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A Multidisciplinary Intervention in Total Knee Arthroplasty (MultiKnee)

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ClinicalTrials.gov Identifier: NCT03771430
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : June 29, 2021
Sponsor:
Collaborators:
Haukeland University Hospital
Martina Hansen's Hospital
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis; Primary Degenerative Joint Disease of Knee Behavioral: Osteoarthritis education, exercise and CBT Procedure: Total Knee Arthroplasty Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-surgical group
Osteoarthritis education, exercise and eCBT
Behavioral: Osteoarthritis education, exercise and CBT

Osteoarthritis Education

  1. 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

  2. 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
Other Name: AktivA

Experimental: Combined group
Total knee arthroplasty + osteoarthritis education, exercise and eCBT
Behavioral: Osteoarthritis education, exercise and CBT

Osteoarthritis Education

  1. 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

  2. 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
Other Name: AktivA

Procedure: Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Other Name: knee replacement

Active Comparator: Surgery only (standard care)
Total knee arthroplasty + standard physiotherapy
Procedure: Total Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Other Name: knee replacement




Primary Outcome Measures :
  1. 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. ]

    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.



Secondary Outcome Measures :
  1. 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 ]

    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.


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

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

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

    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.


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

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

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

    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).


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

    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".


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

    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


Other Outcome Measures:
  1. Pittsburgh Sleep Quality Index [ Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start ]
    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.

  2. The Hospital Anxiety and Depression Scale [ Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start ]
    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.

  3. The Fear-Avoidance Belief Questionnaire [ Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start ]
    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.

  4. Health Locus of Control Scale [ Time Frame: Before randomization. 3, 12 and 24 months following treatment start ]
    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.

  5. Self-reported level of physical activity [ Time Frame: Before randomization. 3, 6, 12 and 24 months following treatment start ]
    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.

  6. The ActiGraph Professional single-axis accelerometer [ Time Frame: Before treatment start. 6, 12 and 24 months following treatment start ]
    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

  7. The 40 meters walk test [ Time Frame: Before treatment start. 3, 6, 12 and 24 months following treatment start ]
    The 40 meter walk test: The patient is instructed to walk 40 meter under timing.

  8. Stair Climb Test [ Time Frame: Before treatment start. 3, 6, 12 and 24 months following treatment start ]
    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.

  9. Registry-based data on use of health care resources [ Time Frame: From before randomization until 3, 6, 12 and 24 months after treatment start. ]
    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.

  10. Radiographs: weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA) [ Time Frame: Before treatment start, 12 months following treatment start. ]
    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.

  11. Screening and recruitment of patients (pilot study with 15 patients). [ Time Frame: Baseline T1 before randomization ]
    Number of patients undergoing screening, considered for inclusion, eligible for inclusion, consenting to participate and undergoing randomization

  12. Adherence to the intervention (pilot study with 15 patients) [ Time Frame: From treatment start until 12 weeks following treatment start. ]
    Number of patients receiving the full dose of the intervention. adverse events, recruitment, screening and randomization, retention in study/loss to follow-up.

  13. Acceptability of the intervention (pilot study with 15 patients) [ Time Frame: From treatment start until 12 weeks following treatment start. ]
    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.

  14. Level of electronic health literacy [ Time Frame: Before treatment start, 6 months after treatment start ]
    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.

  15. Level of health literacy [ Time Frame: Before treatment start, 6 months after treatment start ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771430


Contacts
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Contact: Maren Falch Lindberg, PhD +4794815762 mfli@lds.no
Contact: Anners Lerdal, PhD +4795033144 anners.lerdal@medisin.uio.no

Locations
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Norway
Haukeland University Hospital - Kysthospitalet Hagevik Recruiting
Bergen, Norway
Contact: Kari Indrekvam, PhD    +47913 32 899    kari.indrekvam@helse-bergen.no   
Contact: Mona Badawy, PhD    +4756565927    mona.badawy@helse-bergen.no   
Sub-Investigator: Turid Rognsvåg, Msc         
Principal Investigator: Mona Badawy, PhD         
Lovisenberg Diaconal Hospital Recruiting
Oslo, Norway
Contact: Maren F Lindberg, PhD    +4794815762    m.k.f.lindberg@medisin.uio.no   
Contact: Anners Lerdal, PhD    22358206    anners.lerdal@medisin.uio.no   
Principal Investigator: Anners Lerdal, PhD         
Principal Investigator: Arild Aamodt, PhD         
Martina Hansens Hospital Recruiting
Oslo, Norway
Contact: Stig Heir, PhD         
Principal Investigator: Nina J Kise, PhD         
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Haukeland University Hospital
Martina Hansen's Hospital
Investigators
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Principal Investigator: Anners Lerdal, PhD Lovisenberg Diaconal Hospital, University of Oslo
Principal Investigator: Arild Aamodt, PhD Lovisenberg Diakonale Hospital
Study Director: Maren F Lindberg, PhD Lovisenberg Diakonale Hospital/University of Oslo
Study Chair: Kari Indrekvam, PhD Haukeland University Hospital - Kysthospitalet Hagevik/University of Bergen
Study Chair: Stig Heir, PhD Martina Hansens Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT03771430    
Other Study ID Numbers: MultiKnee Trial
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lovisenberg Diakonale Hospital:
Total knee arthroplasty
Physiotherapy
Cognitive behavioral therapy
e-therapy
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Osteoarthritis, Knee
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases