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| Name | Class |
|---|---|
| The Danish Rheumatism Association | OTHER |
| Obel Family Foundation | UNKNOWN |
| Spar Nord Foundation | UNKNOWN |
| The Bevica Foundation |
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The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).
The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study.
Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.
It is recommended both nationally and internationally that the treatment of knee OA should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement. If this non-surgical treatment is ineffective surgical treatment, especially surgery with insertion of total knee replacement (TKR), may be indicated. There are effects of both non-surgical treatment and TKR, but no studies exist, which examine the effect of surgery with insertion of TKR in addition to the recommended non-surgical treatment of knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDIC | Active Comparator | Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months. |
|
| MEDIC + TKR | Active Comparator | Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months after a total knee replacement. |
|
| Observational Cohort | Active Comparator | If the patient can be included, but doesn't want to participate in the randomization, the patient is offered to enter into a prospective observational cohort with the same endpoints and the same follow-up as in the randomized study. The participant can then, in consultation with his/her physician, choose whether they would like MEDIC-treatment or TKR in combination with MEDIC-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular training (NEMEX-TJR) | Other | 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score) | The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority. | Primary: 12months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EQ-5D From Baseline | Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description ("Links") Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best). | Primary: 12months. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcomes |
Further exploratory objectives may be added later on. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren T Skou, PhD-student | Orthopaedic Research Unit, Aalborg University Hospital, Denmark | Principal Investigator |
| Ewa M Roos, PhD | Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark | Study Chair |
| Lars Arendt-Nielsen, Dr.Sci.Med. | Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University | Study Chair |
| Mogens B Laursen, PhD | Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark | Study Chair |
| Sten Rasmussen, MD | Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark | Study Chair |
| Michael S Rathleff, PhD-student | Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark | Study Chair |
| Ole H Simonsen, Dr.Med. | Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Occupational and Physiotherapy, Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11156538 | Background | Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91. | |
| 18279766 | Background | Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013. |
| Label | URL |
|---|---|
| Link to the published statistical analysis plan | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | MEDIC | 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| UNKNOWN |
| Aalborg University | OTHER |
| Association of Danish Physiotherapists | OTHER |
| Formthotics | UNKNOWN |
| Medical Specialist Heinrich Kopp's Grant | UNKNOWN |
| Danish Medical Association | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Paracetamol | Drug | 1 g x 4/day |
|
|
| Burana | Drug | 400 mg x 3/day for three weeks |
|
|
| Pantoprazol | Drug | 20mg x 1/day for three weeks |
|
|
| Dietary counseling | Behavioral | For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs. |
|
|
| Patient education | Behavioral | The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden. |
|
|
| TKR | Procedure | Surgical treatment with insertion of total knee replacement following standard procedures. |
|
|
| Insoles | Other | The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). The participants will be advised to use the insoles in all shoes. |
|
|
| Change in Timed Up & Go (TUG) From Baseline | Primary: 12months. |
| Change in 20-meter Walk From Baseline | Primary: 12months. |
| Change in the Five Subscales of KOOS From Baseline | All subscales going from 0 to 100 (worst to best) | Primary: 12months. |
| Weight Change in kg From Baseline | Weight change in kg measured without shoes at the same time of day and on the same scale | Primary: 12months. |
| Proportion of Users of Pain Medication | With possible answers being yes and no | Baseline and 12months. |
| Serious Adverse Events Related to the Index Knee | Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants | Primary: 12months |
| Baseline, 3months, 6months, 12months and 24 months. |
| Farsoe Hospital |
| Farsø |
| 9640 |
| Denmark |
| Vendsyssel Hospital, Frederikshavn | Frederikshavn | 9900 | Denmark |
| 14644851 | Background | Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742. |
| Background | National Board of Health, Denmark. Referenceprogram for knæartrose. Copenhagen: National Board of Health, Denmark; 2007. [22.02.2010] found at: http://www.sst.dk/publ/Publ2007/PLAN/SfR/Refprg_knaeartrose.pdf |
| 17719803 | Background | Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27. |
| 11030685 | Background | Walker-Bone K, Javaid K, Arden N, Cooper C. Regular review: medical management of osteoarthritis. BMJ. 2000 Oct 14;321(7266):936-40. doi: 10.1136/bmj.321.7266.936. No abstract available. |
| 16543327 | Background | Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. doi: 10.1136/bmj.332.7542.639. No abstract available. |
| 26488691 | Background | Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467. |
| 31948990 | Derived | Skou ST, Roos E, Laursen M, Arendt-Nielsen L, Rasmussen S, Simonsen O, Ibsen R, Larsen AT, Kjellberg J. Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark. BMJ Open. 2020 Jan 15;10(1):e033495. doi: 10.1136/bmjopen-2019-033495. |
| 29723634 | Derived | Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S, Simonsen O. Total knee replacement and non-surgical treatment of knee osteoarthritis: 2-year outcome from two parallel randomized controlled trials. Osteoarthritis Cartilage. 2018 Sep;26(9):1170-1180. doi: 10.1016/j.joca.2018.04.014. Epub 2018 May 1. |
| 29369450 | Derived | Arendt-Nielsen L, Simonsen O, Laursen MB, Roos EM, Rathleff MS, Rasmussen S, Skou ST. Pain and sensitization after total knee replacement or nonsurgical treatment in patients with knee osteoarthritis: Identifying potential predictors of outcome at 12 months. Eur J Pain. 2018 Jul;22(6):1088-1102. doi: 10.1002/ejp.1193. Epub 2018 Feb 15. |
| 27029553 | Derived | Skou ST, Roos EM, Simonsen O, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S. The effects of total knee replacement and non-surgical treatment on pain sensitization and clinical pain. Eur J Pain. 2016 Nov;20(10):1612-1621. doi: 10.1002/ejp.878. Epub 2016 Mar 31. |
| 26304646 | Derived | Skou ST, Rasmussen S, Simonsen O, Roos EM. Knee Confidence as It Relates to Self-reported and Objective Correlates of Knee Osteoarthritis: A Cross-sectional Study of 220 Patients. J Orthop Sports Phys Ther. 2015 Oct;45(10):765-71. doi: 10.2519/jospt.2015.5864. Epub 2015 Aug 24. |
| 22571284 | Derived | Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen OH, Rasmussen S. Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study). BMC Musculoskelet Disord. 2012 May 9;13:67. doi: 10.1186/1471-2474-13-67. |
| FG001 | MEDIC + TKR | TKR: Surgical treatment with insertion of total knee replacement following standard procedures. Followed by: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MEDIC | 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). |
| BG001 | MEDIC + TKR | TKR: Surgical treatment with insertion of total knee replacement following standard procedures. Followed by: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score) | The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority. | Posted | Mean | 95% Confidence Interval | units on a scale | Primary: 12months. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in EQ-5D From Baseline | Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description ("Links") Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best). | Posted | Mean | 95% Confidence Interval | units on a scale | Primary: 12months. |
| |||||||||||||||||||||||||||||||
| Secondary | Change in Timed Up & Go (TUG) From Baseline | Posted | Mean | 95% Confidence Interval | sec | Primary: 12months. |
| ||||||||||||||||||||||||||||||||
| Secondary | Change in 20-meter Walk From Baseline | Posted | Mean | 95% Confidence Interval | sec | Primary: 12months. |
| ||||||||||||||||||||||||||||||||
| Secondary | Change in the Five Subscales of KOOS From Baseline | All subscales going from 0 to 100 (worst to best) | Posted | Mean | 95% Confidence Interval | units on a scale | Primary: 12months. |
| |||||||||||||||||||||||||||||||
| Secondary | Weight Change in kg From Baseline | Weight change in kg measured without shoes at the same time of day and on the same scale | Only patients with a BMI equal to or >25 were included in the analysis | Posted | Mean | 95% Confidence Interval | kg | Primary: 12months. |
| ||||||||||||||||||||||||||||||
| Secondary | Proportion of Users of Pain Medication | With possible answers being yes and no | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline and 12months. |
| |||||||||||||||||||||||||||||||
| Secondary | Serious Adverse Events Related to the Index Knee | Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants | Posted | Number | Serious adverse events related to knee | Primary: 12months |
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Exploratory Outcomes |
Further exploratory objectives may be added later on. | Will be reported in later publications, as it is exploratory outcomes | Posted | Baseline, 3months, 6months, 12months and 24 months. |
|
Not provided
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MEDIC | 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). | 5 | 50 | 38 | 50 | ||
| EG001 | MEDIC + TKR | TKR: Surgical treatment with insertion of total knee replacement following standard procedures. Followed by: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). | 20 | 50 | 45 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain in the opposite knee leading to TKR | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Carcinoid tumor in the small intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| cerebral thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Stiffness requiring brisement forcé | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Deep infection in knee joint | Infections and infestations | Systematic Assessment |
| ||
| Deep venous thrombosis requiring anticoagulation | Vascular disorders | Systematic Assessment |
| ||
| femoral neck fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| back pain leading to spinal fusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| abdominal pain with outpouching of the colon | Gastrointestinal disorders | Systematic Assessment |
| ||
| hiatal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| coronary thrombosis | Vascular disorders | Systematic Assessment |
| ||
| hospitalization due to suspicion of cerebral thrombosis caused by neurological symptoms in the legs | Vascular disorders | Systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| hospitalization due to depression and anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| atrial fibrillation | Vascular disorders | Systematic Assessment |
| ||
| leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| hospitalization due to retinal detachment | Eye disorders | Systematic Assessment |
| ||
| trauma to the cranium from a fall leading to hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| myelomatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Swelling in index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Instability of index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Decreased range of motion of index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint distortion of index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| sensation of the index knee locking up | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Calor and rubor around index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| soft tissue calcification at index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| hospital care due to liquid oozing from the TKR scar | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| superficial infection of TKR knee | Infections and infestations | Systematic Assessment |
| ||
| bleeding from the TKR wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| numbness around the TKR scar | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| increased soreness around the TKR knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pruritus around the knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| serious illness in the family | Social circumstances | Systematic Assessment |
| ||
| lack of motivation/time | Social circumstances | Systematic Assessment |
| ||
| eye surgery | Eye disorders | Systematic Assessment |
| ||
| impaired balance | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| medication intake resulting in fatigue | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| advised by doctor to reduce the intensity of exercise due to hypertension | Social circumstances | Systematic Assessment |
| ||
| advised by doctor to exercise only once a week due to a lack of leukocytes | Social circumstances | Systematic Assessment |
| ||
| neuropathic wound on the foot | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| abscess in the gluteal region | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pain in the opposite knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pain in the opposite knee with previous TKR | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pain in the hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| hand/finger surgery/fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| painful pes planus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| sciatic nerve pain | Nervous system disorders | Systematic Assessment |
| ||
| low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| rib, head and hip pain following two falls | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| short-lasting restless legs | Nervous system disorders | Systematic Assessment |
| ||
| paresthesia of the foot | Nervous system disorders | Systematic Assessment |
| ||
| shoulder surgery due to rupture of m. supraspinatus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| lateral ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| ankle sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| pain in the hamstrings muscles | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ankylosing Spondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| shoulder injury from a fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| muscle strain in the upper thigh | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| plantar fasciitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| low haemoglobin percentage | Blood and lymphatic system disorders | Systematic Assessment |
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| abnormal swelling of the whole leg in the days after TKR surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| nausea | General disorders | Systematic Assessment |
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| nerve pain | Nervous system disorders | Systematic Assessment |
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| tranexamic acid given pre-surgery by mistake (unintended event) | Injury, poisoning and procedural complications | Systematic Assessment |
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| puncture of the synovial membrane during lateral release | Injury, poisoning and procedural complications | Systematic Assessment |
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| mental unstability | Psychiatric disorders | Systematic Assessment |
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| loss of consciousness leading to a fall | Vascular disorders | Systematic Assessment |
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| lack of skin under the foot resulting in pain and limping | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| increased need of insulin | Metabolism and nutrition disorders | Systematic Assessment |
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| Achilles tendinopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| iliotibial band syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| swelling of the foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| muscle cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| quadriceps strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| back and hip pain following a fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| pain in the hamstrings muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| short-lasting vertigo | Vascular disorders | Systematic Assessment |
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| reduced walking distance | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Søren T. Skou | Aalborg University Hospital | +4523708640 | sots@rn.dk |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077402 | Pantoprazole |
| D015596 | Nutrition Assessment |
| D010353 | Patient Education as Topic |
| D019645 | Arthroplasty, Replacement, Knee |
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
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TKR: Surgical treatment with insertion of total knee replacement following standard procedures. Followed by: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). |
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| OG001 | MEDIC + TKR | TKR: Surgical treatment with insertion of total knee replacement following standard procedures. Followed by: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. Paracetamol: 1 g x 4/day Burana: 400 mg x 3/day Pantoprazol: 20mg x 1/day Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet. Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). |
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