ArthritisNCT03058380
Stated-Preferences in Knee Arthroplasty
An observational study of Arthritis and Knee Osteoarthritis, run by Duke University at 1 site in United States.
Trial summary
The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Arthritis, Knee Osteoarthritis, Arthropathy of Knee
- What is being tested?
- Stated-Preferences Evaluation Instrument
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2017to 1 Jun 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopaedic Clinics, Adult Reconstructive Surgery Clinics
Who may be able to join
- Age 40-80
- Knee Pain
Who cannot join
- Inability to read, understand and give effective English consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)
The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.
- Conditions
- Arthritis, Knee Osteoarthritis, Arthropathy of Knee
- Being tested
- Stated-Preferences Evaluation Instrument
- Medical subject headings
- Arthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stated-Preferences Evaluation InstrumentOther
A discrete choice experiment (Stated-Preferences Evaluation Instrument) will be electronically configured using best practice stated-preference methods to quantify preferences for total knee replacement versus unicompartmental knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Stated-Preferences Evaluation Group | A stated-preferences evaluation instrument will be provided to participants with knee pain in the Stated-Preferences Evaluation Group. The instrument will measure patient preferences for total knee replacement versus unicompartmental knee replacement. Receives: Other: Stated-Preferences Evaluation Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference Measurements
Patient-stated preferences regarding treatment for knee pain based on questionnaires
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start17 Aug 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Richard C Mather III, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058380
- Sponsor's protocol ID
- Pro00079625
- Status last verified
- May 2019
- First submitted
- 16 Feb 2017
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT03058380
- Acronym / sponsor ID
- Pro00079625
- Conditions
- Arthritis, Knee Osteoarthritis, Arthropathy of Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Zimmer Biomet
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 20 Feb 2017 (actual)
- 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.
The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stated-Preferences Evaluation Group | – | Other: Stated-Preferences Evaluation InstrumentA stated-preferences evaluation instrument will be provided to participants with knee pain in the Stated-Preferences Evaluation Group. The instrument will measure patient preferences for total knee replacement versus unicompartmental knee replacement. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic Clinics, Adult Reconstructive Surgery Clinics
Key inclusion criteria (2 listed)
- Age 40-80
- Knee Pain
Key exclusion criteria (1 listed)
- Inability to read, understand and give effective English consent
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 |
|---|---|---|
| Stated-Preferences Evaluation InstrumentA discrete choice experiment (Stated-Preferences Evaluation Instrument) will be electronically configured using best practice stated-preference methods to quantify preferences for total knee replacement versus unicompartmental knee replacement surgery. | Other | Stated-Preferences Evaluation Group |
Primary outcome
Patient Preference Measurements
Time frame: 20 minutes
Patient-stated preferences regarding treatment for knee pain based on questionnaires
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 17 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Arthritis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Recruiting
Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingPhase 2
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Sjögren's Disease
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
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.
Richard C Mather III principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Knee Osteoarthritis, run by Duke University at 1 site in United States.
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 2 inclusion and 1 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Patient Preference Measurements (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2019.