NCT05423314

Brief Summary

To monitor the quality of health care systems, patient-reported outcome measures (PROMs) should be collected and analyzed before and after medical interventions. The development of information technology and software along with an exponential increase in the use of the Internet now allows new modalities for collecting PROMs. Online survey has become one of the most popular methods of data collection. tHE hypothesis is that providing a "brace cold therapy" to patients undergoing knees surgeries will generate an increasing in Response Rate to Online surveys.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

June 14, 2022

Last Update Submit

August 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of change in the Online surveys Response Rate between two groups with or without knee brace cold therapy

    percentage of Response rate to 11 surveys

    45 days

Study Arms (2)

control

patients operated for ACLR

cold therapy

patients operated for ACLR, and received a "knee brace cold therapy" to use it in the post op recovery rehabilitation, sent to patient's home directly during pre-op phase.

Procedure: knee brace cold therapy

Interventions

receiving a "knee brace cold therapy" to use it in the post op recovery rehabilitation, sent to patient's home directly during pre-op phase.

cold therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients operated for ACLR between May 2020 and April 2021

You may qualify if:

  • Patients performing knee surgeries (ACL)
  • Weeks minimum of F/U (J+45)
  • In University Hospital Toulouse

You may not qualify if:

  • F/U = 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Etienne CAVAIGNAC

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Study Start

June 14, 2022

Primary Completion

August 30, 2022

Study Completion

September 30, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations