Clinical trial NCT02895607: Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
Official title: Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 9
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the orthopedic unit for anterior cruciate ligament (ACL)

Brief 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. 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)?

b. secondary objectives

i. 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.

Eligibility criteria: Inclusion Criteria:

* Isolated ACL tear
* First arthroscopic reconstruction at DIDT

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessment of pain by visual analogue scale VAS
timeFrame: Day 45
Secondary outcomes:
measure: Assessment of sleep quality
timeFrame: Day 45
measure: Assessment of Patient satisfaction
timeFrame: Day 45
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Pierre Emmanuel MOREAU, MD
role: PRINCIPAL_INVESTIGATOR
References: