Characteristics of Patients Declining INKA Trial Participation

NCT05215678 | Completed

• 1 other identifier: N-INKA
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (6)

• Health outcome and quality of life survey (EQ-5D-5L)

  Baseline

• Analgesic use

  Baseline

• The Knee Injury and Osteoarthritis Outcome Score - 12 item short form (KOOS-12)

  Baseline

• Patient's global assessment of impact of the knee in daily life (PGA)

  Baseline

• Body weight

  Baseline

Study Arms (2)

INKA participants

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

Other: Acceptance of invitation to trial participation

n-INKA participants

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

Other: Declining invitation to trial participation

Interventions

Acceptance of invitation to trial participation OTHER

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

INKA participants

Declining invitation to trial participation OTHER

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

n-INKA participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Søren Overgaard, DMSc

  University Hospital Bispebjerg and Frederiksberg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: February 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

DK (1)