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Characteristics of Patients Declining INKA Trial Participation

NCT ID: NCT05215678

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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INKA participants

Individuals eligible and accepting participation in the INKA trial (NCT05172843)

Acceptance of invitation to trial participation

Intervention Type OTHER

Individuals who are eligible for and accept participation in the INKA trial (NCT05172843)

n-INKA participants

Individuals eligible and declining participation in the INKA trial (NCT05172843)

Declining invitation to trial participation

Intervention Type OTHER

Individuals who are eligible for participation in the INKA trial (NCT05172843) but decline the invitation to participate

Interventions

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Acceptance of invitation to trial participation

Individuals who are eligible for and accept participation in the INKA trial (NCT05172843)

Intervention Type OTHER

Declining invitation to trial participation

Individuals who are eligible for participation in the INKA trial (NCT05172843) but decline the invitation to participate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or more
2. A clinical and radiological diagnosis of knee OA
3. BMI ≥ 30 kg/m2
4. Motivated for weight loss as by the provided program
5. Signed informed consent.

Exclusion Criteria

1. The scheduled surgery is for revision of an existing prosthesis
2. Planned surgery for more than one knee within the observation period
3. KA indication due to sequelae of fracture(s)
4. Injection of medication or substances in the target knee within 3 months prior to participation
5. Immuno-inflammatory arthritis as cause of the knee OA
6. Current systemic treatment with glucocorticoids equivalent to \> 7.5 mg of prednisolone/day
7. Previous or planned obesity surgery
8. Inability to understand or read Danish incl. instructions and questionnaires
9. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marius Henriksen

OTHER

Sponsor Role lead

Responsible Party

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Marius Henriksen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Søren Overgaard, DMSc

Role: STUDY_CHAIR

University Hospital Bispebjerg and Frederiksberg

Locations

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The Parker Institute, Frederiksberg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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N-INKA

Identifier Type: -

Identifier Source: org_study_id