A Multidisciplinary Intervention in Total Knee Arthroplasty

Degenerative Joint Disease of Knee Clinical Trial

— MultiKnee  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03771430
• Other study ID #: MultiKnee Trial
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: Lovisenberg Diakonale Hospital
• Contact: Maren Falch Lindberg, PhD
• Phone: +4794815762
• Email: mfli[@]lds.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Joint Disease of Knee
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Osteoarthritis education, exercise and CBT
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

Procedure:
• Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital - Kysthospitalet Hagevik	Bergen
Norway	Lovisenberg Diaconal Hospital	Oslo
Norway	Martina Hansens Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	Haukeland University Hospital, Martina Hansen's Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality index (PSQI) is a widely-used self-report measure of sleep disturbance during the past month. The PSQI consists of 19 items that measures different aspects of sleep. The 19 items produce 7 component scores (i.e., duration of sleep, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, overall sleep quality, need for sleep medications) each ranging from 0-3 where higher score indicate poorer sleep. All component scores can be summarized to a global score that range from 0 to 21 where higher scores indicate poorer sleep quality. The PSQI has good validity and reliability.	Before randomization. 3, 6, 12 and 24 months following treatment start
Other	The Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (HADS) will be used to measure self-reported psychological distress (depression and anxiety). The scale consists of 14 items, 7 on the depression subscale and 7 on the anxiety subscale. The Norwegian version has excellent psychometric properties. Each subscale range from 0-21 where higher scores indicate higher levels of anxiety or depression. A total score (range 0 - 42) can be calculated from summarizing all the 14 items. Higher scores indicate higher levels of anxiety/depression.	Before randomization. 3, 6, 12 and 24 months following treatment start
Other	The Fear-Avoidance Belief Questionnaire	The Fear-Avoidance Belief Questionnaire (FABQ) will be used to measure pain-related fear of movement. The instrument consists of 2 subscales, fear-avoidance beliefs for work, and fear-avoidance beliefs for physical activity (FABQ-PA). Only the FABQ-PA subscale will be used in this study. The FABQ-PA consists of 4 items where patients rate their agreement with 5 statements about pain and physical activity. The FABQ-PA range from 0-24 and higher scores indicate higher levels of pain-related fear of movement.	Before randomization. 3, 6, 12 and 24 months following treatment start
Other	Health Locus of Control Scale	The Health Locus of Control Scale (HLCS) will be used to measure patients' anticipations between own health and disease behavior and consequences of the behavior. The scale consists of 18 statements. Patients rate their agreement on a 6 point likert scale ranging from disagrees completely to agrees completely. Scoring: The scoring system consists of 3 subscales: The Internal Locus of Control, the Powerful Others Health Locus of Control, and the Chance Health Locus of control. The scores are obtained by summing items for each subscale. Higher scores indicate stronger agreement or inclination towards that particular subscale.	Before randomization. 3, 12 and 24 months following treatment start
Other	Self-reported level of physical activity	Self-reported level of physical activity will be measured using two items from the Norwegian Hunt2 survey that assess frequency of light and hard physical activity, and the Stages of Change for physical activity. The Stages of Change for physical activity assess patients' readiness for physical activity. Patients rate their agreement with five different statements about physical activity.	Before randomization. 3, 6, 12 and 24 months following treatment start
Other	The ActiGraph Professional single-axis accelerometer	The ActiGraph Professional single-axis accelerometer, a body worn sensor system to measure physical activity, will be used to measure time in sedentary and active positions, duration of activity and number of steps during walking	Before treatment start. 6, 12 and 24 months following treatment start
Other	The 40 meters walk test	The 40 meter walk test: The patient is instructed to walk 40 meter under timing.	Before treatment start. 3, 6, 12 and 24 months following treatment start
Other	Stair Climb Test	The Stair Climb Test will be used to measure ascending and descending stair activity, and lower body strength and balance, measured as a participants' time in seconds to ascend and descend a flight of stairs.	Before treatment start. 3, 6, 12 and 24 months following treatment start
Other	Registry-based data on use of health care resources	Use of health care resources will be measured using registry data from the KUHR-system (i.e., control and payment of reimbursements to health service providers), the Norwegian Patient Registry (NPR) FD Trygd social security database, the Norwegian Prescription Database and the Norwegian Arthroplasty registry. All information will be anonymized and linked to each patient using a code number before analysis.	From before randomization until 3, 6, 12 and 24 months after treatment start.
Other	Radiographs: weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA)	X-rays including weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA) weightbearing AP view (HKA). OA severity grading will be performed according to the Kellgren-Lawrence grading system and cartilage thickness.	Before treatment start, 12 months following treatment start.
Other	Screening and recruitment of patients (pilot study with 15 patients).	Number of patients undergoing screening, considered for inclusion, eligible for inclusion, consenting to participate and undergoing randomization	Baseline T1 before randomization
Other	Adherence to the intervention (pilot study with 15 patients)	Number of patients receiving the full dose of the intervention. adverse events, recruitment, screening and randomization, retention in study/loss to follow-up.	From treatment start until 12 weeks following treatment start.
Other	Acceptability of the intervention (pilot study with 15 patients)	Number of patients feeling overwhelmed or burdened by the intervention. Number of patients not completing the intervention due to feeling overwhelmed ro burdened by the intervention.	From treatment start until 12 weeks following treatment start.
Other	Level of electronic health literacy	The Electronic Health Literacy Questionnaire (e-HLQ) (44) will be used to measure patients level of electronic health literacy prior to, and six months following surgery. In this study, 4 domains will be assessed: 1) using technology to process health information, 2) understanding of health concepts and language, 3) ability to actively engage with digital services, 4) motivated to engage with digital services. The scores range 1-4, with high scores indicating high e-health literacy.	Before treatment start, 6 months after treatment start
Other	Level of health literacy	The International Health Literacy Population survey Questionnaire 2019-2021(HLS19-Q47) will be used to measure patients' level of health literacy prior to, and six months following surgery. The original HLS-19-Q47 consist of 47 items. In this study, 2 domains will be assessed: 1) Health promotion and 2) General health literacy.	Before treatment start, 6 months after treatment start
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.