Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-28 @ 11:44 AM
Study NCT ID:
NCT01469403
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2011-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss Intervention Before Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061217', 'term': 'Weight Reduction Programs'}], 'ancestors': [{'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SF-36', 'timeFrame': 'Measured 12 months postoperatively.', 'description': "A patient reported outcome (PRO). The questionnaire is a tool for measuring health status. The form is used to measure the patient's view of his own health by scoring standardized responses to standardized questions. The schedule consists of 36 questions representing eight health concepts."}], 'secondaryOutcomes': [{'measure': '6 minutes walk test (6MW).', 'timeFrame': 'Measured 1 week before surgery.', 'description': "Used to target the operating level of the patient's daily activities."}, {'measure': 'Body composition', 'timeFrame': 'Measured 1 week before surgery.', 'description': "Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage."}, {'measure': 'Bone mineral density (BMD).', 'timeFrame': 'Measured 12 months postoperatively.', 'description': 'Measured by DEXA scan.'}, {'measure': 'KOOS', 'timeFrame': 'Measured 1 week before surgery.', 'description': "Knee - specific patient-reported outcome that measures the patient's own assessment of knee problems and related problems. The schedule consists of 42 questions representing 5 strands."}, {'measure': 'Pain', 'timeFrame': 'Measured 1 week before surgery.', 'description': 'Visual Analogue Scale (VAS pain score)'}, {'measure': 'Serum leptin.', 'timeFrame': 'Measured 1 week before surgery.', 'description': 'Leptin is a hormone produced in fat tissue.'}, {'measure': 'Heart rate', 'timeFrame': 'Measured 1 week before surgery.', 'description': 'Cardiovascular complications.'}, {'measure': 'Blood pressure', 'timeFrame': 'Measured 1 week before surgery.', 'description': 'Cardiovascular complications.'}, {'measure': '6 minutes walk test (6MW).', 'timeFrame': 'Measured 8 week postoperatively.', 'description': "Used to target the operating level of the patient's daily activities."}, {'measure': '6 minutes walk test (6MW).', 'timeFrame': 'Measured 12 months postoperatively', 'description': "Used to target the operating level of the patient's daily activities."}, {'measure': 'Body composition', 'timeFrame': 'Measured 8 week postoperatively', 'description': "Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage."}, {'measure': 'Body composition', 'timeFrame': 'Measured 12 months postoperatively', 'description': "Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage."}, {'measure': 'KOOS', 'timeFrame': 'Measured 8 week postoperatively', 'description': "Knee - specific patient-reported outcome that measures the patient's own assessment of knee problems and related problems. The schedule consists of 42 questions representing 5 strands."}, {'measure': 'KOOS', 'timeFrame': 'Measured 12 months postoperatively', 'description': "Knee - specific patient-reported outcome that measures the patient's own assessment of knee problems and related problems. The schedule consists of 42 questions representing 5 strands."}, {'measure': 'Pain', 'timeFrame': 'Measured 8 week postoperatively', 'description': 'Visual Analogue Scale (VAS pain score)'}, {'measure': 'Pain', 'timeFrame': 'Measured 12 months postoperatively', 'description': 'Visual Analogue Scale (VAS pain score)'}, {'measure': 'Serum leptin.', 'timeFrame': 'Measured 8 week postoperatively', 'description': 'Leptin is a hormone produced in fat tissue.'}, {'measure': 'Serum leptin.', 'timeFrame': 'Measured 12 months postoperatively', 'description': 'Leptin is a hormone produced in fat tissue.'}, {'measure': 'Heart rate', 'timeFrame': 'Measured 8 week postoperatively', 'description': 'Cardiovascular complications.'}, {'measure': 'Heart rate', 'timeFrame': 'Measured 12 months postoperatively', 'description': 'Cardiovascular complications.'}, {'measure': 'Blood pressure', 'timeFrame': 'Measured 8 week postoperatively', 'description': 'Cardiovascular complications.'}, {'measure': 'Blood pressure', 'timeFrame': 'Measured 12 months postoperatively', 'description': 'Cardiovascular complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis, knee', 'Obesity', 'Weight Loss', 'Arthroplasty'], 'conditions': ['Osteoarthritis, Knee', 'Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the efficacy in a group of patients who must follow the current procedure for treatment of artificial knee, compared with a group of patients who must undergo an 8-week weight loss program before surgery. 1 year after surgery the investigators will examine whether there are differences between the two groups' quality of life and functional capacity.", 'detailedDescription': "Background In Denmark the numbers of primary total knee arthroplasty (TKA) operations annually increase. In the year 2000 was performed approximately 2,500 operations and in 2008 was performed more than 7,500 total knee arthroplasty operations, and there appears in all countries to be similar tendency. Meanwhile, the prevalence of overweight and obesity has increased markedly over the last 50 years. Approximately 13% of the Danish population is obese. For several years the association between obesity and knee osteoarthritis (OA) has been recognized, and osteoarthritis is the most frequent indication for total knee arthroplasty(80%).\n\nThe purpose of this study is to investigate whether weight loss interventions before primary total knee arthroplasty will improve quality of life and functional level, reduce pain and risk of early and late postoperative complications.\n\nSample size Significance level is set to 5% by using a 2-sided analysis and the power is set at 80%. Based on an expectation of a difference in patient-reported outcome scores in between the groups at 8%, as measured by SF-36 12 months postoperatively, standard deviation (SD) 13 must be include 41 participants in each group. To allow a drop-out rate of 20% the group size increases to 51 participants in each group. In total 102 participants.\n\nStatistical analysis, The two groups scores at 12 months postoperatively, and the two groups' change in the primary outcome measurer, from 1 week before surgery to 12 months postoperatively, compared with t-test or Mann-Whitney test rang sum depending on data distribution."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients recommended for primary total knee replacement.\n* Body mass index \\> 30.\n* Must be motivated for weight loss.\n* Must be able to read and understand Danish.\n\nExclusion Criteria:\n\n* Rheumatoid arthritis.\n* Patients who are operated on both knees during the project period can only participate once.\n* Planned obesity surgery.'}, 'identificationModule': {'nctId': 'NCT01469403', 'briefTitle': 'Weight Loss Intervention Before Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Weight Loss Intervention Before Total Knee Replacement, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TKABMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Standard procedure for knee arthroplasty'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weight loss program', 'description': 'The intervention program consists of 8 weeks of low-diet, using formula foods, and dietary counseling before surgery. When using formula foods the patients can achieve a quicker weight reduction and a greater reduction in fat mass than using conventional dietetic hypo caloric diet.', 'interventionNames': ['Behavioral: 8 weeks weight loss program, Cambridge.']}], 'interventions': [{'name': '8 weeks weight loss program, Cambridge.', 'type': 'BEHAVIORAL', 'description': "Fast weight losses improve the prognosis for the sustained weight loss. During the first week a dietitian will tutor the participants in formula food diet (The Cambridge Health and Weight plan UK.), followed by seven weeks with control guidance and instruction in healthy eating habits once a week. The guidance by the dietitian will be carried out both on an individual basis and in groups. The goal of the intervention is to achieve a preoperative weight loss of at least 5 to 10% of the patient's body weight, thus improving patient's health before surgery.", 'armGroupLabels': ['Weight loss program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Orthopedics Research Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Kjeld Søballe, Prof. D.Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopedics Research Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Cambridge Weight Plan Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}