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| Name | Class |
|---|---|
| The Danish Rheumatism Association | OTHER |
| Association of Danish Physiotherapists | OTHER |
Not provided
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The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.
The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment 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 osteoarthritis 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.
However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.
The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDIC | Active Comparator | Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months. |
|
| Standard treatment | Active Comparator | Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. |
|
| 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 From Baseline in KOOS4 (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. 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 From Baseline in EQ-5D | 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 (available under "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 |
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Søren T. Skou, PhD-student | Orthopaedic Research Unit, Aalborg University Hospital, Denmark | Principal Investigator |
| Ewa M. Roos, PhD | Research Unit for Musculoskeletal Function and Physiotherapy, 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, M.D. | 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.Sci.Med. | Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital | Aalborg | 9000 | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 20170770 |
| Label | URL |
|---|---|
| Link to the published statistical analysis plan | View source |
Not provided
Not provided
Not provided
Not provided
| 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 Pantoprazole: 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). The participants will be advised to use the insoles in all shoes. |
| FG001 | Standard Treatment | Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information will be given in a leaflet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 Pantoprazole: 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). The participants will be advised to use the insoles in all shoes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 From Baseline in KOOS4 (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. 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. |
|
Not provided
Not provided
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 Pantoprazole: 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). The participants will be advised to use the insoles in all shoes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Søren T. Skou | Aalborg University Hospital | +4523708640 | sots@rn.dk |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077402 | Pantoprazole |
| D015596 | Nutrition Assessment |
| D010353 | Patient Education as Topic |
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Information | Behavioral | Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information will be given in a leaflet. |
|
|
| Paracetamol | Drug | 1 g x 4/day |
|
|
| Burana | Drug | 400 mg x 3/day for three weeks |
|
|
| Pantoprazole | 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. |
|
|
| 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 From Baseline in 20-meter Walk | Primary: 12months. |
| Change in the Five KOOS Subscale Scores From Baseline | Range of all subscales are 0 to 100 (worst to best). | Primary: 12 months. |
| 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. |
| Number of Serious Adverse Events Reported at 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. |
| Change From Baseline in Time From the Timed Up and Go | Primary: 12 months. |
| Baseline, 3months, 6months, 12months and 24months |
| Farsoe Hospital |
| Farsø |
| 9640 |
| Denmark |
| Vendsyssel Hospital, Frederikshavn | Frederikshavn | 9900 | Denmark |
| Background |
| Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, 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 III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11. |
| 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. |
| 12483739 | Background | Fortin PR, Penrod JR, Clarke AE, St-Pierre Y, Joseph L, Belisle P, Liang MH, Ferland D, Phillips CB, Mahomed N, Tanzer M, Sledge C, Fossel AH, Katz JN. Timing of total joint replacement affects clinical outcomes among patients with osteoarthritis of the hip or knee. Arthritis Rheum. 2002 Dec;46(12):3327-30. doi: 10.1002/art.10631. |
| 19968215 | Background | Rossi MD, Eberle T, Roche M, Waggoner M, Blake R, Burwell B, Baxter A. Delaying knee replacement and implications on early postoperative outcomes: a pilot study. Orthopedics. 2009 Dec;32(12):885. doi: 10.3928/01477447-20091020-06. |
| 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 |
| 25937024 | Background | Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Roos EM. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage. 2015 Sep;23(9):1465-75. doi: 10.1016/j.joca.2015.04.021. Epub 2015 Apr 30. |
| 36428014 | Derived | Larsen JB, Roos EM, Laursen M, Holden S, Johansen MN, Rathleff MS, Arendt-Nielsen L, Rasmussen S, Skou ST. Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial. BMJ Open. 2022 Nov 25;12(11):e060169. doi: 10.1136/bmjopen-2021-060169. |
| 32243994 | Derived | Skou ST, Roos EM, Laursen M, Arendt-Nielsen L, Rasmussen S, Simonsen O, Ibsen R, Larsen AT, Kjellberg J. Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial. Osteoarthritis Cartilage. 2020 Jul;28(7):907-916. doi: 10.1016/j.joca.2020.03.009. Epub 2020 Mar 31. |
| 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. |
| 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. |
| 26241775 | Derived | Skou ST, Roos EM, Simonsen O, Laursen MB, Rathleff MS, Arendt-Nielsen L, Rasmussen S. The efficacy of non-surgical treatment on pain and sensitization in patients with knee osteoarthritis: a pre-defined ancillary analysis from a randomized controlled trial. Osteoarthritis Cartilage. 2016 Jan;24(1):108-16. doi: 10.1016/j.joca.2015.07.013. Epub 2015 Aug 1. |
| 23151395 | Derived | Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. Efficacy of multimodal, systematic non-surgical treatment of knee osteoarthritis for patients not eligible for a total knee replacement: a study protocol of a randomised controlled trial. BMJ Open. 2012 Nov 14;2(6):e002168. doi: 10.1136/bmjopen-2012-002168. Print 2012. |
| BG001 | Standard Treatment | Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information will be given in a leaflet. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
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
Pantoprazole: 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).
The participants will be advised to use the insoles in all shoes.
| OG001 | Standard Treatment | Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information will be given in a leaflet. |
|
|
| Secondary | Change From Baseline in EQ-5D | 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 (available under "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 From Baseline in 20-meter Walk | Posted | Mean | 95% Confidence Interval | sec | Primary: 12months. |
|
|
|
| Secondary | Change in the Five KOOS Subscale Scores From Baseline | Range of all subscales are 0 to 100 (worst to best). | Posted | Number | 95% Confidence Interval | units on a scale | Primary: 12 months. |
|
|
|
| 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 this 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 | Number of Serious Adverse Events Reported at 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. |
|
|
|
| Secondary | Change From Baseline in Time From the Timed Up and Go | Posted | Mean | 95% Confidence Interval | sec | Primary: 12 months. |
|
|
|
| Other Pre-specified | Exploratory Outcomes |
| Since this is exploratory outcomes they will be analyzed in future publications. | Posted | Baseline, 3months, 6months, 12months and 24months |
|
|
| 11 |
| 50 |
| 17 |
| 50 |
| EG001 | Standard Treatment | Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. Information will be given in a leaflet. | 14 | 50 | 14 | 50 |
| Arthrodesis of contralateral foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Erysipelas | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Intestinal cancer | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Knee arthroscopy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood transfusion during TKR surgery | Blood and lymphatic system disorders | Systematic Assessment |
|
| pain without loosening of the prosthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture of os sacrum | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Low back pain radiating to leg | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Frature of collum femoris | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| heart problems | Vascular disorders | Systematic Assessment |
|
| severe physical decline due to influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| renal-artery stenosis | Vascular disorders | Systematic Assessment |
|
| Atherosclerosis demanding angioplasty | Vascular disorders | Systematic Assessment |
|
| canalolithiasis | Ear and labyrinth disorders | Systematic Assessment |
|
| Instability after TKR | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling after TKR | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling in index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Decreased range of motion in index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Calor around index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rubor | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Achilles Tendinopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Broken toe | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| foot painof short duration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| intermittent hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| sciatic nerve pain of short duration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ankle sprain (grade I) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pain in the contralateral knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hamstring strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| 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 |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| Activities of Daily Living |
|
| Sports and recreation |
|
| Quality of Life |
|