Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-29 @ 4:09 AM
Study NCT ID:
NCT06024161
Status:
UNKNOWN
Last Update Posted:
2023-09-06
First Post:
2023-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-29', 'size': 278218, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-29T04:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6400}, 'targetDuration': '15 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate/Severe Persistent Postoperative Pain', 'timeFrame': '11-15 months postsurgically', 'description': "The primary outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip or knee, defined as patients with a numerical rating scale (NRS) score higher than 3.\n\nThe outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)"}], 'secondaryOutcomes': [{'measure': 'Satisfaction', 'timeFrame': '11-15 months postsurgically', 'description': 'Answering with "satisfied" or "very satisfied" in satisfaction question The outcome will be presented as Odd Ratio (OR) with its\' corresponding 95% Confidence Interval (CI)'}, {'measure': 'Willingness to repeat the surgery', 'timeFrame': '11-15 months postsurgically', 'description': 'Answering "yes" in willlingness question The outcome will be presented as Odd Ratio (OR) with its\' corresponding 95% Confidence Interval (CI)'}, {'measure': 'Frequent pain', 'timeFrame': '11-15 months postsurgically', 'description': "Experiencing pain constantly, daily or few times a week The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)"}, {'measure': 'Use of analgaesic', 'timeFrame': '11-15 months postsurgically', 'description': "The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)"}, {'measure': 'Interference with daily activities', 'timeFrame': '11-15 months postsurgically', 'description': 'Answering "some", "much" and "very much" in the interference question The outcome will be presented as Odd Ratio (OR) with its\' corresponding 95% Confidence Interval (CI)'}, {'measure': 'WOMAC pain score', 'timeFrame': '11-15 months postsurgically', 'description': 'mean (standard deviaiton \\[SD\\]). We will report the mean difference (MD) and the corresponding 95% CI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Persistent Postsurgical Pain', 'Arthritis Knee', 'Arthropathy of Knee', 'Arthropathy of Hip', 'Weight Loss', 'Weight Gain', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The study is a nationwide, register-based cohort survey study. The objective of this study is to investigate whether weight change is associated with the incidence of persistent postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese and obese and patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be identified based on the NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures from the the Danish National Patient Register by using SKS-code the codes for THA patients will be SKS-code DM16 \\[hip osteoarthritis\\] + KNFB20 or KNFB30 or KNFB40\\[Primary Total Hip Arthroplasty\\]. For total knee arthroplasty (TKA), SKS-code DM17 \\[knee osteoarthritis\\] + KNGB20, KNGB30 or KNGB40 \\[primary total knee arthroplasty\\]. For medial unicompartmental knee arthroplasty (UKA), SKS-code DM17 \\[knee osteoarthritis\\] + KNGB01 or KNGB11 \\[primary medial unicompartmental knee arthroplasty\\].', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months before survey distribution\n\nExclusion Criteria:\n\n* Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.'}, 'identificationModule': {'nctId': 'NCT06024161', 'briefTitle': 'Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties: A Nationwide Registry-based Cohort Survey Study.', 'orgStudyIdInfo': {'id': 'p-2023-14578'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Weight gainers', 'description': 'Weight gain 11-15 months after arthroplasty', 'interventionNames': ['Other: Weight gain']}, {'label': 'Weight losers', 'description': 'Weight loss11-15 months after arthroplasty', 'interventionNames': ['Other: Weight loss']}, {'label': 'Weight unchanged', 'description': 'Weight unchanged 11-15 months after arthroplasty', 'interventionNames': ['Other: Weight unchanged']}], 'interventions': [{'name': 'Weight gain', 'type': 'OTHER', 'description': '≥5% weight gain', 'armGroupLabels': ['Weight gainers']}, {'name': 'Weight loss', 'type': 'OTHER', 'description': '≥5% weight loss after arthroplasty', 'armGroupLabels': ['Weight losers']}, {'name': 'Weight unchanged', 'type': 'OTHER', 'description': '\\<5% weight change after arthroplasty', 'armGroupLabels': ['Weight unchanged']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Saber M. Saber, MD', 'role': 'CONTACT', 'email': 'ssab0009@regionh.dk', 'phone': '004521299265'}, {'name': 'Jens Laigaard, MD', 'role': 'CONTACT', 'email': 'jens.holm.laigaard@regionh.dk'}], 'overallOfficials': [{'name': 'Søren Overgaard, MD,DMSc,Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of orthopedic surgery, Bispebjerg University Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD fellow', 'investigatorFullName': 'Saber Muthanna Saber', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}