Characteristics of Patients Declining INKA Trial Participation (n-INKA)

Marius Henriksen

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Declining invitation to trial participation; Other: Acceptance of invitation to trial participation

Study type: Observational

Funder types: Other

Identifiers

NCT05215678

N-INKA

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

129 participants in 2 patient groups

INKA participants

Description:

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

Treatment:

Other: Acceptance of invitation to trial participation

n-INKA participants

Description:

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

Treatment:

Other: Declining invitation to trial participation