Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT05470634
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trail-running After Knee or Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on the quality of life', 'timeFrame': 'Day 1', 'description': 'This impact will be assessed using :\n\n-the EuroQol Group 5D-5L (EQ5D-5L) score (with 0 being yhe worst score and 100 the best score)'}, {'measure': 'To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on physical activity', 'timeFrame': 'Day 1', 'description': 'This impact will be assessed using :\n\n\\- UCLA (University of California, Los Angeles) score 10 (ranging from wholly inactive and dependent (level 1) to regular participation in impact sports (level 10))'}, {'measure': 'To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on hip problems', 'timeFrame': 'Day 1', 'description': 'This impact will be assessed using :\n\n\\- the HOOS12 scale (Hip and Osteoarthritis Outcome Score) with 12 questions scored from 1 to 4 each, with 0 representing no hip problems and 4 representing extreme hip problems'}, {'measure': 'To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on knee problems', 'timeFrame': 'Day 1', 'description': 'This impact will be assessed using :\n\n\\- KOOS12 scale (Knee and Osteoarthritis Outcome Score) with 12 questions scored from 1 to 4 each, with 0 representing no knee problems and 4 representing extreme knee problems'}], 'secondaryOutcomes': [{'measure': 'Functional scores of the hip and knee prostheses', 'timeFrame': 'Day 1', 'description': 'Compare the functional scores of the hip and knee prostheses of these patients using the HOOS12 scale (Hip and Osteoarthritis Outcome Score) with 12 questions scored from 1 to 4 each, with 0 representing no hip problems and 4 representing extreme hip problems and the KOOS12 scale (Knee and Osteoarthritis Outcome Score) with 12 questions scored from 1 to 4 each, with 0 representing no knee problems and 4 representing extreme knee problems'}, {'measure': 'Pain and satisfactory level', 'timeFrame': 'Day 1', 'description': 'Evaluate the pain and satisfaction of these patients after returning to running after a prosthetic surgery using the study questionnaire'}, {'measure': 'Rehabilitation and physical preparation', 'timeFrame': 'Day 1', 'description': 'To analyse the rehabilitation and physical preparation of these patients that allowed them to return to sport after hip and knee prothesis implantation using the study questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthropathy of Knee', 'Arthropathy of Hip']}, 'descriptionModule': {'briefSummary': 'The incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy.\n\nIn younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management.\n\nThe repercussions of returning to sports after arthroplasty have been widely studied in the literature.\n\nFew studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. The recommendations are essentially based on expert opinion.', 'detailedDescription': 'The incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy. Projections predict an increase in the number of prosthetic surgeries between 2020 and 2030 of 150% for total hip replacements (THR) and 230% for total knee replacements (TKR).\n\nIn younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management. They are also more likely to resume physical activities with high peak joint stresses, known as "high-impact sports", most often against the advice of their surgeon.\n\nThe repercussions of returning to sports after arthroplasty have been widely studied in the literature. These are essentially descriptive cross-sectional studies which show greater participation in low or medium impact sports activities in patients with prostheses.\n\nFew studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. The recommendations are essentially based on expert opinion.\n\nConcerning trail running, a discipline in full expansion, particularly in the longest formats; a single study in 2019, involving 18 runners with a prosthesis, did not reveal any specific constraints compared to healthy runners during a 170 km ultratrail.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruitment process will involve a pre-recruitment informing runners that we are looking for trail runners of all levels who have undergone hip and knee replacement surgery. This information will be disseminated via social networks, trail clubs, and via the organisers of major trail races (Diagonale des Fous, UTMB). We will then send the questionnaires to all the runners who have replied to us and mentioned their willingness to participate in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trail runner (declarative)\n* Having been operated for a hip or knee arthroplasty\n* No limit to the length of time or volume of trail riding\n\nExclusion Criteria:\n\n* Refusal to participate\n* Trailer not understanding French'}, 'identificationModule': {'nctId': 'NCT05470634', 'acronym': 'TAKOHA', 'briefTitle': 'Trail-running After Knee or Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Trail-running après Arthroplastie du Genou ou de la Hanche/Trail-running After Knee or Hip Arthroplasty', 'orgStudyIdInfo': {'id': '2022/CHU/14'}}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Pierre', 'country': 'Reunion', 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'overallOfficials': [{'name': 'Cédric MAILLOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU La Réunion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}