Anterior Cruciate Ligament Clinical Trial
— DIDTGENOUOfficial title:
Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
NCT number | NCT02895607 |
Other study ID # | DIDTGENOU |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2014 |
Est. completion date | May 2015 |
Verified date | September 2016 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Day 45 | |
Secondary | Assessment of sleep quality | Quality sleep (ENS = 0 = 10 complete insomnia deep sleep without interruption) | Day 45 | |
Secondary | Assessment of Patient satisfaction | Patient satisfaction (ENS 0 = very dissatisfied to 10 = very satisfied) | Day 45 |
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