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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05470634
Other study ID # 2022/CHU/14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2022
Est. completion date September 15, 2022

Study information

Verified date July 2022
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date September 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Réunion CHU de la Réunion Saint-Pierre

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Primary To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on physical activity 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
Primary To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on hip problems 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
Primary To evaluate the impact of trail running on patients who have undergone prosthetic surgery (total or partial hip or knee arthroplasty) on knee problems 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 Functional scores of the hip and knee prostheses 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
Secondary Pain and satisfactory level Evaluate the pain and satisfaction of these patients after returning to running after a prosthetic surgery using the study questionnaire Day 1
Secondary Rehabilitation and physical preparation 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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