A Multidisciplinary Intervention in Total Knee Arthroplasty

• Register: ClinicalTrials.gov
• Last refreshed on: 30 January 2023
• Main ID: NCT03771430
• Date of registration: 12/11/2018
• Prospective Registration: Yes
• Primary sponsor: Lovisenberg Diakonale Hospital
• Public title: A Multidisciplinary Intervention in Total Knee Arthroplasty MultiKnee
• Scientific title: A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)
• Date of first enrolment: August 28, 2019
• Target sample size: 282
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03771430
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Maren F Lindberg, PhD
• Affiliation: Lovisenberg Diakonale Hospital/University of Oslo

• Name: Maren Falch Lindberg, PhD

• Name: Kari Indrekvam, PhD
• Affiliation: Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen

• Name: Arild Aamodt, PhD
• Affiliation: Lovisenberg Diakonale Hospital

• Name: Anners Lerdal, PhD
• Affiliation: Lovisenberg Diaconal Hospital, University of Oslo

• Name: Stig Heir, PhD
• Affiliation: Martina Hansens Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Scheduled for TKA for OA at Lovisenberg, Oslo; Martina Hansen, Bærum, or Coastal
Hospital Hagevik, Bergen

2. Age 18 - 79 years

3. ASA grade 1-3

4. KL grade 3 or 4

5. BMI<40

6. Able to read and write in Norwegian

Exclusion Criteria:

- Diagnosis of dementia or sero-positive rheumatic disease

- Previously undergone uni or patellofemoral prosthesis in the index knee

- Large axis deviation or instability requiring use of hinged implants

- Scheduled for unicompartmental arthroplasty or revision surgery



Age minimum: 18 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis; Primary

Degenerative Joint Disease of Knee

Intervention(s)

Behavioral: Osteoarthritis education, exercise and CBT

Procedure: Total Knee Arthroplasty

Primary Outcome(s)

Change in the knee injury and osteoarthritis score (KOOS) pain subscale [Time Frame: Before randomization, 12 months after treatment start. Also measured at 3, 6, and 24 months after treatment start.12 months after treatment start will be the primary outcome.]

Secondary Outcome(s)

EuroQol-5D-5L [Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start]

The Forgotten Joint Score [Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start]

Brief Pain inventory [Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start]

Pain Catastrophizing Scale [Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start]

Patient-acceptable symptom state, perceived treatment failure. [Time Frame: At 3, 6, 12 and 24 months following treatment start.]

Knee injury and osteoarthritis score (KOOS) subscores: Other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL) [Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start]

Adverse events/serious adverse events [Time Frame: From treatment start until 24 months following treatment start.]

Global perceived effect [Time Frame: At 3, 6, 12 and 24 months following treatment start.]

The 30 second sit to stand test [Time Frame: Before treatment start. 3, 6, 12 and 24 months following treatment start]

Secondary ID(s)

MultiKnee Trial

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Martina Hansen's Hospital

Haukeland University Hospital