Knee OsteoarthritisNCT02091830
Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients
An observational study of Knee Osteoarthritis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Paracetamol and nonsteroidal antiinflammatory drug (NSAID), Physiotherapy and Cortisone Injection
- Type of treatment
- Injection or infusion
- How many people
- 2,262 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jul 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 2200 patients with knee osteoarthritis not eligible for at total knee arthroplasty
Who may be able to join
- Not eligible for at total knee arthroplasty
Who cannot join
- Ipsilateral knee arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments).
The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.
- Conditions
- Knee Osteoarthritis
- Being tested
- Paracetamol and nonsteroidal antiinflammatory drug (NSAID), Physiotherapy, Cortisone Injection, Others
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol and nonsteroidal antiinflammatory drug (NSAID)Drug
PhysiotherapyOther
Cortisone InjectionDrug
OthersOther
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical treatment | Not described Receives: Drug: Paracetamol and nonsteroidal antiinflammatory drug (NSAID); Other: Physiotherapy; Drug: Cortisone Injection; Other: Others |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported improvement
Assessed using the question:
Has your pain improved? Response categories: pain free; better; unchanged; worse
Measured: 2-5 years after consulting orthopedic surgeon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Retrospective
- Enrolment
- 2,262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Simonsen, Northern Orthopaedic Division, Denmark
- Investigators
- Michael Rathleff, MSc, Study chair, Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Denmark.Mikkel M Andersen, MSc, Study chair, Department of Mathematical Sciences, Aalborg UniversityOle Simonsen, MD, DMSc, Principal investigator, Department of Orthopedic SurgeryChristina A Derosche, BSc, Study chair, Department of Orthopedic SurgerySigne B Pedersen, Study chair, Department of Orthopedic SurgerySøren T Skou, MSc, Study chair, Orthopedic Surgery Research Unit + Department of Health Science and Technology, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091830
- Sponsor's protocol ID
- The 07 - 11 cohort
- Status last verified
- Oct 2015
- First submitted
- 18 Mar 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients
- ClinicalTrials.gov ID
- NCT02091830
- Acronym / sponsor ID
- The 07 - 11 cohort
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,262 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Mar 2014 (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 purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments).
The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical treatment | – | Drug: Paracetamol and nonsteroidal antiinflammatory drug (NSAID), Other: Physiotherapy, Drug: Cortisone Injection, Other: Others |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2200 patients with knee osteoarthritis not eligible for at total knee arthroplasty
Key inclusion criteria (1 listed)
- Not eligible for at total knee arthroplasty
Key exclusion criteria (1 listed)
- Ipsilateral knee arthroplasty
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 |
|---|---|---|
| Paracetamol and nonsteroidal antiinflammatory drug (NSAID) | Drug | Non-surgical treatment |
| Physiotherapy | Other | Non-surgical treatment |
| Cortisone Injection | Drug | Non-surgical treatment |
| Others | Other | Non-surgical treatment |
Primary outcome
Self-reported improvement
Time frame: 2-5 years after consulting orthopedic surgeon
Assessed using the question: Has your pain improved? Response categories: pain free; better; unchanged; worse
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 20 Oct 2015.
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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.
Michael Rathleff, MSc study chair
Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Denmark.
Mikkel M Andersen, MSc study chair
Department of Mathematical Sciences, Aalborg University
Ole Simonsen, MD, DMSc principal investigator
Department of Orthopedic Surgery
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 Knee Osteoarthritis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 1 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 20 Oct 2015. 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 Denmark. 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?
Self-reported improvement (time frame: 2-5 years after consulting orthopedic surgeon). 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 20 Oct 2015.