A Multidisciplinary Intervention in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)

Conditions
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Osteoarthritis; Primary, Degenerative Joint Disease of Knee

Intervention / Treatment
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* Behavioral: Osteoarthritis education, exercise and CBT
* Procedure: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for TKA for OA at Lovisenberg, Oslo; Martina Hansen, Bærum, or Coastal Hospital Hagevik, Bergen Age 18 - 79 years ASA grade 1-3 KL grade 3 or 4 BMI<40 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-surgical group<br>Osteoarthritis education, exercise and eCBT | Behavioral: Osteoarthritis education, exercise and CBT<br>* Osteoarthritis Education 60-min session by AktivA trained PT) Signs/symptoms, risk factors, weight control, treatment Importance of physical activity Appropriate activity & training modalities Exercise and CBT Support 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT) Warm-up session Strengthening exercises Functional exercises Stretching Monitoring of CBT progress Review of CBT lessons learned Integration of CBT skills Enhance motivation to continue Online CBT (iCBT) (10 modules completed at home) Pain causes & prevention Pain management Health promotion & stress reduction at home & work Adapting for leisure & work Controlling flare-ups Maintaining & improving results<br>* Other names: AktivA;|
| Experimental: Combined group<br>Total knee arthroplasty + osteoarthritis education, exercise and eCBT | Behavioral: Osteoarthritis education, exercise and CBT<br>* Osteoarthritis Education 60-min session by AktivA trained PT) Signs/symptoms, risk factors, weight control, treatment Importance of physical activity Appropriate activity & training modalities Exercise and CBT Support 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT) Warm-up session Strengthening exercises Functional exercises Stretching Monitoring of CBT progress Review of CBT lessons learned Integration of CBT skills Enhance motivation to continue Online CBT (iCBT) (10 modules completed at home) Pain causes & prevention Pain management Health promotion & stress reduction at home & work Adapting for leisure & work Controlling flare-ups Maintaining & improving results<br>* Other names: AktivA;Procedure: Total Knee Arthroplasty<br>* Standard total knee arthroplasty will be performed.<br>* Other names: knee replacement;|
| Active Comparator: Surgery only (standard care)<br>Total knee arthroplasty + standard physiotherapy | Procedure: Total Knee Arthroplasty<br>* Standard total knee arthroplasty will be performed.<br>* Other names: knee replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the knee injury and osteoarthritis score (KOOS) pain subscale | KOOS is a knee-specific, patient administered questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire. The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. The pain subscale of the KOOS consists of 9 items that assess frequency of pain and pain severity in different situations. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. The pain subscale score will be transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. KOOS has 5 subscales: pain, other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related QOL. The KOOS has been validated for use in TKA and has been shown to be valid, reliable and responsive. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. Each of the subscale scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems. KOOS is a patient-administered questionnaire. | Before randomization. 3, 6, 12 and 24 months following treatment start | 
| The 30 second sit to stand test | The 30-second sit to stand test will be used to assess functional lower extremity strength. This test is performed using a chair of standard height without arms. The participant is encouraged to complete as many full stands as possible within 30 seconds. | Before treatment start. 3, 6, 12 and 24 months following treatment start | 
| Brief Pain inventory | The Brief Pain Inventory (BPI) will be used to measure pain (56). The BPI is a brief patient-completed questionnaire that consists of four items that measure pain intensity (on an 11-point numeric rating scale from 0-10), seven questions on pain interference with functioning, a body map to localize the pain and one item on pain relief. | Before randomization. 3, 6, 12 and 24 months following treatment start | 
| EuroQol-5D-5L | The widely used EuroQol-5 (EQ-5D-5L) will be used to measure health-related quality of life. The EQ5D-5L consists of two parts: A descriptive system (Mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-VAS that record patients self-rated health on a visual analog scale that range from 0 - 100, higher levels indicate better self-rated health. The descriptive system can be converted to a single summary index number where lower levels indicate poorer health-related quality of life. | Before randomization. 3, 6, 12 and 24 months following treatment start | 
| The Forgotten Joint Score | The Forgotten Joint Score will be used to assess how natural the prosthesis feels after total knee arthroplasty. The scoring system consists of 12 items that assess patients agreement with 12 statements, that range from 1 (never) to 5 (mostly). The raw score is transformed to a 0-100 score and then reversed to obtain the final score. A higher score indicate better outcome. | Before randomization. 3, 6, 12 and 24 months following treatment start | 
| Pain Catastrophizing Scale | The Pain Catastrophizing scale (PCS) will be used to measure catastrophic thinking related to pain. The scale consist of 13 items that range from 0 -4. The PCS assesses three dimensions of catastrophizing (i.e., rumination (range 0-16), magnification (range: 0-12, helplessness (range 0 -24). Higher scores indicate higher levels of catastrophic thinking related to pain. A total score can be computed by summing responses to all 13 items. PCS total scores range from 0-52. Higher scores indicate higher levels of catastrophic thinking related to pain. | Before randomization. 3, 6, 12 and 24 months following treatment start | 
| Patient-acceptable symptom state, perceived treatment failure. | Patient-acceptable symptom state will be measured by a single item question. The patient state wether they consider their knee function satisfactory or not (Yes/No). Perceived treatment failure will be measured by a single item question. The patient state whether their situation is so dissatisfying that they consider the treatment as a failure (Yes/No). | At 3, 6, 12 and 24 months following treatment start. | 
| Global perceived effect | The patient rate their level of knee problems compared to their condition before they started their treatment, by choosing on of seven statements that describe the level of improvement/worsening. The statements range from better - an important improvement - to worse, an important worsening. | At 3, 6, 12 and 24 months following treatment start. | 
| Adverse events/serious adverse events | All events reported by participant, physiotherapist or documented in the patient's hospital record. During surgery: Number of patients with fractures (Tibia, patella, femur), nerve or vascular injury, rupture of patella tendon, other. Postoperatively: Number of patients with deep infection, any secondary surgery (e.g., skin necrosis or scar tissue adherences, DAIR, MUA, secondary insertion of patella component, partial/total revision surgery), supracondylar femur fracture, patella fracture, permanent n. peroneus paresis, aseptic loosening, polyethylene defect (tibia or patella), instability requiring intervention, thrombophlebitis demanding anticoagulant treatment, pulmonary embolism, myocardial infarction, cerebral insult, other events. Patient-reported myocardial infarction, cerebral insult, pulmonary embolism or DVT within 3 months following intervention. All events reported by patients or physiotherapists - open probe questionnairing | From treatment start until 24 months following treatment start. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Physiotherapy, Cognitive behavioral therapy, e-therapy