Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-02 @ 11:37 AM
Study NCT ID:
NCT07105657
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient acceptable symptom state (yes/no)', 'timeFrame': 'Baseline', 'description': 'Patients are asked with a single question if their current symptom state is acceptable'}, {'measure': 'Employment status (yes/no/part time)', 'timeFrame': 'Baseline'}, {'measure': 'Employment status (yes/no/part time)', 'timeFrame': '7 months'}], 'primaryOutcomes': [{'measure': 'HOOS/KOOS pain (0-100 score)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'Hip or knee related pain'}, {'measure': 'HOOS/KOOS ADL (0-100 score)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'Hip or knee related activities of daily living'}, {'measure': 'HOOS/KOOS quality of life (0-100 score)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'Hip or knee related quality of life'}, {'measure': 'HOOS/KOOS pain (0-100 score)', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'Hip or knee related pain'}, {'measure': 'HOOS/KOOS ADL (0-100 score)', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'Hip or knee related activities of daily living'}, {'measure': 'HOOS/KOOS quality of life (0-100 score)', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'Hip or knee related quality of life'}, {'measure': 'Sit-to-stand test', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'Number of completed sit to stands in 30 seconds'}, {'measure': 'Sit-to-stand test', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'Number of completed sit to stands in 30 seconds'}], 'secondaryOutcomes': [{'measure': 'Patient acceptable symptom state (yes/no)', 'timeFrame': '3 weeks follow up', 'description': 'Patients are asked with a single question if their current symptom state is acceptable'}, {'measure': 'Patient acceptable symptom state (yes/no)', 'timeFrame': '7 months follow up', 'description': 'Patients are asked with a single question if their current symptom state is acceptable'}, {'measure': 'Pain catastrophising scale (0-52 score)', 'timeFrame': 'Baseline', 'description': 'Current level of pain catastrophising with 0 being the best'}, {'measure': 'Pain catastrophising scale (0-52 score)', 'timeFrame': '3 weeks', 'description': 'Current level of pain catastrophising with 0 being the best'}, {'measure': 'Pain catastrophising scale (0-52 score)', 'timeFrame': '7 months', 'description': 'Current level of pain catastrophising with 0 being the best'}, {'measure': 'Global rating of change (0-11 score)', 'timeFrame': 'Change from baseline to 3 weeks', 'description': 'Likert scale where patients indicate their overall rating of change since the beginning of the intervention'}, {'measure': 'Global rating of change (0-11 score)', 'timeFrame': 'Change from baseline to 7 months', 'description': 'Likert scale where patients indicate their overall rating of change since the beginning of the intervention'}, {'measure': 'The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'EQ5D5L scores'}, {'measure': 'The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)', 'timeFrame': 'Change from 3 weeks to 7 mothns', 'description': 'EQ5D5L scores'}, {'measure': 'EQ5D VAS (0-100 scale)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'EQ5D Vas overall health'}, {'measure': 'EQ5D VAS (0-100 scale)', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'EQ5D Vas overall health'}, {'measure': 'HOOS/KOOS symptoms (0-100 score)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'Hip or knee related symptoms'}, {'measure': 'HOOS/KOOS symptoms (0-100 score)', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'Hip or knee symptoms'}, {'measure': 'HOOS/KOOS sport/rec (0-100 score)', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'Hip or knee related sport/rec'}, {'measure': 'HOOS/KOOS sport/rec (0-100 score)', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'Hip or knee related sport/rec'}, {'measure': '6 minute walk test', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'The distance a patient can walk in 6 minutes'}, {'measure': '6 minute walk test', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'The distance a patient can walk in 6 minutes'}, {'measure': '40 meter fast paced walk test', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'The time a patient uses walking 40 meters fast'}, {'measure': '40 meter fast paced walk test', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'The time a patient uses walking 40 meters fast'}, {'measure': 'Stair test', 'timeFrame': 'Change from baseline (0) to 3 weeks', 'description': 'The time a patient uses to ascend and decend a staircase'}, {'measure': 'Stair test', 'timeFrame': 'Change from 3 weeks to 7 months', 'description': 'The time a patient uses to ascend and decend a staircase'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total hip replacement', 'rehabilitation', 'hip osteoartritis', 'knee osteoarthritis', 'total knee replacement'], 'conditions': ['Hip Osteoarthritis', 'Knee Osteoarthristis']}, 'descriptionModule': {'briefSummary': 'Patients with total hip or knee replacement experiencing persistant problems are offered 3 weeks of intensive rehabilitation.', 'detailedDescription': 'Outcomes before, at the end of treatment and at 6 months follow up will be investigated. Data will be handled separately for the two groups of patients: 42 with a total hip replacement and 42 with a total knee replacement. Specific and generic outcomes will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have a total hip or knee replacement experiencing persistant problems, hence are admitted to a 3 week intensive rehabilitation period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with a total hip or knee replacement admitted for intensive rehabilitation\n\nExclusion Criteria:\n\n* Patients unable to understand Danish\n* Unable to participate in physical tests\n* Unable to understand questionaires\n* Unable to participate i 6 months follow up'}, 'identificationModule': {'nctId': 'NCT07105657', 'acronym': 'Rehab-hip-knee', 'briefTitle': 'The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments', 'organization': {'class': 'OTHER', 'fullName': 'Horsens Hospital'}, 'officialTitle': 'The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments', 'orgStudyIdInfo': {'id': '1-16-02-329-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group hip', 'description': 'Patients with a total hip replacement undergoing rehabilitation', 'interventionNames': ['Other: Rehabilitation']}, {'label': 'Intervention group knee', 'description': 'Patients with a total hip replacement undergoing rehabilitation', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'Three weeks intensive rehabilitation where patients undergo group-based and individualised rehabilitation focusing at improving pain, function and quality of life for the patient', 'armGroupLabels': ['Intervention group hip', 'Intervention group knee']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brædstrup', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Signe Kierkegaard-Brøchner, PhD', 'role': 'CONTACT', 'email': 'signkier@rm.dk', 'phone': '004578427882'}, {'name': 'Signe Kierkegaard-Brøchner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stian Langgård Jørgensen, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Horsens Regional Hospital', 'geoPoint': {'lat': 55.97153, 'lon': 9.61129}}], 'centralContacts': [{'name': 'Signe Kierkegaard-Brøchner, PhD', 'role': 'CONTACT', 'email': 'signkier@rm.dk', 'phone': '004578427882'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Horsens Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'VIA University College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. prof.', 'investigatorFullName': 'Jeppe Lange', 'investigatorAffiliation': 'Horsens Hospital'}}}}