Clinical trial NCT05215678: Characteristics of Patients Declining INKA Trial Participation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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 characteristics.


Eligibility criteria: 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.

Primary outcomes:
measure: Oxford knee score
timeFrame: Baseline
Secondary outcomes:
measure: Health outcome and quality of life survey (EQ-5D-5L)
timeFrame: Baseline
measure: Analgesic use
timeFrame: Baseline
measure: The Knee Injury and Osteoarthritis Outcome Score - 12 item short form (KOOS-12)
timeFrame: Baseline
measure: Patient's global assessment of impact of the knee in daily life (PGA)
timeFrame: Baseline
measure: Body weight
timeFrame: Baseline
measure: Brief Illness perception questionnaire (B-IPQ)
timeFrame: Baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Søren Overgaard, DMSc
role: STUDY_CHAIR
References: