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

NCT ID: NCT05423314

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2022-09-30

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.

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

Conditions

Anterior Cruciate Ligament Rupture

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

control

patients operated for ACLR

No interventions assigned to this group

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.

knee brace cold therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne CAVAIGNAC

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Etienne CAVAIGNAC

Role: CONTACT

cavaignac.e@chu-toulouse.fr

05 61 77 55 81 ext. +33

Isabelle OLIVIER

Role: CONTACT

olivier.i@chu-toulouse.fr

0561777051

Facility Contacts

Etienne CAVAIGNAC, MD

Role: primary

Other Identifiers

RnIPH 2021-82

Identifier Type: OTHER

Identifier Source: secondary_id

CHU de Toulouse

Identifier Type: -

Identifier Source: org_study_id