Osteoarthritis10003NCT01497730
10003 PRO Current Products
An observational study of Osteoarthritis, run by DePuy Orthopaedics at 22 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Knee Replacement
- Type of treatment
- Medical device
- How many people
- 842 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 1 Oct 2011to 10 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States11 sites
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22307-9804
Cardinal Orthopaedic Institute
Columbus, Ohio, 43213
Orthopaedic Center of the Rockies
Fort Collins, Colorado, 80525
Heekin Institute for Orthopedic Research
Jacksonville, Florida, 32205
Hip and Knee Research of Nevada
Las Vegas, Nevada, 89128
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The Arthroplasty Foundation
Louisville, Kentucky, 40215
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Orthopaedic Specialty Institute
Orange, California, 92868
UCSD Medical Center
San Diego, California, 92103
Swedish Orthopedic Institute
Seattle, Washington, 98122-5330
United Kingdom6 sites
Queen Margaret Hospital
Dunfermline, Fife, KY12 OSU
The Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
Princess Alexandra Hospital
Harlow, CM20 1QX
University Hospital Llandough
Llandough, CF64 2XX
James Cook University Hospital
Middlesbrough, TS4 3BW
Clifton Park NHS Treatment Centre
York, YO30 5RA
Australia4 sites
Wakefield Orthopedic Clinic
Adelaide, South Australia, 5000
Freemantle Hospital
Crawley, Western Australia, 6009
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, 2077
Royal Perth Hospital
Perth, Western Australia, 6000
About this study
Official title: Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Total Knee Replacement
- Keywords
- Arthroplasty, Replacement, Knee,
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ReplacementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CR FB | Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration Receives: Device: Total Knee Replacement | |
| PS FB | Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration Receives: Device: Total Knee Replacement | |
| CR RP | Subjects receiving a Cruciate Retaining Rotating Platform implant configuration Receives: Device: Total Knee Replacement | |
| PS RP | Subjects receiving a Posterior Stabilized Rotating Platform implant configuration Receives: Device: Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one year
Secondary outcomes (5)
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.
Measured: 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
Measured: < 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
Measured: 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
Measured: 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
Measured: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study start1 Oct 2011
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmad S. Ismail, MS, CCRP, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497730
- Sponsor's protocol ID
- 10003
- Acronym
- 10003
- Status last verified
- Apr 2019
- First submitted
- 20 Dec 2011
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34908561
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance
- ClinicalTrials.gov ID
- NCT01497730
- Acronym / sponsor ID
- 10003 / 10003
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CR FB | – | Device: Total Knee ReplacementSubjects receiving a Cruciate Retaining Fixed Bearing implant configuration |
| PS FB | – | Device: Total Knee ReplacementSubjects Receiving a Posterior Stabilized Fixed Bearing implant configuration |
| CR RP | – | Device: Total Knee ReplacementSubjects receiving a Cruciate Retaining Rotating Platform implant configuration |
| PS RP | – | Device: Total Knee ReplacementSubjects receiving a Posterior Stabilized Rotating Platform implant configuration |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ReplacementSubjects 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. | Device | CR FB, CR RP, PS FB, PS RP |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score
Time frame: up to one year
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Derived from this study: PubMed 34908561Hamilton 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.
Related trials for Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad S. Ismail, MS, CCRP study director
DePuy Orthopaedics
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by DePuy Orthopaedics at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.