Anterior Cruciate Ligament RuptureORTHENSENCT05423314
"Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- knee brace cold therapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients operated for ACLR between May 2020 and April 2021
Who may be able to join
- Patients performing knee surgeries (ACL)
- 6 Weeks minimum of F/U (J+45)
- In University Hospital Toulouse
Who cannot join
- F/U = 6 weeks
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Toulouse
Etienne CAVAIGNAC, MD
About this study
Official title: Participation Rate (Response Rate) and Factors Associated With Non-response to "Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction
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.
Read the 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
- Being tested
- knee brace cold therapy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee brace cold therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: knee brace cold therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start14 Jun 2022
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne CAVAIGNAC, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423314
- Sponsor's protocol ID
- CHU de Toulouse
- Other IDs
- RnIPH 2021-82
- Acronym
- ORTHENSE
- Status last verified
- Aug 2022
- First submitted
- 14 Jun 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participation Rate (Response Rate) and Factors Associated With Non-response to "Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction
- ClinicalTrials.gov ID
- NCT05423314
- Acronym / sponsor ID
- ORTHENSE / CHU de Toulouse
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –patients operated for ACLR |
| cold therapy | – | Procedure: knee brace cold therapypatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients operated for ACLR between May 2020 and April 2021
Key inclusion criteria (3 listed)
- Patients performing knee surgeries (ACL)
- 6 Weeks minimum of F/U (J+45)
- In University Hospital Toulouse
Key exclusion criteria (1 listed)
- F/U = 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knee brace cold therapyreceiving 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 or surgery | cold therapy |
Primary outcome
percentage of change in the Online surveys Response Rate between two groups with or without knee brace cold therapy
Time frame: 45 days
percentage of Response rate to 11 surveys
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne CAVAIGNAC principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etienne CAVAIGNAC (05 61 77 55 81 ext. +33, cavaignac.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of change in the Online surveys Response Rate between two groups with or without knee brace cold therapy (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.