ORTHENSE: "Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05423314
Collaborator
(none)
100
1
3.5
28.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: knee brace cold therapy

Detailed Description

In the setting of anterior cruciate ligament reconstruction (ACLR), an alternative to standard clinic-based follow-up is used in our institution via the utilization of Web-Based follow-up platform (OTHENSE) that allows surgeons to monitor a patient's subjective quality of recovery, including symptoms of pain and limitations in activities of daily living. This tool has the potential to enhance quality of care by providing weekly updates about the patient's physical impairment. We started using it in 2018.

From a single orthopedic surgeon, a total of 100 patients who were planned to undergo an ACLR requiring formal post-operative follow-up were participated.

The process began upon preop consultation, where the patient is offered a description of the survey and asked to use a link allowing direct access to the Online Surveys (ORTHENSE Platform).

• Participants were divided in two groups :

  • First group: patients operated for ACLR

  • Second group: 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.

A standardized follow-up protocol for both groups.

The surveys included questions related to rehabilitation and questions from standard patient-reported-outcome-measures PROMs. They were asked to complete the following surveys pre-operatively and post-operatively:

J -14 / J-7 / J -5/ J-2 / J+3 / J+7 / J+14 / J+21 / J+28 / J+35 / J+45

For both groups, data was collected for up to 6 weeks following Surgery (J+45), for a total of 11 surveys

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Participation Rate (Response Rate) and Factors Associated With Non-response to "Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction
Actual Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. percentage of change in the Online surveys Response Rate between two groups with or without knee brace cold therapy [45 days]

    percentage of Response rate to 11 surveys

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients performing knee surgeries (ACL)

  • 6 Weeks minimum of F/U (J+45)

  • In University Hospital Toulouse

Exclusion Criteria:
  • F/U = 6 weeks

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse France

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Etienne CAVAIGNAC, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05423314
Other Study ID Numbers:
  • CHU de Toulouse
  • RnIPH 2021-82
First Posted:
Jun 21, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022