A Multidisciplinary Intervention in Total Knee Arthroplasty (MultiKnee)

Lovisenberg Diakonale Hospital

Status: Enrolling

Conditions: Osteoarthritis; Primary; Degenerative Joint Disease of Knee

Treatments: Behavioral: Osteoarthritis education, exercise and CBT; Procedure: Total Knee Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03771430

MultiKnee Trial

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of cognitive behavioral therapy delivered as an e-therapy program, combined with physical exercise delivered by physiotherapists, for patients on waiting list for total knee arthroplasty. The patients will be randomized to either 1) a non-surgical program consisting of web-based cognitive behavioral therapy combined with physiotherapy, 2) total knee arthroplasty (TKA) surgery followed by web-based cognitive behavioral therapy combined with physiotherapy, or 3) a control group who undergo TKA followed by standard physiotherapy.

Full description

The study is a multidisciplinary trial testing an intervention delivered by physiotherapists. Up to 20% of total knee arthroplasty (TKA) patients continue to experience moderate/severe pain 12 months after TKA. While physical therapy (PT) and cognitive-behavior therapy (CBT) have shown promise for improving outcomes, they have not been evaluated in combination or in patients at risk for chronic pain after TKA. This trial will evaluate PT+CBT combined, either as a substitute for or as a supplement to TKA for patients at risk for chronic pain after TKA.

Pilot/Feasibility study:

The study will include a feasibility/pilot study with 15 patients to be performed from November 2018. The intervention and study procedures may be modified based on results from the feasibility/pilot study.

Full scale Randomized Controlled Trial (RCT):

The full-scale RCT will include 282 patients scheduled for TKA. Patients will be randomly assigned to one of three groups: 1) non-surgical intervention (i.e., PT+CBT), 2) a combination of TKA with pre- and postoperative PT+CBT, or 3) A control group receiving TKA and usual care follow-up. Primary outcome: The Pain subscale from the KOOS. The intervention has the potential to improve outcomes for patients who currently obtain little benefit from standard TKA.

Cross-sectional observational study: Patients declining to participate in the RCT will be offered the option to participate in a separate cross-sectional study. The inclusion and exclusion criteria will be identical to the RCT. Patients who agree to participate in the cross-sectional study will complete the same baseline questionnaires as in the RCT and are asked about the reasons they did not want to participate in the RCT.

Enrollment: 282 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 3 patient groups

Non-surgical group

Experimental group

Description:

Osteoarthritis education, exercise and eCBT

Treatment:

Behavioral: Osteoarthritis education, exercise and CBT

Combined group

Experimental group

Description:

Total knee arthroplasty + osteoarthritis education, exercise and eCBT

Treatment:

Behavioral: Osteoarthritis education, exercise and CBT

Procedure: Total Knee Arthroplasty

Surgery only (standard care)

Active Comparator group

Description:

Total knee arthroplasty + standard physiotherapy

Treatment:

Procedure: Total Knee Arthroplasty