Osteoarthritis10004NCT01746524
Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
An observational study of Osteoarthritis, run by DePuy Orthopaedics at 20 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 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?
- ATTUNE Primary Total Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 1,138 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 1 Nov 2012to 5 Mar 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, age 22-80 years, inclusive, with Non-inflammatory Degenerative Joint Disease (NIDJD) who are suitable candidates for primary TKA using the Attune system.
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 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.
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
20 sites in 4 countries.
20 sites in 4 countries
United States9 sites
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22307
Cardinal Orthopaedic Institute
Columbus, Ohio, 43213
Orhopaedic Center of the Rockies
Fort Collins, Colorado, 80525
Hip and Knee Research of Nevada
Las Vegas, Nevada, 89128
Dartmouth Medical School/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03765
The Arthroplasty Foundation
Louisville, Kentucky, 40215
Orthopaedic Specialty Institute
Orange, California, 92868
UCSD Medical Center
San Diego, California, 92103
Swedish Orthopedic Institute
Seattle, Washington, 98122
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 Orthopaedic Clinic
Adelaide, South Australia, 5000
Sutherland Hospital
Caringbah, New South Wales, 2229
Freemantle Hospital
Crawley, Western Australia, 6009
Hornsby Ku-ring-gai Hospital
Hornsby, New South Wales, 2077
About this study
Official title: Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
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).
Read the detailed description
The study is designed as a prospective, single arm stratified, multi-center investigation.
Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There will be no control group. One thousand and forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating platform (CR RP), and posterior stabilized rotating platform (PS RP). 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
- ATTUNE Primary Total Knee Arthroplasty
- 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.
ATTUNE Primary Total Knee ArthroplastyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| CR FB | Subjects receiving Cruciate Retaining Fixed Bearing configuration of ATTUNE Primary Knee Implant Receives: Device: ATTUNE Primary Total Knee Arthroplasty | |
| PS FB | Subjects receiving Posterior Stabilized Fixed Bearing configuration of ATTUNE Primary Knee Implant Receives: Device: ATTUNE Primary Total Knee Arthroplasty | |
| CR RP | Subjects receiving Cruciate Retaining Rotating Platform configuration of ATTUNE Primary Knee Implant Receives: Device: ATTUNE Primary Total Knee Arthroplasty | |
| PS RP | Subjects receiving Posterior Stabilized Rotating Platform configuration of ATTUNE Primary Knee Implant Receives: Device: ATTUNE Primary Total Knee Arthroplasty |
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 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.
Measured: One year or later (approximately 304 days or later)
Secondary outcomes (11)
Patient Reported Outcome: Oxford Knee Score (OKS)
The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having 5 Likert- like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.
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)
Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
The Pre Surgical and/or 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)
Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
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)
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
Measured: < 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
Radiographs will be reviewed by an independent radiographic reviewer (IRR). Data from the IRR radiographic evaluations will be used for determination of radiographic success criteria.
Measured: minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus
The Anterior Knee Pain and Crepitus questionnaire will be used. It is a 2 part questionnaire that is patient-self administered. The crepitus questions include frequency of crepitus and whether or not crepitus is symptomatic. The anterior knee pain contains 2 questions that collect frequency of pain and location of 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 surgeon learning curve on clinical and functional outcomes
Each surgeon will implant devices into the first 10 Subjects which will be considered as 'learning curve cases'; these learning curve cases will not be pooled with post-learning curve cases unless learning curve analyses indicate that there is not a significant learning curve with regard to clinical or functional Subject outcomes.
Measured: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate the impact of ligament balancing surgical technique on functional performance
Description of the Subject's surgical procedure including such items as surgical approach and ligament balancing will be evaluated.
Measured: Operatively (Day 0 - Date of Surgery)
Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
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 functional outcome of patella resurfacing and non-resurfacing
An exploratory comparison of results between knees with patella resurfacing versus knees without resurfacing will be conducted. A comparison of KOOS, PKIP, OKS, Knee Society (AKS), anterior knee pain incidence, and crepitus will be conducted.
Measured: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate changes in femoral component and tibial component alignment
Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
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 posted11 Dec 2012 (estimated)
- Study start1 Nov 2012
- Primary completion5 Mar 2018
- Study completion5 Mar 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
- 1,138 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
- NCT01746524
- Sponsor's protocol ID
- 10004
- Acronym
- 10004
- Status last verified
- Apr 2019
- First submitted
- 5 Dec 2012
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- 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 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
- ClinicalTrials.gov ID
- NCT01746524
- Acronym / sponsor ID
- 10004 / 10004
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,138 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 11 Dec 2012 (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 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).
Detailed description
The study is designed as a prospective, single arm stratified, multi-center investigation.
Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There will be no control group. One thousand and forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating platform (CR RP), and posterior stabilized rotating platform (PS RP). 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: ATTUNE Primary Total Knee ArthroplastySubjects receiving Cruciate Retaining Fixed Bearing configuration of ATTUNE Primary Knee Implant |
| PS FB | – | Device: ATTUNE Primary Total Knee ArthroplastySubjects receiving Posterior Stabilized Fixed Bearing configuration of ATTUNE Primary Knee Implant |
| CR RP | – | Device: ATTUNE Primary Total Knee ArthroplastySubjects receiving Cruciate Retaining Rotating Platform configuration of ATTUNE Primary Knee Implant |
| PS RP | – | Device: ATTUNE Primary Total Knee ArthroplastySubjects receiving Posterior Stabilized Rotating Platform configuration of ATTUNE Primary Knee Implant |
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, age 22-80 years, inclusive, with Non-inflammatory Degenerative Joint Disease (NIDJD) who are suitable candidates for primary TKA using the Attune system.
Key inclusion criteria (8 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 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.
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 |
|---|---|---|
| ATTUNE Primary Total Knee ArthroplastyPatients 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). | 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 change from baseline.
Time frame: One year or later (approximately 304 days or later)
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.
11 secondary outcomes
Patient Reported Outcome: Oxford Knee Score (OKS)
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)
Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (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)
Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
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)
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Time frame: < 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
Time frame: minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Incidence of post-operative anterior knee pain and symptomatic/asymptomatic 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 surgeon learning curve on clinical and functional outcomes
Time frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate the impact of ligament balancing surgical technique on functional performance
Time frame: Operatively (Day 0 - Date of Surgery)
Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
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 functional outcome of patella resurfacing and non-resurfacing
Time frame: < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Evaluate changes in femoral component and tibial component alignment
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 11 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.
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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
20 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 20 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 8 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 11 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 20 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 change from baseline. (time frame: One year or later (approximately 304 days or later)). 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 NCT01746524, 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 11 Apr 2019.