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

Anterior Cruciate Ligament Rupture Clinical Trial

— ORTHENSE  

Official title:

Participation Rate (Response Rate) and Factors Associated With Non-response to "Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423314
• Other study ID #: CHU de Toulouse
• Secondary ID: RnIPH 2021-82
• Status: Recruiting
• Start date: June 14, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Toulouse
• Contact: Etienne CAVAIGNAC
• Phone: 05 61 77 55 81
• Email: cavaignac.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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