Osteoarthritis of the KneeNCT02934672
KineSpring® System Patient Preference Study
An observational study of Osteoarthritis of the Knee, run by Moximed.
Trial summary
The primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Survey
- How many people
- 323 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females aged 25 to 80 years old diagnosed with osteoarthritis in the knee
Who may be able to join
- Males and females aged 25 - 80 years
- Diagnosed with osteoarthritis in the knee
- Experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful
- Experience knee pain at least once a week
- Previously failed non-surgical treatments for knee OA pain
- Pass a security screen
Who cannot join
- Do not suffer or has not been diagnosed with knee osteoarthritis
- Has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)
About this study
The primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System.
Read the detailed description
Well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Survey
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Internet panelists, who self-reported that they or another adult in their household has osteoarthritis, were sent an email invitation to the survey site.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preferences for knee osteoarthritis surgical procedures
Patient preference for knee osteoarthritis surgeries
Measured: At time of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
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 Osteoarthritis of the KneeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moximed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tessa Yamut, Study director, Moximed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934672
- Sponsor's protocol ID
- 102392
- Status last verified
- Mar 2019
- First submitted
- 13 Oct 2016
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moorman CT 3rd, Kirwan T, Share J, Vannabouathong C. Patient Preferences Regarding Surgical Interventions for Knee Osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Sep 20;10:1179544117732039. doi: 10.1177/1179544117732039. eCollection 2017.
PubMed 28974919
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KineSpring® System Patient Preference Study
- ClinicalTrials.gov ID
- NCT02934672
- Acronym / sponsor ID
- 102392
- Conditions
- Osteoarthritis of the Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- MoximedIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Oct 2016 (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.
The primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System.
Detailed description
Well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females aged 25 to 80 years old diagnosed with osteoarthritis in the knee
Key inclusion criteria (6 listed)
- Males and females aged 25 - 80 years
- Diagnosed with osteoarthritis in the knee
- Experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful
- Experience knee pain at least once a week
- Previously failed non-surgical treatments for knee OA pain
Key exclusion criteria (2 listed)
- Do not suffer or has not been diagnosed with knee osteoarthritis
- Has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)
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 |
|---|---|---|
| SurveyInternet panelists, who self-reported that they or another adult in their household has osteoarthritis, were sent an email invitation to the survey site. | Other | – |
Primary outcome
Patient preferences for knee osteoarthritis surgical procedures
Time frame: At time of survey
Patient preference for knee osteoarthritis surgeries
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 Mar 2019.
- Results publication: PubMed 28974919Moorman CT 3rd, Kirwan T, Share J, Vannabouathong C. Patient Preferences Regarding Surgical Interventions for Knee Osteoarthritis. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Sep 20;10:1179544117732039. doi: 10.1177/1179544117732039. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
Tessa Yamut study director
Moximed
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Knee, run by Moximed.
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 6 inclusion and 2 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 preferences for knee osteoarthritis surgical procedures (time frame: At time of survey). 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 NCT02934672, 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 Mar 2019.