Osteoarthritis; PrimaryMultiKneeNCT03771430
A Multidisciplinary Intervention in Total Knee Arthroplasty
A study testing Osteoarthritis education, exercise and CBT and Total Knee Arthroplasty in people with Osteoarthritis; Primary and Degenerative Joint Disease of Knee, run by Lovisenberg Diakonale Hospital at 3 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Osteoarthritis; Primary, Degenerative Joint Disease of Knee
- What is being tested?
- Osteoarthritis education, exercise and CBT and Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 3 sitesNorway
- Study dates
- 28 Aug 2019to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Norway3 sites
Haukeland University Hospital - Kysthospitalet Hagevik
Bergen
Martina Hansens Hospital
Oslo, Norway
Lovisenberg Diaconal Hospital
Oslo
About this study
Official title: A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)
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.
Read the 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.
- Being tested
- Osteoarthritis education, exercise and CBT, Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Physiotherapy, Cognitive behavioral therapy, e-therapy
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoarthritis education, exercise and CBTBehavioural
Also called AktivA
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
Total Knee ArthroplastyProcedure or surgery
Also called knee replacement
Standard total knee arthroplasty will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical group | Experimental | Osteoarthritis education, exercise and eCBT Receives: Behavioral: Osteoarthritis education, exercise and CBT |
| Combined group | Experimental | Total knee arthroplasty + osteoarthritis education, exercise and eCBT Receives: Behavioral: Osteoarthritis education, exercise and CBT; Procedure: Total Knee Arthroplasty |
| Surgery only (standard care) | Active comparator | Total knee arthroplasty + standard physiotherapy Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured before randomization, 3, 6, 12 and 24 months after treatment start.12 months after treatment start will be the primary endpoint.
Secondary outcomes (6)
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.
Measured: Before randomization. 3, 6, 12 and 24 months following treatment start.12 months after treatment start will be the secondary endpoint.
General health state
Patients' perceived health state will be measured on a visual analog scale that range from 0 - 100, higher levels indicate better health state, using the widely used EuroQol-5 (EQ-5D-5L). Only the health-state item will be a secondary outcome. The remaining parts of the EQ-5D-5L will be included in the economic evaluation of the intervention.
Measured: Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
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.
Measured: Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
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).
Measured: At 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
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.
Measured: Before treatment start. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
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
Measured: From treatment start until 12 months following treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start28 Aug 2019
- Primary completion30 Apr 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis; PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Maren F Lindberg, PhD, Principal investigator, Lovisenberg Diakonale Hospital/University of OsloAnners Lerdal, PhD, Study chair, Lovisenberg Diaconal Hospital, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771430
- Sponsor's protocol ID
- MultiKnee Trial
- Acronym
- MultiKnee
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kise NJ, Eliassen S, Furnes O, Gay C, Heir S, Lerdal A, Lindberg MF, Rognsvag T, Aamodt A, Nerhus TK. Fear avoidance and catastrophizing are associated with both knee awareness and quality of life in knee osteoarthritis patients: a secondary report of a cross-sectional study. Acta Orthop. 2025 Dec 18;96:920-926. doi: 10.2340/17453674.2025.45070.
PubMed 41410384Rognsvag T, Bergvad IB, Furnes O, Indrekvam K, Lerdal A, Lindberg MF, Skou ST, Stubberud J, Badawy M. Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study. Pilot Feasibility Stud. 2024 Feb 28;10(1):43. doi: 10.1186/s40814-024-01470-y.
PubMed 38419024Lindberg MF, Aamodt A, Badawy M, Bergvad IB, Borchgrevink P, Furnes O, Gay C, Heir S, Holm I, Indrekvam K, Kise N, Lau B, Magnussen J, Nerhus TK, Rognsvag T, Rudsengen DE, Rustoen T, Skou ST, Stubberud J, Smastuen MS, Lerdal A. The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial. BMC Musculoskelet Disord. 2021 Dec 20;22(1):1054. doi: 10.1186/s12891-021-04924-z.
PubMed 34930194Rognsvag T, Lindberg MF, Lerdal A, Stubberud J, Furnes O, Holm I, Indrekvam K, Lau B, Rudsengen D, Skou ST, Badawy M. Development of an internet-delivered cognitive behavioral therapy program for use in combination with exercise therapy and education by patients at increased risk of chronic pain following total knee arthroplasty. BMC Health Serv Res. 2021 Oct 25;21(1):1151. doi: 10.1186/s12913-021-07177-7.
PubMed 34696785
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)
- ClinicalTrials.gov ID
- NCT03771430
- Acronym / sponsor ID
- MultiKnee / MultiKnee Trial
- Keywords
- Total knee arthroplasty, Physiotherapy, Cognitive behavioral therapy, e-therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Vestre Viken Hospital Trust
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-surgical group | Experimental | Behavioral: Osteoarthritis education, exercise and CBTOsteoarthritis education, exercise and eCBT |
| Combined group | Experimental | Behavioral: Osteoarthritis education, exercise and CBT, Procedure: Total Knee ArthroplastyTotal knee arthroplasty + osteoarthritis education, exercise and eCBT |
| Surgery only (standard care) | Active comparator | Procedure: Total Knee ArthroplastyTotal knee arthroplasty + standard physiotherapy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteoarthritis education, exercise and CBTAlso: AktivAOsteoarthritis 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 | Behavioural | Combined group, Non-surgical group |
| Total Knee ArthroplastyAlso: knee replacementStandard total knee arthroplasty will be performed. | Procedure or surgery | Combined group, Surgery only (standard care) |
Primary outcome
Change in the knee injury and osteoarthritis score (KOOS) pain subscale
Time frame: Measured before randomization, 3, 6, 12 and 24 months after treatment start.12 months after treatment start will be the primary endpoint.
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.
6 secondary outcomes
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.12 months after treatment start will be the secondary endpoint.
General health state
Time frame: Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
Pain Catastrophizing Scale
Time frame: Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
Patient-acceptable symptom state, perceived treatment failure.
Time frame: At 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
The 30 second sit to stand test
Time frame: Before treatment start. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.
Adverse events/serious adverse events
Time frame: From treatment start until 12 months following treatment start.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 41410384Kise NJ, Eliassen S, Furnes O, Gay C, Heir S, Lerdal A, Lindberg MF, Rognsvag T, Aamodt A, Nerhus TK. Fear avoidance and catastrophizing are associated with both knee awareness and quality of life in knee osteoarthritis patients: a secondary report of a cross-sectional study. Acta Orthop. 2025 Dec 18;96:920-926. doi: 10.2340/17453674.2025.45070.
- Derived from this study: PubMed 38419024Rognsvag T, Bergvad IB, Furnes O, Indrekvam K, Lerdal A, Lindberg MF, Skou ST, Stubberud J, Badawy M. Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study. Pilot Feasibility Stud. 2024 Feb 28;10(1):43. doi: 10.1186/s40814-024-01470-y.
- Derived from this study: PubMed 34930194Lindberg MF, Aamodt A, Badawy M, Bergvad IB, Borchgrevink P, Furnes O, Gay C, Heir S, Holm I, Indrekvam K, Kise N, Lau B, Magnussen J, Nerhus TK, Rognsvag T, Rudsengen DE, Rustoen T, Skou ST, Stubberud J, Smastuen MS, Lerdal A. The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial. BMC Musculoskelet Disord. 2021 Dec 20;22(1):1054. doi: 10.1186/s12891-021-04924-z.
- Derived from this study: PubMed 34696785Rognsvag T, Lindberg MF, Lerdal A, Stubberud J, Furnes O, Holm I, Indrekvam K, Lau B, Rudsengen D, Skou ST, Badawy M. Development of an internet-delivered cognitive behavioral therapy program for use in combination with exercise therapy and education by patients at increased risk of chronic pain following total knee arthroplasty. BMC Health Serv Res. 2021 Oct 25;21(1):1151. doi: 10.1186/s12913-021-07177-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maren F Lindberg, PhD principal investigator
Lovisenberg Diakonale Hospital/University of Oslo
Anners Lerdal, PhD study chair
Lovisenberg Diaconal Hospital, University of Oslo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoarthritis education, exercise and CBT and Total Knee Arthroplasty in people with Osteoarthritis; Primary and Degenerative Joint Disease of Knee, run by Lovisenberg Diakonale Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the knee injury and osteoarthritis score (KOOS) pain subscale (time frame: Measured before randomization, 3, 6, 12 and 24 months after treatment start.12 months after treatment start will be the primary endpoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771430, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.