP with either a resurfaced or non-resurfaced patellae.
• Subject's TKA device was one of the total knee prostheses described under Interventions.
• Subject is currently not bedridden.
• Subject has given voluntary, written informed consent to participate in this clinical investigation, is willing and able to perform all study procedures and follow-up visits and has authorized the transfer of his/her information to DePuy.
• 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 English.
• 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 (22)

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

Orthopaedic Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Heekin Institute for Orthopedic Research

Jacksonville, Florida, 32205, United States

Location

The Arthroplasty Foundation

Louisville, Kentucky, 40215, United States

Location

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, 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, 03756, United States

Location

Cardinal Orthopaedic Institute

Columbus, Ohio, 43213, United States

Location

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22307-9804, United States

Location

Swedish Orthopedic Institute

Seattle, Washington, 98122-5330, United States

Location

Hornsby Ku-ring-gai Hospital

Hornsby, New South Wales, 2077, Australia

Location

Wakefield Orthopedic Clinic

Adelaide, South Australia, 5000, Australia

Location

Freemantle Hospital

Crawley, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, 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

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

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 20, 2011
• First Posted: December 22, 2011
• Study Start: October 1, 2011
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

US (11); AU (4); GB (6); NZ (1)