Knee Osteoarthritisn-INKANCT05215678
Characteristics of Patients Declining INKA Trial Participation
An observational study of Knee Osteoarthritis, run by Marius Henriksen at 1 site in Denmark.
Trial summary
The objective of this study is to compare baseline characteristics of overweight knee OA patients accepting vs. declining enrolment in the INKA trial (NCT05172843) to explore if enrolled patients differ systematically from the declining participants with respect to both measured as well as unmeasured baseline… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Acceptance of invitation to trial participation and Declining invitation to trial participation
- How many people
- 129 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 30 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients found eligible in INKA study (inclusion criteria for INKA (NCT05172843) and accepting and declining enrolment in the INKA study are invited to participate in our study. Study participants will be adults (i.e. at least 18 years old), have a diagnosis of knee osteoarthritis with an indication for primary knee arthroplasty (unicondylar or total arthroplasty), and be obese (BMI≥30 kg/m2).
Who may be able to join
- Age 18 or more
- A clinical and radiological diagnosis of knee OA
- BMI ≥ 30 kg/m2
- Motivated for weight loss as by the provided program
- Signed informed consent.
Who cannot join
- The scheduled surgery is for revision of an existing prosthesis
- Planned surgery for more than one knee within the observation period
- KA indication due to sequelae of fracture(s)
- Injection of medication or substances in the target knee within 3 months prior to participation
- Immuno-inflammatory arthritis as cause of the knee OA
- Current systemic treatment with glucocorticoids equivalent to > 7.5 mg of prednisolone/day
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- Previous or planned obesity surgery
- Inability to understand or read Danish incl. instructions and questionnaires
- Any other condition or impairment that, in the opinion of the investigator (or his/her delegate), makes a potential participant unsuitable for participation or which obstruct participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generalizability of Overweight Patients With Knee Osteoarthritis Awaiting Knee Surgery Accepting to Join a Weight Loss Randomized Trial: Protocol for a Cross-sectional Study Comparing Baseline Characteristics and Propensity of Patients Accepting/Declining Enrolment
The objective of this study is to compare baseline characteristics of overweight knee OA patients accepting vs. declining enrolment in the INKA trial (NCT05172843) to explore if enrolled patients differ systematically from the declining participants with respect to both measured as well as unmeasured baseline characteristics.
- Conditions
- Knee Osteoarthritis
- Being tested
- Acceptance of invitation to trial participation, Declining invitation to trial participation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance of invitation to trial participationOther
Individuals who are eligible for and accept participation in the INKA trial (NCT05172843)
Declining invitation to trial participationOther
Individuals who are eligible for participation in the INKA trial (NCT05172843) but decline the invitation to participate
| Study group | Role | What they receive |
|---|---|---|
| INKA participants | Individuals eligible and accepting participation in the INKA trial (NCT05172843) Receives: Other: Acceptance of invitation to trial participation | |
| n-INKA participants | Individuals eligible and declining participation in the INKA trial (NCT05172843) Receives: Other: Declining invitation to trial participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford knee score
The Oxford Knee Score (OKS) is a 12-item Patient Reported Outcome questionnaire developed specifically to assess the patient's perspective on the outcomes of knee arthroplasty (KA) with respect to combined pain and physical function. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Thus, a total score is calculated that ranges from 0 and 48, with 48 indicating the best outcome.
Measured: Baseline
Secondary outcomes (6)
Health outcome and quality of life survey (EQ-5D-5L)
EQ-5D-5L is a standardized patient-reported instrument for use as a measure of health outcome and quality of life. EQ-5D-5L is designed for self-completion by respondents and is ideally suited for use in surveys.
The EQ-5D-5L consists of a descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 1 to 3. It is simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.
The EQ-5D VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Measured: Baseline
Analgesic use
At clinical outcome assessment visit, the participants will be interviewed by an investigator about their use of analgesics since last visit. The interview will be focused on intake of
- Paracetamol/acetaminophen
- NSAIDS
- Acetylic acids
- Opioids The use of these analgesics will be recorded as a 0-3 points Likert scale (0, never; 1, rarely; 2, 2-3 times per week; 3, daily or almost daily).
Measured: Baseline
The Knee Injury and Osteoarthritis Outcome Score - 12 item short form (KOOS-12)
KOOS-12 provides scale scores for knee-specific Pain, Function and QOL, along with a summary measure of overall knee impact.
Each item is scored from 0 to 4, with 0 representing no knee problems and 4 representing extreme knee problems. The separate KOOS-12 Pain, Function and QOL scale scores are calculated, in which item responses are summed.
The KOOS-12 Summary knee impact score is calculated as the average of the KOOS-12 Pain, KOOS-12 Function and KOOS-12 QOL scale scores. A Summary impact score is not calculated if any of the three scale scores are missing. The KOOS-12 Summary impact score also ranges from 0 to 100, where 0 is the worst possible and 100 is the best possible score.
Measured: Baseline
Patient's global assessment of impact of the knee in daily life (PGA)
The participant's assessment of the impact of their knee on everyday life is measured as the response to the question "Taking into account all the activities you have during your daily life, your level of pain, and your functional impairment, how much does your [left/right] knee impact your daily life?". A 100 mm visual analogue scale (VAS) will be used as assessment instrument with anchors: 0 = "No impact" and 100 = "Worst imaginable impact".
Measured: Baseline
Body weight
The participants body weight is transferred from the medical records of their visit in the orthopaedic outpatient clinic.
Measured: Baseline
Brief Illness perception questionnaire (B-IPQ)
B-IPQ is a generic 9-item questionnaire developed to rapidly assess the cognitive and emotional representations in a variety of illnesses. B-IPQ is a short version of the 84-item revised illness perception questionnaire (IPQ-R) (21). B-IPQ assesses perceptions on the following five dimensions: Identity, Cause, Timeline, Consequences and Cure-Control. Five of the items assess cognitive illness representations; two of the items assess emotional representations; and one item assesses illness comprehensibility. The 8 items are scored on a 0-3 Likert scale with descriptors (none or extreme) at either end.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Feb 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Søren Overgaard, DMSc, Study chair, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215678
- Sponsor's protocol ID
- N-INKA
- Acronym
- n-INKA
- Status last verified
- Dec 2023
- First submitted
- 18 Jan 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision to share IPD with other researchers will be made at a later stage, including criteria for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalizability of Overweight Patients With Knee Osteoarthritis Awaiting Knee Surgery Accepting to Join a Weight Loss Randomized Trial: Protocol for a Cross-sectional Study Comparing Baseline Characteristics and Propensity of Patients Accepting/Declining Enrolment
- ClinicalTrials.gov ID
- NCT05215678
- Acronym / sponsor ID
- n-INKA / N-INKA
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 31 Jan 2022 (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 objective of this study is to compare baseline characteristics of overweight knee OA patients accepting vs. declining enrolment in the INKA trial (NCT05172843) to explore if enrolled patients differ systematically from the declining participants with respect to both measured as well as unmeasured baseline characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INKA participants | – | Other: Acceptance of invitation to trial participationIndividuals eligible and accepting participation in the INKA trial (NCT05172843) |
| n-INKA participants | – | Other: Declining invitation to trial participationIndividuals eligible and declining participation in the INKA trial (NCT05172843) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients found eligible in INKA study (inclusion criteria for INKA (NCT05172843) and accepting and declining enrolment in the INKA study are invited to participate in our study. Study participants will be adults (i.e. at least 18 years old), have a diagnosis of knee osteoarthritis with an indication for primary knee arthroplasty (unicondylar or total arthroplasty), and be obese (BMI≥30 kg/m2).
Key inclusion criteria (5 listed)
- Age 18 or more
- A clinical and radiological diagnosis of knee OA
- BMI ≥ 30 kg/m2
- Motivated for weight loss as by the provided program
- Signed informed consent.
Key exclusion criteria (9 listed)
- The scheduled surgery is for revision of an existing prosthesis
- Planned surgery for more than one knee within the observation period
- KA indication due to sequelae of fracture(s)
- Injection of medication or substances in the target knee within 3 months prior to participation
- Immuno-inflammatory arthritis as cause of the knee OA
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 |
|---|---|---|
| Acceptance of invitation to trial participationIndividuals who are eligible for and accept participation in the INKA trial (NCT05172843) | Other | INKA participants |
| Declining invitation to trial participationIndividuals who are eligible for participation in the INKA trial (NCT05172843) but decline the invitation to participate | Other | n-INKA participants |
Primary outcome
Oxford knee score
Time frame: Baseline
The Oxford Knee Score (OKS) is a 12-item Patient Reported Outcome questionnaire developed specifically to assess the patient's perspective on the outcomes of knee arthroplasty (KA) with respect to combined pain and physical function. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Thus, a total score is calculated that ranges from 0 and 48, with 48 indicating the best outcome.
6 secondary outcomes
Health outcome and quality of life survey (EQ-5D-5L)
Time frame: Baseline
Analgesic use
Time frame: Baseline
The Knee Injury and Osteoarthritis Outcome Score - 12 item short form (KOOS-12)
Time frame: Baseline
Patient's global assessment of impact of the knee in daily life (PGA)
Time frame: Baseline
Body weight
Time frame: Baseline
Brief Illness perception questionnaire (B-IPQ)
Time frame: Baseline
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 Dec 2023.
- Individual participant dataSharing planned: Undecided. Decision to share IPD with other researchers will be made at a later stage, including criteria for sharing.
Related trials for Knee Osteoarthritis
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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.
Søren Overgaard, DMSc study chair
University Hospital Bispebjerg and Frederiksberg
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 Marius Henriksen 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 5 inclusion and 9 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 Dec 2023. 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?
Oxford knee score (time frame: Baseline). 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 11 Dec 2023.