NCT05470634

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

January 9, 2023

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 18, 2022

Last Update Submit

January 6, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Functional scores of the hip and knee prostheses

    Day 1

  • Pain and satisfactory level

    Day 1

  • Rehabilitation and physical preparation

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Trail runner (declarative)
  • Having been operated for a hip or knee arthroplasty
  • No limit to the length of time or volume of trail riding

You may not qualify if:

  • Refusal to participate
  • Trailer not understanding French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de la Réunion

Saint-Pierre, Reunion

Location

Study Officials

  • Cédric MAILLOT, MD

    CHU La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 22, 2022

Study Start

July 15, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

January 9, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations