Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance (10003)

This study is currently recruiting participants.
Verified December 2013 by DePuy Orthopaedics
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01497730
First received: December 20, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Noninflammatory Degenerative Joint Disease
Device: Total Knee Replacement

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Evaluate the psychometric properties of PKIP [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The Pre and Post-Surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.

  • Evaluate the longitudinal functional performance of primary TKA [ Time Frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]
  • Evaluate Incidence of Anterior Knee Pain [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Evaluate incidence of asymptomatic and symptomatic crepitus [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees [ Time Frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total Knee Replacement

Subjects will receive one of the following total knee implants:

  • fixed bearing cruciate retaining (FB CR)
  • fixed bearing posterior stabilized (FB PS)
  • rotating platform cruciate retaining (RP CR)
  • rotating platform posterior stabilized (RP PS)
Device: Total Knee Replacement

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.


Detailed Description:

The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 840 patients (840 knees). Each study site is expected to enroll approximately 42 patients (42 knees). Cohort reallocation is permitted. There will be no control group. Eight hundred forty (840) Subjects will be stratified into 4 subgroups of 210: fixed bearing cruciate retaining (FB CR), fixed bearing posterior stabilized (FB PS), rotating platform cruciate retaining (RP CR), and rotating platform posterior stabilized (RP PS).

Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

  Eligibility

Ages Eligible for Study:   22 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497730

Contacts
Contact: Sam Himden, BS 574-372-7231 SHimden@its.jnj.com

Locations
United States, California
Orthopaedic Specialty Institute Recruiting
Orange, California, United States, 92868
United States, Colorado
Orthopaedic Center of the Rockies Recruiting
Fort Collins, Colorado, United States, 80525
United States, Florida
Heekin Institute for Orthopedic Research Active, not recruiting
Jacksonville, Florida, United States, 32204
United States, Kentucky
The Arthroplasty Foundation Not yet recruiting
Louisville, Kentucky, United States, 40215
United States, New Hampshire
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Cardinal Orthopaedic Institute Recruiting
Columbus, Ohio, United States, 43213
United States, Virginia
Anderson Orthopaedic Research Institute Not yet recruiting
Alexandria, Virginia, United States, 22307-9804
United States, Washington
Swedish Orthopedic Institute Recruiting
Seattle, Washington, United States, 98122-5330
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Sam Himden, BS DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01497730     History of Changes
Other Study ID Numbers: 10003
Study First Received: December 20, 2011
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:
Arthroplasty, Replacement, Knee,

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014