10003 PRO Current Products

Osteoarthritis Clinical Trial

— 10003  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497730
• Other study ID #: 10003
• Status: Completed
• Start date: October 1, 2011
• Est. completion date: August 10, 2018

Study information

• Verified date: April 2019
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 842
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Australia	Wakefield Orthopedic Clinic	Adelaide	South Australia
Australia	Freemantle Hospital	Crawley	Western Australia
Australia	Hornsby Ku-ring-gai Hospital	Hornsby	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
New Zealand	Ascot Hospital	Auckland
United Kingdom	Queen Margaret Hospital	Dunfermline	Fife
United Kingdom	The Royal Surrey County Hospital	Guildford	Surrey
United Kingdom	Princess Alexandra Hospital	Harlow
United Kingdom	University Hospital Llandough	Llandough
United Kingdom	James Cook University Hospital	Middlesborough
United Kingdom	Clifton Park NHS Treatment Centre	York
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia
United States	Cardinal Orthopaedic Institute	Columbus	Ohio
United States	Orthopaedic Center of the Rockies	Fort Collins	Colorado
United States	Heekin Institute for Orthopedic Research	Jacksonville	Florida
United States	Hip and Knee Research of Nevada	Las Vegas	Nevada
United States	Dartmouth Medical School/Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	The Arthroplasty Foundation	Louisville	Kentucky
United States	Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Orthopaedic Specialty Institute	Orange	California
United States	UCSD Medical Center	San Diego	California
United States	Swedish Orthopedic Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the psychometric properties of PKIP	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.	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)