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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03035435
Other study ID # Fast Track Rehab
Secondary ID
Status Completed
Phase N/A
First received January 17, 2017
Last updated July 25, 2017
Start date January 2016
Est. completion date September 2016

Study information

Verified date July 2017
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult people (>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb>9 g/l).

Exclusion Criteria:

- the presence of pain measured with NRS (NRS>4)

- rheumatoid arthritis, past surgery

- cancer

- neurological and psychiatric disorders

- dementia with Minimental Test<24

- pregnancy

- participation in the other clinical studies.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fast-track rehabilitation

standard care rehabilitation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type Measure Description Time frame Safety issue
Primary International Knee Society Score Change from Baseline fast-track rehabilitation at 8th and 15th day
Primary Merle D'Aubigne' scale Change from Baseline fast-track rehabilitation at 8th and 15th day
Secondary Barthel Index Change from Baseline fast-track rehabilitation at 8th and 15th day
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