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

Completed

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

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-Pierre, Réunion
        • CHU de la Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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
Evaluate the pain and satisfaction of these patients after returning to running after a prosthetic surgery using the study questionnaire
Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cédric MAILLOT, MD, CHU La Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

July 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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