- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05470634
Trail-running After Knee or Hip Arthroplasty (TAKOHA)
Trail-running après Arthroplastie du Genou ou de la Hanche/Trail-running After Knee or Hip Arthroplasty
The incidence of indications for hip and knee arthroplasty is constantly increasing due to an increase in arthrogenic risk factors and life expectancy.
In younger patients, with a higher functional demand, resumption of physical activity and sport is a major objective after resumption of walking and pain management.
The repercussions of returning to sports after arthroplasty have been widely studied in the literature.
Few studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. The recommendations are essentially based on expert opinion.
Study Overview
Status
Conditions
Detailed Description
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).
In 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.
The 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.
Few studies have looked specifically at high-impact activities, the possibility of resuming sport and its consequences. The recommendations are essentially based on expert opinion.
Concerning 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Pierre, Réunion
- CHU de la Réunion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Trail runner (declarative)
- Having been operated for a hip or knee arthroplasty
- No limit to the length of time or volume of trail riding
Exclusion Criteria:
- Refusal to participate
- Trailer not understanding French
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Day 1
|
This impact will be assessed using : -the EuroQol Group 5D-5L (EQ5D-5L) score (with 0 being yhe worst score and 100 the best score) |
Day 1
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To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on physical activity
Time Frame: Day 1
|
This impact will be assessed using : - UCLA (University of California, Los Angeles) score 10 (ranging from wholly inactive and dependent (level 1) to regular participation in impact sports (level 10)) |
Day 1
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To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on hip problems
Time Frame: Day 1
|
This impact will be assessed 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 |
Day 1
|
To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on knee problems
Time Frame: Day 1
|
This impact will be assessed using : - 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 |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional scores of the hip and knee prostheses
Time Frame: Day 1
|
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
|
Day 1
|
Pain and satisfactory level
Time Frame: Day 1
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Evaluate the pain and satisfaction of these patients after returning to running after a prosthetic surgery using the study questionnaire
|
Day 1
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Rehabilitation and physical preparation
Time Frame: Day 1
|
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
|
Day 1
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Collaborators and Investigators
Investigators
- Principal Investigator: Cédric MAILLOT, MD, CHU La Réunion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/CHU/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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