Anterior Cruciate LigamentDIDTGENOUNCT02895607
Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
An observational study of Anterior Cruciate Ligament, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament
- What is being tested?
- Ambulatory care among eligible patients
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to May 2015
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients admitted to the orthopedic unit for anterior cruciate ligament (ACL)
Who may be able to join
- Isolated ACL tear
- First arthroscopic reconstruction at DIDT
Who cannot join
- Age over 60 years
- ASA score greater than 2
- Geographical remoteness
- Social isolation
- medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
- psychiatric pathology
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.
Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.
Read more
However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).
The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.
Read the detailed description
II. objectives
at. primary objective
Rating (or "feasibility") of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.
Evaluation criteria (absence of EG)?
- secondary objectives
- Evaluation of the acceptance rates of ambulatory care patients eligible ii. Evaluation of the rate and type of complication in our series iii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, sleep, satisfaction)
IV. Methodology and duration of the research
This is a consecutive series single-center multi-operator prospective regarding the evaluation of surgical practice cited in goal.
The inclusion of patients will take place over a period of 4 months.
The management of ACL reconstruction in outpatient will be proposed in consultation with the surgeon.
After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support AC or HC.
Clinical data will be collected by telephone the first 4 days and in consultation with J45. The revision sheet is provided.
Patients are aware of the use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.
The data collected as part of the research are anonymous and unidentifiable (for each subject is assigned a number); the name of the surgeon is also anonymized.
- Conditions
- Anterior Cruciate Ligament
- Being tested
- Ambulatory care among eligible patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory care among eligible patientsProcedure or surgery
The management of Anterior Cruciate Ligament (ACL) Reconstruction reconstruction in outpatient will be proposed in consultation with the surgeon.
After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support in CA (ambulatory surgery) or HC (conventional hospitalization).
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain by visual analogue scale VAS
Evaluation of pain by visual analogue scale (VAS was numerical scale from 0 = no pain to 10 = unbearable pain)
Measured: Day 45
Secondary outcomes (2)
Assessment of sleep quality
Quality sleep (ENS = 0 = 10 complete insomnia deep sleep without interruption)
Measured: Day 45
Assessment of Patient satisfaction
Patient satisfaction (ENS 0 = very dissatisfied to 10 = very satisfied)
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Emmanuel MOREAU, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895607
- Sponsor's protocol ID
- DIDTGENOU
- Acronym
- DIDTGENOU
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
- ClinicalTrials.gov ID
- NCT02895607
- Acronym / sponsor ID
- DIDTGENOU / DIDTGENOU
- Conditions
- Anterior Cruciate Ligament
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.
Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.
However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).
The objective of the study is to evaluate (i.e. EPP or "feasibility") ACL reconstruction in CA in hospitals, multi-operator.
Detailed description
II. objectives
at. primary objective
Rating (or "feasibility") of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.
Evaluation criteria (absence of EG)?
- secondary objectives
- Evaluation of the acceptance rates of ambulatory care patients eligible ii. Evaluation of the rate and type of complication in our series iii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, sleep, satisfaction)
IV. Methodology and duration of the research
This is a consecutive series single-center multi-operator prospective regarding the evaluation of surgical practice cited in goal.
The inclusion of patients will take place over a period of 4 months.
The management of ACL reconstruction in outpatient will be proposed in consultation with the surgeon.
After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support AC or HC.
Clinical data will be collected by telephone the first 4 days and in consultation with J45. The revision sheet is provided.
Patients are aware of the use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.
The data collected as part of the research are anonymous and unidentifiable (for each subject is assigned a number); the name of the surgeon is also anonymized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients admitted to the orthopedic unit for anterior cruciate ligament (ACL)
Key inclusion criteria (2 listed)
- Isolated ACL tear
- First arthroscopic reconstruction at DIDT
Key exclusion criteria (6 listed)
- Age over 60 years
- ASA score greater than 2
- Geographical remoteness
- Social isolation
- medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
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 |
|---|---|---|
| Ambulatory care among eligible patientsThe management of Anterior Cruciate Ligament (ACL) Reconstruction reconstruction in outpatient will be proposed in consultation with the surgeon. After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support in CA (ambulatory surgery) or HC (conventional hospitalization). | Procedure or surgery | – |
Primary outcome
Assessment of pain by visual analogue scale VAS
Time frame: Day 45
Evaluation of pain by visual analogue scale (VAS was numerical scale from 0 = no pain to 10 = unbearable pain)
2 secondary outcomes
Assessment of sleep quality
Time frame: Day 45
Assessment of Patient satisfaction
Time frame: Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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.
Pierre Emmanuel MOREAU, MD principal investigator
Fondation Hôpital Saint-Joseph
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, run by Fondation Hôpital Saint-Joseph 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 10 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain by visual analogue scale VAS (time frame: Day 45). 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 10 Aug 2018.